Thalidomide has immunomodulatory, antiangiogenic, and antitumor properties, although its exact mechanism of action is unknown. It is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. It is not indicated as monotherapy for acute ENL treatment in the presence of moderate to severe neuritis. Thalidomide is also indicated in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma. Thalidomide is a known teratogen that may cause birth defects or embryo-fetal death. Routine pregnancy testing is required in females of reproductive potential. All prescribers, pharmacists, and patients must be registered in the THALOMID REMS program to prescribe, dispense, or receive thalidomide. Information about the drug and the program can be found at www.thalomidrems.com or by calling 1-888-423-5436.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
All prescribers, patients, and pharmacists must comply with the conditions of the THALOMID REMS program when prescribing, dispensing, or receiving thalidomide. Information about the drug and the program can be found at www.celgeneriskmanagement.com or by calling 1-888-423-5436.
Hazardous Drugs Classification
-NIOSH 2016 List: Group 2
-NIOSH (Draft) 2020 List: Table 1
-Observe and exercise appropriate precautions for handling, preparation, administration, and disposal of hazardous drugs.
-Use gloves to handle. Cutting, crushing, or otherwise manipulating tablets/capsules will increase exposure.
-Maintain storage of capsules in blister packs until taken. Wash the exposed area immediately and thoroughly with soap and water if powder from thalidomide capsules come into contact with skin; flush thoroughly with water if thalidomide comes into contact with mucous membranes.
Emetic Risk
-Minimal/Low
-Administer prn antiemetics as necessary.
Route-Specific Administration
Oral Administration
Oral Solid Formulations
-Take thalidomide once daily at least 1 hour after the evening meal, preferably at bedtime.
-Swallow capsules whole; do not crush, break, or chew.
-If a dose is missed, take within 12 hours of missing the dose. If more than 12 hours have passed, skip the dose of the day and take the dose the next day at the scheduled time.
-No more than a 28-day supply should be dispensed at one time.
Teratogenesis has occurred following thalidomide use during pregnancy. A high incidence of severe and life-threatening birth defects was reported; some cases occurred after only a single dose. Fetal death that occurred at or shortly after birth has been reported in about 40% of infants. If pregnancy occurs during thalidomide treatment, the drug should be discontinued immediately. Thalidomide is approved for marketing through a special restricted distribution program called the THALOMID REMS program. If a patient becomes pregnant while taking thalidomide, apprise the patient of the potential hazard to the fetus. Also, report any suspected fetal exposure to thalidomide to a Pregnancy Exposure Registry via the MedWatch program at 1-800-FDA-1088 and to Celgene Corporation at 1-888-423-5436.
Venous and arterial thromboembolism has been reported in patients with multiple myeloma who received thalidomide. Monitor patients for signs and symptoms of thromboembolism. Consider thromboprophylaxis based on an assessment of individual patient risk factors. Deep vein thrombosis (13% vs. 2%), pulmonary embolism (PE) (7% vs. 2%), cerebrovascular accident/stroke (2.6% vs. 0.9%), and ischemic heart disease (11.1% vs. 4.7%) including myocardial ischemia (3% vs. 1%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in a randomized clinical trial; myocardial infarction (MI) occurred in 1.3% of patients in the thalidomide and dexamethasone arm. Thromboembolism occurred in 22.5% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 4.9% of patients who received dexamethasone alone (n = 102) in a randomized clinical trial (p = 0.002). PE was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Stroke was reported in postmarketing surveillance of thalidomide.
Fatigue occurred in 79% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 71% of patients who received dexamethasone alone (n = 102) in a randomized trial; grade 3 or 4 fatigue was reported in 17% of patients in the thalidomide and dexamethasone arm. Asthenia (24% vs. 20%) and fatigue (21% vs. 16%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in another randomized trial; grade 3 or 4 asthenia occurred in 5% of patients in the thalidomide and dexamethasone arm. Asthenia was reported in 8% of patients with erythema nodosum leprosum who received thalidomide 50 to 300 mg/day (n = 24).
Severe and irreversible peripheral neuropathy has been reported in 54% or less of patients who received thalidomide in clinical trials. Symptoms may occur during therapy or after treatment is discontinued; the correlation of neuropathy with cumulative dose is unclear. Monitor patients for signs of neuropathy monthly for the first 3 months and then periodically thereafter. Consider electrophysiologic testing consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baseline and then every 6 months to detect asymptomatic neuropathies. In patients with multiple myeloma who develop peripheral neuropathy, consider therapy interruption or a dose reduction. Therapy interruption, a dose reduction, or therapy discontinuation may be necessary in any patient who develops grade 3 or 4 peripheral neuropathy. Sensory (54% vs. 28%) and motor (22% vs. 16%) peripheral neuropathy were reported more often in multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 sensory (4%) and motor (8%) peripheral neuropathy occurred in the thalidomide and dexamethasone arm. Paresthesias (12% vs. 6%) and peripheral sensory neuropathy (10% vs. 5%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in another randomized clinical trial; grade 3 or 4 peripheral neuropathy occurred in 3% of patients in the thalidomide and dexamethasone arm. Hypoesthesia and polyneuropathy were also reported in this study. Causalgia, circumoral paresthesia, hyperesthesia, neuralgia, neuritis, neuropathy, paresthesias, and peripheral neuritis were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum.
Fever occurred in 24% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 20% of patients who received dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 fever occurred in 1% of patients in the thalidomide and dexamethasone arm. Chills occurred in 4% of patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24). Fever was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL.
Gastrointestinal (GI) toxicity including constipation (4% to 55%), nausea (4% to 28%), and dry mouth/xerostomia (4% to 12%) has been reported in patients who received thalidomide in clinical trials. Anorexia (28% vs. 24%), constipation (55% vs. 28%), nausea (28% vs. 22%), and xerostomia (12% vs. 6%) were reported more often in multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 anorexia (4%), constipation (8%), nausea (5%) and xerostomia (1%) occurred in the thalidomide and dexamethasone arm. Constipation (50% vs. 21%), dyspepsia (11% vs. 9%), and nausea (13% vs. 12%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in another randomized clinical trial; grade 3 or 4 constipation occurred in 3% of patients in the thalidomide and dexamethasone arm. Vomiting, xerostomia, peritonitis, and diverticular/GI perforation were also reported in this study. Abdominal pain, constipation, diarrhea, nausea, oral moniliasis, and tooth pain each occurred in 1 patient (4%) with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24). Anorexia, enlarged abdomen, xerostomia, dyspepsia, eructation, flatulence, GI obstruction, and vomiting were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL. Additionally, GI perforation, stomach/peptic ulcer, aphthous ulcer, and stomatitis were reported in postmarketing surveillance of thalidomide.
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) were reported in postmarketing surveillance of thalidomide; some cases were fatal. Hold or consider discontinuing therapy in patients who develop a grade 2 or 3 skin rash. Discontinue therapy in patients who develop a grade 4 skin rash, exfoliative or bullous rash, or other severe cutaneous toxicity (e.g., SJS, TEN, or DRESS); do not resume therapy in these patients. DRESS may present with a cutaneous reaction (e.g., rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Dermatologic adverse events (47% vs. 34%) including rash/desquamation (30% vs. 18%) and xerosis (21% vs. 11%) were reported more often in multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 dermatologic toxicity (5%) including rash/desquamation (4%) occurred in the thalidomide and dexamethasone arm. Fungal dermatitis (4%), nail disorder (4%), pruritus (8%), rash (21%), and maculopapular rash (4%) occurred in patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24). Acne vulgaris, alopecia, xerosis, eczematous rash, exfoliative dermatitis, ichthyosis, perifollicular thickening, skin necrosis, seborrhea, sweating/hyperhidrosis, and vesiculo-bullous rash were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL. Erythema multiforme, erythema nodosum, TEN, and purpura were reported in postmarketing surveillance of thalidomide.
Hematologic toxicity has been reported in patients who received thalidomide in clinical trials. Monitor complete blood counts at baseline and periodically during therapy. Observe patients for signs and symptoms of bleeding including GI bleeding. If severe hematologic toxicity occurs, consider therapy interruption, a dose reduction, or therapy discontinuation. Neutropenia/decreased neutrophil count (31% vs. 24%) and leukopenia/decreased leukocyte count (35% vs. 29%) were reported more often in multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 decreased neutrophil count (10%) and decreased leukocyte count (6%) occurred in the thalidomide and dexamethasone arm. Grade 3 or 4 neutropenia occurred in 3% of patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) in a randomized clinical trial. Other adverse events including decreased erythrocyte sedimentary rate, eosinophilia, epistaxis, granulocytopenia, hypochromic anemia, leukocytosis, leukopenia, elevated mean corpuscular volume value, abnormal red blood cell concentration, palpable spleen (splenomegaly), and thrombocytopenia were reported in patients with erythema nodosum leprosum who received thalidomide doses up to 400 mg/day in uncontrolled studies. Pancytopenia, lymphopenia, petechiae, neutropenia, febrile neutropenia, erythroleukemia, and prothrombin time changes have been reported in postmarketing surveillance of patients who received thalidomide.
Cardiotoxicity including hypotension has been reported in patients who received thalidomide in clinical trials. Grade 3 or 4 atrial fibrillation was reported in 5% of patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) in a randomized clinical trial. Hypertension, hypotension, peripheral vascular disorder, sinus tachycardia, and peripheral vasodilation were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Sick sinus syndrome and EKG abnormalities were reported in postmarketing surveillance of thalidomide.
Dizziness (4% to 23%) and orthostatic hypotension have been reported in patients who received thalidomide in clinical trials. Advise patients to sit upright for a few minutes before standing up from a lying or seated position to lower the risk of these side effects. Dizziness/lightheadedness occurred in 20% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 14% of patients who received dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 dizziness/lightheadedness was reported in 1% of patients in the thalidomide and dexamethasone arm. Dizziness (23% vs. 14%) was reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in a randomized clinical trial. Orthostatic hypotension was also reported in this trial. Dizziness occurred in 4% of patients with erythema nodosum leprosum who received thalidomide 50 to 300 mg/day (n = 24).
Seizures including grand mal convulsions and status epilepticus have been reported in postmarketing surveillance of thalidomide. Closely monitor patients with a history of seizure disorder or with risk factors for developing seizures for clinical changes that could precipitate acute seizure activity. Other neurologic adverse events including drowsiness or somnolence have been reported in patients who received thalidomide in clinical trials. Consider therapy interruption or a dose reduction in patients with multiple myeloma who develop somnolence. Confusion (28% vs. 12%), tremor (26% vs. 6%), and depressed level of consciousness (16% vs. 3%) occurred more often in multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 confusion (9%), tremor (1%), and depressed level of consciousness (3%) were reported in the thalidomide and dexamethasone arm. Tremor (26% vs. 12%) was reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in another randomized clinical trial; grade 3 or 4 confusion occurred in 2% of patients in the thalidomide and dexamethasone arm. Somnolence was also reported in this trial. Somnolence (38%), headache (13%), and tremor (4%) occurred in patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24). Confusion was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL. Additionally, disturbances in consciousness including lethargy, loss of consciousness or stupor, migraine, foot drop, Parkinson disease, carpal tunnel syndrome, and Raynaud syndrome were reported in postmarketing surveillance of thalidomide.
Tumor lysis syndrome (TLS) has been reported in postmarketing surveillance of thalidomide. Monitor patients at risk for TLS (e.g., high tumor burden prior to treatment). Take precautionary measures (e.g., hydration, uric acid lowering therapy) as appropriate in these patients.
Hypocalcemia (72% vs. 59%) occurred more often in multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 hypocalcemia was reported in 11% of patients in the thalidomide and dexamethasone arm. Grade 3 or 4 hypokalemia (3% vs. 1%) was reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in another randomized clinical trial. Electrolyte abnormalities, hyperkalemia, hyperuricemia, hypocalcemia, and decreased phosphorus level/hypophosphatemia were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Additionally, electrolyte abnormalities including hypercalcemia, hyponatremia, and hypomagnesemia were reported in postmarketing surveillance of thalidomide.
Hyperbilirubinemia occurred in 14% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 10% of patients who received dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 hyperbilirubinemia was reported in 2% of patients in the thalidomide and dexamethasone arm. Hyperbilirubinemia, increased LDH level, elevated hepatic enzymes (i.e., increased ALT level), and hypoproteinemia were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Increased alkaline phosphatase level was reported in postmarketing surveillance of thalidomide.
Edema occurred in 56% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 46% of patients who received dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 edema occurred in 6% of patients in the thalidomide and dexamethasone arm. Peripheral edema (34% vs. 25%) and edema (13% vs. 8%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in another randomized clinical trial. Peripheral edema and facial edema each occurred in 4% of patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24). Edema was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL.
Hypothyroidism and myxedema were reported in postmarketing surveillance of thalidomide.
Impotence (erectile dysfunction) occurred in patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24). Orchitis was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL. Amenorrhea, sexual dysfunction, galactorrhea, gynecomastia, and metrorrhagia were reported in postmarketing surveillance of thalidomide.
Pulmonary hypertension has been reported in postmarketing surveillance of thalidomide.
Infection has been reported in patients who received thalidomide in clinical trials. Pneumonia was reported in 15% of patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with 12% of patients who received placebo and dexamethasone (n = 232) in a randomized clinical trial; grade 3 or 4 pneumonia (7%) and bronchopneumonia (3%) occurred in patients in the thalidomide and dexamethasone arm. Bronchitis was also reported in this trial. Upper respiratory infection was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Infections including severe infections (e.g., fatal sepsis including septic shock), viral infections (e.g., varicella zoster virus, cytomegalovirus, and hepatitis B exacerbation/reactivation), and progressive multifocal leukoencephalopathy have been reported in postmarketing surveillance of thalidomide.
New primary malignancy has occurred in patients who received thalidomide. Leukemia and amyloidosis were reported in patients with erythema nodosum leprosum who received thalidomide doses up to 400 mg/day in uncontrolled studies. Nodular sclerosing Hodgkin lymphoma and erythroleukemia have been reported in postmarketing surveillance of thalidomide.
Bradycardia has been reported in patients who received thalidomide in clinical trials. Monitor all patients for signs and symptoms of bradycardia and syncope. Therapy interruption or discontinuation may be necessary in patients who develop bradycardia. Grade 3 or 4 syncope was reported in 3% of patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) in a randomized clinical trial.
Psychiatric adverse events have been reported in patients who received thalidomide in clinical trials. Anxiety/agitation occurred in 26% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 14% of patients who received dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 anxiety/agitation was reported in 1% of patients in the thalidomide and dexamethasone arm. Anxiety (12% vs. 10%) and depression (10% vs. 8%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in a randomized clinical trial; grade 3 or 4 anxiety occurred in 2% of patients in the thalidomide and dexamethasone arm. Mood alteration was also reported in this trial. Abnormal thinking, agitation, amnesia, anxiety, depression, euphoria, insomnia, nervousness, and psychosis were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Changes in mental status or mood including suicidal ideation/attempts were reported in postmarketing surveillance of thalidomide.
Hyperglycemia (15% vs. 14%) was reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) compared with placebo and dexamethasone (n = 232) in a randomized clinical trial. Hyperglycemia and diabetes mellitus were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum.
Respiratory adverse events have been reported in patients who received thalidomide in clinical trials. Dyspnea occurred in 42% of multiple myeloma patients who received thalidomide and dexamethasone (n = 102) compared with 31% of patients who received dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 dyspnea occurred in 13% of patients in the thalidomide and dexamethasone arm. Pharyngitis, rhinitis, and sinusitis each occurred in 4% of patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24). Cough, emphysema, rales, and voice alteration were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL. Pleural effusion and interstitial lung disease were reported in postmarketing surveillance of thalidomide.
Syndrome of inappropriate antidiuretic hormone (SIADH) was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum.
Cyanosis was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum.
Musculoskeletal adverse events have been reported in patients who received thalidomide in clinical trials. Myalgia (17% vs. 14%), arthralgia (13% vs. 10%), and muscle weakness (40% vs. 37%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 muscle weakness occurred in 6% of patients in the thalidomide and dexamethasone arm. Back pain, neck pain, and neck rigidity each occurred in 4% of patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24); pain was reported in 8.3% of patients. Upper extremity pain, arthritis, bone tenderness, hypertonia, joint disorder, leg muscle cramps, myalgia, myasthenia, and periosteal disorder were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with ENL.
Weight loss (23% vs. 21%) and weight gain (22% vs. 13%) were reported more often in patients with multiple myeloma who received thalidomide and dexamethasone (n = 102) compared with dexamethasone alone (n = 102) in a randomized clinical trial; grade 3 or 4 weight loss and weight gain each occurred in 1% of patients in the thalidomide and dexamethasone arm. Grade 3 or 4 weight gain occurred in 3% of patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) in another randomized clinical trial. Additionally, weight gain was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum.
Grade 3 or 4 vertigo occurred in 2% of patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) in a randomized clinical trial. Vertigo was reported in 8% of patients with erythema nodosum leprosum who received thalidomide 50 to 300 mg/day (n = 24).
Photosensitivity was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum.
Blurred vision was reported in patients with multiple myeloma who received thalidomide and dexamethasone (n = 234) in a randomized clinical trial. Amblyopia, xerophthalmia, and ocular pain were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Diplopia and nystagmus were reported in postmarketing surveillance of thalidomide.
Deafness/hearing loss and tinnitus were reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Hearing impairment was reported in postmarketing surveillance of thalidomide.
Malaise occurred in 8% of patients with erythema nodosum leprosum (ENL) who received thalidomide 50 to 300 mg/day (n = 24).
Increased serum creatinine level, increased BUN level, decreased creatinine clearance, hematuria, proteinuria, pyuria, and increased urinary frequency occurred with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum. Renal failure (unspecified), acute renal failure, oliguria, and enuresis were reported in postmarketing surveillance of thalidomide.
Hypersensitivity reactions including anaphylactoid reactions and solid organ transplant rejection were reported in postmarketing surveillance of thalidomide. Hold therapy if a severe reaction occurs; discontinue thalidomide if the reaction recurs after resuming therapy. Do not resume therapy in patients who develop angioedema or anaphylaxis. Symptoms of an allergic reaction may include erythematous macular rash associated with fever, tachycardia, and hypotension. Urticaria was reported with thalidomide doses up to 400 mg/day in uncontrolled studies in patients with erythema nodosum leprosum.
Use of thalidomide is contraindicated in patients with a history of thalidomide hypersensitivity or hypersensitivity to any component of the product. Hypersensitivity reactions (e.g., angioedema and anaphylactic reactions) have been reported with thalidomide therapy. Hold therapy if a severe reaction occurs; discontinue thalidomide if the reaction recurs after resuming therapy. Do not resume therapy in patients who develop angioedema or anaphylaxis. Serious rash including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported; some cases were fatal. Hold or consider discontinuing therapy in patients who develop a grade 2 or 3 skin rash. Discontinue therapy in patients who develop a grade 4 skin rash, exfoliative or bullous rash, or other severe cutaneous toxicity (e.g., SJS, TEN, or DRESS); do not resume therapy in these patients.
Venous (e.g., pulmonary embolism, deep vein thrombosis) and arterial (e.g., stroke, myocardial infarction (MI)) thromboembolism has been reported in patients with multiple myeloma who received thalidomide. Using thalidomide in combination with chemotherapy agents, including dexamethasone, may increase the risk of thromboembolism (TE); use caution when administering thalidomide with chemotherapy agents or other agents that may increase the risk of TE (e.g., estrogen-containing contraceptives). Monitor patients for signs and symptoms of a blood clot such as dyspnea, chest pain, and arm or leg swelling; a stroke such as sudden numbness or weakness (especially on one side of the body), severe headache or confusion, or problems with vision, speech, or balance; and a MI such as feeling sweaty, shortness of breath, feeling sick or vomiting, and/or chest pain that may spread to the arms, neck, jaw, back, or stomach. Consider thromboprophylaxis based on an assessment of individual patients' underlying risk factors.
Severe and irreversible peripheral neuropathy may occur with thalidomide therapy. Symptoms may occur during therapy or after treatment is discontinued; the correlation of neuropathy with cumulative dose is unclear. Use thalidomide and other medications associated with neuropathy together with caution due to the risk of additive toxicity. Examine patients for signs of neuropathy monthly for the first 3 months and then periodically thereafter. Consider electrophysiologic testing consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baseline and then every 6 months to detect asymptomatic neuropathies. In patients with multiple myeloma who develop peripheral neuropathy, consider therapy interruption or a dose reduction. Therapy interruption, a dose reduction, or therapy discontinuation may be necessary in any patient who develops grade 3 or 4 peripheral neuropathy.
Thalidomide may cause drowsiness and somnolence. Therefore, advise patients about the risks of driving or operating machinery during therapy and to avoid the use of medications or substances (e.g., ethanol ingestion) that may also cause drowsiness. Consider therapy interruption or a dose reduction in patients with multiple myeloma who develop somnolence.
Thalidomide may cause dizziness and orthostatic hypotension; advise patients to sit upright for a few minutes before standing up from a lying or seated position to lower the risk of these side effects.
Hematologic toxicity (e.g., neutropenia and thrombocytopenia) has been reported with thalidomide use. Do not start therapy in patients who have an absolute neutrophil count (ANC) of less than 750 cells/mm3. Monitor complete blood counts (including a differential and platelet counts) at baseline and periodically during therapy, especially in patients predisposed to neutropenia (e.g., HIV-seropositive patients). If the ANC is decreased to less than 750 cells/mm3 during therapy, re-evaluate and consider holding thalidomide therapy if the neutropenia persists. Observe patients for signs and symptoms of bleeding including petechiae, epistaxis, and GI bleeding; patients receiving concomitant medications that may also cause bleeding may be at increased risk for serious bleeding. If grade 3 or 4 thrombocytopenia occurs, consider therapy interruption, a dose reduction, or therapy discontinuation.
Thalidomide use has been associated with an increase in HIV-RNA levels in human immunodeficiency virus (HIV) infection-seropositive patients in controlled trials. The clinical significance of this increase is unknown and appears to be a transient effect. These studies were performed prior to the availability of effective combination antiretroviral therapy. In HIV-seropositive patients, it is recommended to monitor viral load after the first and third months of thalidomide treatment and every 3 months thereafter.
Seizures have been reported in patients who received thalidomide; most patients had disorders that predisposed them to seizure activity. It is unknown whether thalidomide has any epileptogenic influence. Closely monitor patients with a history of seizure disorder or with risk factors for developing seizures for clinical changes that could precipitate acute seizure activity.
Females of reproductive potential should avoid contact with thalidomide capsules; however, there is no specific data available regarding the reproductive risks of accidental exposure (e.g., cutaneous absorption or inhalation of thalidomide). Healthcare providers or other caregivers who are exposed to body fluids from patients receiving thalidomide should wash the affected area with soap and water. Advise anyone administering thalidomide capsules to take appropriate precautions (e.g., wear gloves) to avoid cutaneous exposure.
Advise male and female patients to avoid blood donation during thalidomide therapy, including during therapy interruption, and for 4 weeks after the last thalidomide dose due to the risk of fetal exposure and birth defects if a pregnant woman is administered donated blood.
The use of a PD-1 or PDL1 blocking antibody with a thalidomide analogue plus dexamethasone is not recommended for multiple myeloma treatment outside of a clinical trial. Two clinical trials were halted due to an increased risk of death in patients who received pembrolizumab and dexamethasone in combination with an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of multiple myeloma.
Monitor patients at risk for tumor lysis syndrome (TLS) (e.g., high tumor burden prior to treatment). Take precautionary measures (e.g., hydration, uric acid lowering therapy) as appropriate in these patients.
Bradycardia has been reported with thalidomide use. Use thalidomide and other medications that decrease heart rate together with caution as concomitant use may result in an additive risk for bradycardia. Monitor all patients for signs and symptoms of bradycardia and syncope. Therapy interruption or discontinuation may be necessary in patients who develop bradycardia.
Adverse events including atrial fibrillation, constipation, fatigue, nausea, hypokalemia, deep venous thrombosis, hyperglycemia, pulmonary embolism, and asthenia occurred more often in geriatric patients 65 years and older with multiple myeloma who received thalidomide compared with younger patients in a clinical study.
Thalidomide is contraindicated for use during pregnancy. Thalidomide is a known human teratogen and even a single dose taken by a pregnant woman may cause severe birth defects. Severe and life-threatening birth defects such as amelia; phocomelia; hypoplasticity of the bones; absence of bones; external ear abnormalities; facial palsy; eye abnormalities; congenital heart defects; alimentary tract, urinary tract, and genital malformations; and death at or shortly after birth have been reported in human infants. It may cause birth defects or intrauterine fetal death if administered during pregnancy. In order to prevent fetal exposure, thalidomide is only available through a restricted distribution program, the THALOMID REMS program. This program requires prescribers, pharmacists, and patients to comply with certain conditions prior to prescribing, dispensing, or receiving thalidomide. It can be prescribed only by licensed prescribers who are registered in the THALOMID REMS program and understand the potential risk of teratogenicity if used during pregnancy. If pregnancy does occur during treatment, immediately discontinue thalidomide. Prescribers are encouraged to report all cases of suspected fetal exposure to Celgene Corporation at 1-888-423-5436 or to the FDA MedWatch program at 1-800-332-1088. Refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Counsel patients about the reproductive risk and contraception requirements during thalidomide treatment. Do not initiate therapy in females of reproductive potential until pregnancy testing is performed twice with confirmed negative results. Administer the first test within 10 to 14 days and the second test 24 hours prior to prescribing thalidomide. Once treatment is started, continue pregnancy testing weekly during the first 4 weeks of treatment, then every 4 weeks in females with regular menstrual cycles and every 2 weeks in females with irregular menstrual cycles. Effective contraception must be used by all females of reproductive potential for at least 4 weeks before beginning treatment, during therapy and dosage interruptions, and for 4 weeks following discontinuation of therapy. Women must commit to abstain continuously from heterosexual sexual intercourse or use 2 methods of reliable birth control, including at least 1 highly effective method (e.g., intrauterine device (IUD), hormonal contraception, tubal ligation, or partner's vasectomy) and 1 additional effective method (e.g., latex condom, diaphragm, or cervical cap). Follow these contraceptive requirements even in patients with a history of fertility problems, unless a hysterectomy has been performed. Discontinue treatment, test for pregnancy, and counsel any woman of reproductive potential who experiences menstrual irregularity (e.g., dysfunctional uterine bleeding) or misses her period. Advise patients that if her doctor is not available, she can call 1-888-423-5436 for information. Thalidomide passes into semen and there is potential for male-mediated teratogenicity. Male patients must use barrier contraception (latex condom) during sexual intercourse with a woman of reproductive potential while on therapy, during interruptions, and for 4 weeks after discontinuing therapy, even if he has undergone a successful vasectomy. Male patients should be warned against sperm donation during thalidomide therapy and for 4 weeks after stopping therapy. Infertility may occur in males based on data from animal studies.
It is not known if thalidomide is secreted in human milk or if it has effects on the breast-fed infant or on milk production. Due to the risk of serious adverse reactions in nursing infants, women should discontinue breast-feeding during thalidomide therapy.
For the treatment of erythema nodosum leprosum (ENL):
NOTE: The FDA has designated thalidomide as an orphan drug for the treatment of erythema nodosum leprosum.
-for the acute treatment of the cutaneous manifestations of moderate to severe erythema ENL:
Oral dosage:
Children 12 years of age, Adolescents, and Adults: 100 to 300 mg orally once daily is the usual initial dosage range; administration at bedtime and at least 1 hour after the evening meal is recommended. Concomitant corticosteroid therapy should be given in patients with moderate to severe neuritis associated with a severe ENL reaction; taper steroids after the neuritis resolves. Start thalidomide at the lower end of the dosing range in patients weighing less than 50 kg. Patients who have a severe cutaneous ENL reaction or who have previously required higher doses to control the reaction may start thalidomide at 400 mg/day orally; the daily dose may be taken at bedtime or in divided doses. Therapy is usually continued at least 2 weeks or until signs and symptoms of active reaction resolve. After treatment, taper therapy by decreasing the thalidomide dose by 50 mg every 2 to 4 weeks. Consider therapy interruption, a dose reduction, or therapy discontinuation in patients who develop grade 3 or 4 adverse reactions.
-as maintenance therapy for the prevention and suppression of the cutaneous manifestations of recurrent ENL:
Oral dosage:
Children 12 years of age, Adolescents, and Adults: Use the minimum dose necessary to control the cutaneous ENL reaction in patients who require maintenance therapy or who flare when thalidomide was tapered after an acute cutaneous reaction. Every 3 to 6 months, attempt to taper therapy by decreasing the thalidomide dose by 50 mg every 2 to 4 weeks. Consider therapy interruption, a dose reduction, or therapy discontinuation in patients who develop grade 3 or 4 adverse reactions.
For the treatment of multiple myeloma:
NOTE: The FDA has designated thalidomide as an orphan drug for the treatment of multiple myeloma.
-for newly diagnosed multiple myeloma, in combination with dexamethasone:
Oral dosage:
Adults: 200 mg orally once daily in combination with dexamethasone 40 mg orally on days 1 to 4, 9 to 12, and 17 to 20; administration at bedtime and at least 1 hour after the evening meal is recommended. Treatment cycles are repeated every 28 days. Consider therapy interruption, a dose reduction, or therapy discontinuation in patients who develop grade 3 or 4 adverse reactions.
-for newly diagnosed multiple myeloma, in combination with Total Therapy 2 regimen*:
Oral dosage:
Adults and Elderly patients 75 years or younger: 400 mg/day PO during induction chemotherapy (withheld on day 5 of cycle 3 during peripheral blood stem-cell collection), thalidomide 100 mg/day PO after each transplant (when platelet count greater than 50,000/mm3), thalidomide 200 mg/day during consolidation therapy, and maintenance therapy with thalidomide 100 mg/day for 1 year and then thalidomide 50 mg every other day until relapse or unacceptable toxicity. Concurrent thalidomide administration was studied as part of the Total Therapy 2 regimen in combination with 4 cycles of induction chemotherapy, 2 (tandem) autologous stem-cell transplants, and 4 cycles of consolidation therapy. Supportive medications included filgrastim, prophylactic antibiotics, histamine H2 blockers, and erythropoietin (as necessary); low molecular weight heparin was given as thromboprophylaxis.
-for newly diagnosed multiple myeloma in elderly or transplant ineligible patients, in combination with melphalan and prednisone*:
Oral dosage:
Elderly patients: The optimal dosage of thalidomide plus melphalan and prednisone has not been clearly established and dosages have varied in randomized controlled trials. Thalidomide 200 mg/day PO for 2 to 4 weeks escalated up to a maximum dose of 400 mg/day if no severe adverse events occurred (median therapy duration of 11 months) plus melphalan 0.25 mg/kg daily for 4 days and prednisone 2 mg/kg daily for 4 days repeated every 6 weeks for 12 cycles was studied in previously untreated patients with multiple myeloma who were between 65 and 75 years of age in one study. Thalidomide was stopped after day 4 of the last cycle. Most patients in this study took a thalidomide dose of 200 mg/day or less. In another study, patients aged 75 years and older received thalidomide 100 mg/day PO at bedtime (median therapy duration of 13.5 months) plus melphalan 0.2 mg/kg daily for 4 days and prednisone 2 mg/kg daily for 4 days repeated every 6 weeks for 12 cycles.
-for newly diagnosed multiple myeloma as induction therapy prior to autologous stem-cell transplantation, in combination with bortezomib and dexamethasone*:
Oral dosage:
Adults <= 65 years: 100 mg PO daily for the first 14 days (cycle 1 only) then 200 mg PO daily thereafter plus bortezomib 1.3 mg/m2 IV on days 1, 4, 8, and 11 and dexamethasone 40 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 (VTD regimen) repeated every 21 days for 3 cycles prior to a double (tandem) autologous stem-cell transplant (ASCT) was studied in a multicenter, randomized, phase III study. Patients randomized to induction therapy with VTD also received two 35-day consolidation cycles with VTD (bortezomib 1.3 mg/m2 IV on days 1, 8, 15, and 22 plus thalidomide 100 mg PO daily and dexamethasone 40 mg on days 1, 2, 8, 9, 15, 16, 22, and 23) following the second transplantation. Patients also received maintenance therapy with dexamethasone 40 mg PO on days 1 to 4 every 28 days until relapse or disease progression. Additionally, thalidomide 200 mg PO daily (dose escalation as follows in the first cycle: 50 mg/day on days 1 to 14 and 100 mg/day on days 15 to 28) plus bortezomib 1.3 mg/m2 IV on days 1, 4, 8, and 11 and dexamethasone 40 mg on days 1 to 4 and 9 to 12 repeated every 4 weeks for 6 cycles prior to an ASCT was studied in another randomized, phase III study. In this study, patients who received up to 3 years of maintenance therapy (starting 3 months after ASCT) with thalidomide (100 mg/day) plus bortezomib (1.3 mg/m2 IV on days 1, 4, 8, and 11 repeated every 3 months) had significantly improved 2-year progression-free survival compared with thalidomide or interferon alfa-2b maintenance therapy.
-for relapsed or refractory multiple myeloma, in combination with dexamethasone*:
NOTE: Thalidomide has been designated an orphan drug by the FDA for this indication.
Oral dosage:
Adults: Multiple regimens have been studied. Thalidomide 100 mg/day PO plus dexamethasone 40 mg/day PO on days 1 to 4 repeated monthly (median time to max response, 4 months; duration of therapy range, 4 to 36 months); and, thalidomide 200 mg/day PO at bedtime (increased by 100 mg every 7 days to a max dose of 600 mg/day) plus dexamethasone 20 mg/m2/day PO for 5 days repeated every 15 days followed by thalidomide 100 to 150 mg/day continuously plus dexamethasone for 5 consecutive days/month were administered in responding patients (median time to remission, 2 months; mean dose at 2 months, 270 mg/day) have been studied in clinical trials.
-for the treatment of newly diagnosed multiple myeloma as induction and consolidation therapy in patients who are eligible for autologous stem-cell transplant, in combination with daratumumab, bortezomib, and dexamethasone*:
Oral dosage:
Adults 65 years and younger: 100 mg orally daily as continuous therapy in combination with daratumumab, bortezomib, and dexamethasone was evaluated in a multicenter, randomized, phase 3 trial (n = 1,085; the CASSIOPEIA trial). In this trial, thalidomide was administered with up to four 28-day induction therapy cycles and two 28-day consolidation therapy cycles of daratumumab (16 mg/kg IV weekly in induction cycles 1 and 2; 16 mg/kg IV every 2 weeks in induction cycles 3 and 4 and for both consolidation cycles), bortezomib (1.3 mg/m2 subcutaneously on days 1, 4, 8, and 11 in each induction and consolidation cycle), and dexamethasone (40 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, and 23 in induction cycles 1 and 2; 40 mg PO/IV on days 1 and 2 and 20 mg PO/IV on days 8, 9, 15, and 16 in induction cycles 3 and 4; and 20 mg PO/IV on days 1, 2, 8, 9, 15, and 16 for both consolidation cycles). Consolidation therapy was begun after hematopoietic reconstitution but not earlier than 30 days after transplant.
For the treatment of AIDS-associated wasting syndrome* and cancer cachexia*:
NOTE: Thalidomide has been designated an orphan drug by the FDA for this indication.
Oral dosage:
Adults: Thalidomide 100 mg PO once daily at bedtime is the typical dose with a range of 50 to 200 mg/day PO. In patients with AIDS-associated wasting syndrome, thalidomide has shown to increase lean body mass 10.5% from baseline after 24 weeks of treatment. Weight gain has continued with continued treatment with thalidomide.
For the treatment of recurrent aphthous ulcer* and stomatitis* in severely immunocompromised patients:
NOTE: Thalidomide has been designated an orphan drug by the FDA for this indication.
Oral dosage:
Adults: Thalidomide 100 to 200 mg PO once daily at bedtime has been studied. If the patient does not respond to lower doses, thalidomide may be increased to 400 to 600 mg/day PO. In patients with HIV-related aphthous ulcers, more than 90% of patients experienced healing of ulcers, decreased pain, improved appetite and increased sense of well-being following 7 to 28 days of treatment with thalidomide. Once the ulcers have healed thalidomide is usually discontinued. Retreatment with thalidomide if the ulcers recur is effective.
For the treatment of chronic graft-versus-host-disease (GVHD)* in combination with steroids and either cyclosporine or tacrolimus:
NOTE: Thalidomide has been designated an orphan drug by the FDA for this indication.
Oral dosage:
Adults and Adolescents: Dosage for this indication not established. 200 mg PO once daily, gradually increased to a target dose of 200 mg PO 4 times daily has been studied. Drug discontinuation due to intolerance in the thalidomide group was high (>90%). Thalidomide has been given in combination with prednisone and a calcineurin inhibitor (cyclosporine or tacrolimus).
Children: Dosage for this indication not established. 3 mg/kg PO once daily (if patient less than 67 kg), gradually increased to a target dose of 3 mg/kg PO 4 times daily has been studied. Drug discontinuation due to intolerance in the thalidomide group was high (>90%). Thalidomide has been given in combination with prednisone and a calcineurin inhibitor (cyclosporine or tacrolimus).
For the treatment of AIDS-related Kaposi's sarcoma*:
NOTE: Thalidomide has been designated an orphan drug by the FDA for this indication.
Oral dosage:
Adults: 200 mg/day PO escalated by 200 mg/day every 2 weeks as tolerated to a maximum of 1,000 mg/day was given to patients for 52 weeks in a phase II study of 20 male patients; the overall response rate was 47%.
For the treatment of primary malignant glioma* (including astrocytoma*):
NOTE: Thalidomide has been designated an orphan drug by the FDA for this indication.
-for the treatment of recurrent primary malignant glioma*, including astrocytoma* as a single-agent:
Oral dosage:
Adults: 800 to 1,200 mg PO per day has been studied. In a phase II study of single-agent thalidomide in recurrent high-grade gliomas, results showed an ORR of 6%, median TTP = 10 weeks and median OS = 28 weeks, leading authors to conclude that single-agent thalidomide was not effective. Toxicities included seizures, constipation, neuropathy and somnolence.
-for the treatment of primary malignant glioma, including astrocytoma in combination with chemotherapy or radiation therapy*:
Oral dosage:
Adults: Thalidomide has been used in combination with various chemotherapy agents and/or radiation therapy. In a phase II trial, thalidomide 800 to 1,200 mg PO per day was given with carmustine 200 mg/m2 intravenously every 6 weeks. Alternately, a starting dose of thalidomide 100 mg PO per day (escalated by 100 mg PO per day up to a dose of 400 mg PO per day) was given with irinotecan 350 to 700 mg/m2 (depending on anti-epileptic regimen). Additionally, temozolomide 150 to 200 mg/m2/day PO on days 1 to 5 every 28 days plus radiation therapy (6 weeks) was given in combination with thalidomide 200 mg PO per day (beginning on day 7) dose escalated by 100 to 200 mg PO per day every 7 to 14 days to a maximum dose of 1,200 mg PO per day.
For the treatment of myelodysplastic syndrome (MDS)*:
Oral dosage:
Adults: As a single agent, thalidomide 100 mg/day PO escalated to 400 mg/day PO was used in one trial. Of the 51 evaluable patients, 31% responded to therapy including some patients becoming transfusion independent. No cytogenetic or complete responses were seen, but some patients showed hematologic improvement. Patients who responded had lower baseline blast counts, shorter duration of pretherapy platelet transfusions, and higher platelet counts.
For the treatment of discoid lupus erythematosus*, subacute cutaneous lupus erythematosus*, chronic cutaneous lupus erythematosus*, and the cutaneous manifestations of systemic lupus erythematosus (SLE)*:
Oral dosage:
Adults: In patients who are refractory to previous treatment, initial doses of thalidomide of 50 to 400 mg/day PO until clinical response is achieved have been given. Doses are gradually tapered and maintained at 25 to 100 mg PO once daily. Retreatment for relapse with thalidomide 25 to 100 mg/day PO is usually effective.
For the treatment of Behcet's syndrome*:
Oral dosage:
Adults: Thalidomide 100 to 400 mg/day PO daily for up to 38 months has been effective in improving arthritis, ocular manifestations and skin lesions associated with Behcet's syndrome.
For the treatment of prurigo*, specifically, prurigo nodularis*:
Oral dosage:
Adults: Thalidomide 50 to 300 mg/day PO for an average duration of 12 months produced immediate and pronounced relief of intense pruritus and a significant decrease in the number of skin lesions.
For the treatment of refractory Crohn's disease*:
NOTE: Thalidomide has been designated an orphan drug by the FDA for this indication.
Oral dosage:
Adults: Safety and efficacy not established. Various treatment regimens have been described in the literature, in the range of 50 mg to 300 mg/day PO. Reserve for induction therapy in patients refractory to guideline recommended therapies. Due to side effects and teratogenic potential, as well as lack of evidence for maintenance of remission, thalidomide is not included in current guidelines for the induction or maintenance management of Crohn's disease in adults.
For the treatment of peripheral T-cell lymphoma (PTCL)*:
-for the first-line treatment of PTCL in combination with gemcitabine, cisplatin, and prednisone*:
Oral dosage:
Adults and Adolescents 14 years and older: 200 mg orally daily in combination with gemcitabine (800 mg/m2 IV over 30 minutes on days 1 and 8), cisplatin (25 mg/m2 IV on days 1, 2, and 3), and prednisone (60 mg/m2 PO on days 1, 2, 3, 4, and 5) was evaluated in patients with previously untreated PTCL in a randomized trial. Cycles of therapy were repeated every 21 days until disease progression or for up to 6 cycles. Thalidomide was initiated at 50 mg/day and increased in 50-mg increments daily until 200 mg/day. Patients received aspirin 100 mg/day PO during thalidomide therapy. The use of granulocyte colony-stimulation factor was permitted as indicated.
Therapeutic Drug Monitoring:
Maximum Dosage Limits:
-Adults
Multiple myeloma: 200 mg/day PO.
Erythema nodosum leprosum: 400 mg/day PO.
-Geriatric
Multiple myeloma: 200 mg/day PO.
Erythema nodosum leprosum: 400 mg/day PO.
-Adolescents
Erythema nodosum leprosum: 400 mg/day PO.
-Children
12 years of age: Erythema nodosum leprosum, 400 mg/day PO.
1 to 11 years: Safety and efficacy not established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Acebutolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Acetaminophen; Aspirin; Diphenhydramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Caffeine; Dihydrocodeine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Acetaminophen; Caffeine; Pyrilamine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Chlorpheniramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Chlorpheniramine; Dextromethorphan: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Chlorpheniramine; Phenylephrine : (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Codeine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Acetaminophen; Dextromethorphan; Doxylamine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Diphenhydramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acetaminophen; Hydrocodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Acetaminophen; Oxycodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Acetaminophen; Pamabrom; Pyrilamine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Acrivastine; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Alfentanil: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Alpha-blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Alprazolam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Amiodarone: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as amiodarone should be used cautiously due to the potential for additive effects.
Amitriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Amlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Atorvastatin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Benazepril: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Celecoxib: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Olmesartan: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Valsartan: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amobarbital: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Anxiolytics; Sedatives; and Hypnotics: (Major) The use of anxiolytics, sedatives, or hypnotics concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Aspirin, ASA; Butalbital; Caffeine: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Aspirin, ASA; Caffeine; Orphenadrine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Aspirin, ASA; Carisoprodol; Codeine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression. (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Aspirin, ASA; Oxycodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Atenolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Atenolol; Chlorthalidone: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Azelastine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Azelastine; Fluticasone: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Baclofen: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Barbiturates: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Belladonna; Opium: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Benzhydrocodone; Acetaminophen: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Benzodiazepines: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Beta-blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Betaxolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as metronidazole should be used cautiously due to the potential for additive effects.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as metronidazole should be used cautiously due to the potential for additive effects.
Bisoprolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Bortezomib: (Moderate) Monitor patients for the development of peripheral neuropathy when receiving bortezomib in combination with other drugs that can cause peripheral neuropathy like thalidomide; the risk of peripheral neuropathy may be additive.
Brimonidine; Timolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Brompheniramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Brompheniramine; Dextromethorphan; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Brompheniramine; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Brompheniramine; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Brompheniramine; Pseudoephedrine; Dextromethorphan: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Buspirone: (Major) Avoid the concomitant use of thalidomide with anxiolytics, sedatives, and hypnotics due to the potential for additive sedative effects.
Butalbital; Acetaminophen: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Butalbital; Acetaminophen; Caffeine: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Butalbital; Acetaminophen; Caffeine; Codeine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression. (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Butalbital; Aspirin; Caffeine; Codeine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression. (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Butorphanol: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as butorphanol due to the potential for additive sedative effects.
Butyrophenone: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Calcium-channel blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Cannabidiol: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cannabidiol and thalidomide. CNS depressants can potentiate the effects of cannabidiol.
Capsaicin; Metaxalone: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Carbidopa; Levodopa; Entacapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Carbinoxamine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Carisoprodol: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Carteolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Carvedilol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Celecoxib; Tramadol: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Cenobamate: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cenobamate and thalidomide. Concurrent use may result in additive CNS depression.
Cetirizine: (Moderate) Concurrent use of cetirizine/levocetirizine with thalidomide should generally be avoided. Coadministration may increase the risk of CNS depressant-related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence.
Cetirizine; Pseudoephedrine: (Moderate) Concurrent use of cetirizine/levocetirizine with thalidomide should generally be avoided. Coadministration may increase the risk of CNS depressant-related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence.
Chlophedianol; Dexbrompheniramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlophedianol; Dexchlorpheniramine; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorcyclizine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlordiazepoxide: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Chlordiazepoxide; Amitriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia. (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Chlordiazepoxide; Clidinium: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Chlorpheniramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Codeine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression. (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Dextromethorphan: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Dextromethorphan; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Hydrocodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression. (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpheniramine; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorpromazine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Chlorzoxazone: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Cimetidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Cisplatin: (Moderate) Monitor for peripheral neuropathy if coadministration of thalidomide and cisplatin is necessary. Both drugs can cause peripheral neuropathy, which may be additive.
Clemastine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Clevidipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Clomipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Clonazepam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Clorazepate: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Clozapine: (Major) It is unclear if concurrent use of other drugs known to cause neutropenia (e.g., antineoplastic agents) increases the risk or severity of clozapine-induced neutropenia. Because there is no strong rationale for avoiding clozapine in patients treated with these drugs, consider increased absolute neutrophil count (ANC) monitoring and consult the treating oncologist.
Codeine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Codeine; Guaifenesin: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Codeine; Guaifenesin; Pseudoephedrine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Codeine; Phenylephrine; Promethazine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression. (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Codeine; Promethazine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression. (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
COMT inhibitors: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Cyclobenzaprine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Cyproheptadine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Dantrolene: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Darbepoetin Alfa: (Moderate) Monitor for signs and symptoms of thromboembolic events if concomitant use of thalidomide and an erythropoiesis-stimulating agent (ESA) is required. Both medications have been associated with venous thromboembolism and concomitant use may increase the risk of thrombosis.
Denosumab: (Moderate) The safety and efficacy of denosumab use in patients with immunosuppression have not been evaluated. Patients receiving immunosuppressives along with denosumab may be at a greater risk of developing an infection and/or osteonecrosis of the jaw, a rare condition that has been reported during denosumab therapy.
Desipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Desogestrel; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Deutetrabenazine: (Moderate) Concurrent use of deutetrabenazine and drugs that can cause CNS depression, such as thalidomide, may have additive effects and worsen drowsiness or sedation. Advise patients about worsened somnolence and not to drive or perform other tasks requiring mental alertness until they know how deutetrabenazine affects them.
Dexamethasone: (Moderate) Coadministration of dexamethasone with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.
Dexbrompheniramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Dexbrompheniramine; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Dexchlorpheniramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Dextromethorphan; Diphenhydramine; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Diazepam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Dienogest; Estradiol valerate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Difelikefalin: (Moderate) Monitor for dizziness, somnolence, mental status changes, and gait disturbances if concomitant use of difelikefalin with CNS depressants is necessary. Concomitant use may increase the risk for these adverse reactions.
Digoxin: (Moderate) Thalidomide and digoxin should be used cautiously due to the potential for additive bradycardia. The pharmacokinetic parameters of thalidomide and digoxin were not affected when a single dose of digoxin 0.5 mg was administered in 16 healthy men who were receiving thalidomide 200 mg/day (at steady state levels).
Diltiazem: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Dimenhydrinate: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Diphenhydramine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Diphenhydramine; Ibuprofen: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Diphenhydramine; Naproxen: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Diphenhydramine; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Disulfiram: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as disulfiram should be used cautiously due to the potential for additive effects.
Docetaxel: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as docetaxel should be used cautiously due to the potential for additive effects.
Dorzolamide; Timolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Doxazosin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Doxepin: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Doxylamine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Doxylamine; Pyridoxine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Droperidol: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Drospirenone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Estetrol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Ethinyl Estradiol; Levomefolate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Elagolix; Estradiol; Norethindrone acetate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Entacapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Epoetin Alfa: (Moderate) Monitor for signs and symptoms of thromboembolic events if concomitant use of thalidomide and an erythropoiesis-stimulating agent (ESA) is required. Both medications have been associated with venous thromboembolism and concomitant use may increase the risk of thrombosis.
Erythropoiesis-Stimulating Agents: (Moderate) Monitor for signs and symptoms of thromboembolic events if concomitant use of thalidomide and an erythropoiesis-stimulating agent (ESA) is required. Both medications have been associated with venous thromboembolism and concomitant use may increase the risk of thrombosis.
Esketamine: (Major) Closely monitor patients receiving esketamine and thalidomide for sedation and other CNS depressant effects. Instruct patients who receive a dose of esketamine not to drive or engage in other activities requiring alertness until the next day after a restful sleep.
Esmolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Estazolam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Estradiol; Levonorgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Estradiol; Norethindrone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Estradiol; Norgestimate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Eszopiclone: (Major) The use of anxiolytics, sedatives, or hypnotics concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Ethanol: (Major) Avoid the concomitant use of thalidomide with alcohol due to the potential for additive sedative effects. Additionally, using thalidomide and alcohol together may potentiate the adverse effect of peripheral neuropathy. (Moderate) Avoid the concomitant use of thalidomide with alcohol due to the potential for additive sedative effects. Additionally, using thalidomide and alcohol together may potentiate the adverse effect of peripheral neuropathy.
Ethinyl Estradiol; Norelgestromin: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ethinyl Estradiol; Norethindrone Acetate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ethinyl Estradiol; Norgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ethynodiol Diacetate; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Etonogestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Etonogestrel; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Famotidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Felodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Fenfluramine: (Major) Avoid coadministration of fenfluramine with thalidomide due to the risk of additive CNS depression.
Fenofibric Acid: (Minor) At therapeutic concentrations, fenofibric acid is a weak inhibitor of CYP2C19. Concomitant use of fenofibric acid with CYP2C19 substrates, such as thalidomide, has not been formally studied. Fenofibric acid may theoretically increase plasma concentrations of CYP2C19 substrates and could lead to toxicity for drugs that have a narrow therapeutic range. Monitor the therapeutic effect of thalidomide during coadministration with fenofibric acid.
Fentanyl: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Fluphenazine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Flurazepam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Food: (Major) Advise patients to avoid cannabis use while taking CNS depressants due to the risk for additive CNS depression and potential for other cognitive adverse reactions.
Fosphenytoin: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as phenytoin or fosphenytoin due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and agents that cause peripheral neuropathy such as phenytoin may increase the potential for additive neuropathy.
Gabapentin: (Major) Avoid coadministration of thalidomide with gabapentin because of the risk of additive CNS depression. If concurrent use cannot be avoided, initiate gabapentin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration. Educate patients about the risks and symptoms of excessive CNS depression.
H2-blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Haloperidol: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Homatropine; Hydrocodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Hydrocodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Hydrocodone; Ibuprofen: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Hydromorphone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Hydroxyzine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Ibuprofen; Famotidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Ibuprofen; Oxycodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Imipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Isradipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Labetalol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Lasmiditan: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lasmiditan and thalidomide. Concurrent use may result in additive CNS depression.
Lemborexant: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lemborexant and thalidomide. Dosage adjustments of lemborexant and thalidomide may be necessary when administered together because of potentially additive CNS effects. The risk of next-day impairment, including impaired driving, is increased if lemborexant is taken with other CNS depressants.
Leuprolide; Norethindrone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levamlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Levobunolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Levocetirizine: (Moderate) Concurrent use of cetirizine/levocetirizine with thalidomide should generally be avoided. Coadministration may increase the risk of CNS depressant-related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence.
Levonorgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levonorgestrel; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levorphanol: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Lithium: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as lithium due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as lithium may increase the potential for additive bradycardia.
Lofexidine: (Moderate) Monitor for additive hypotension, bradycardia, and sedation during coadministration of lofexidine and thalidomide. Lofexidine can potentiate the effects of CNS depressants. Patients should be advised to avoid driving or performing any other tasks requiring mental alertness until the effects of the combination are known.
Lorazepam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Loxapine: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Lumateperone: (Moderate) Avoid the concurrent use of thalidomide and lumateperone if possible due to the potential for additive CNS depression. If coadministration is required, monitor for excessive sedation and somnolence.
Lurasidone: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Meclizine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Meperidine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Meprobamate: (Major) The use of anxiolytics, sedatives, or hypnotics concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Metaxalone: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Methadone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Methocarbamol: (Moderate) Thalidomide frequently causes drowsiness and somnolence and may enhance the sedative activity of methocarbamol.
Methohexital: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Methoxy polyethylene glycol-epoetin beta: (Moderate) Monitor for signs and symptoms of thromboembolic events if concomitant use of thalidomide and an erythropoiesis-stimulating agent (ESA) is required. Both medications have been associated with venous thromboembolism and concomitant use may increase the risk of thrombosis.
Metoprolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Metronidazole: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as metronidazole should be used cautiously due to the potential for additive effects.
Midazolam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Molindone: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Morphine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Morphine; Naltrexone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Nabilone: (Major) The use of CNS depressants concomitantly with thalidomide may cause an additive sedative effect and should be avoided.
Nadolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Nalbuphine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as nalbuphine due to the potential for additive sedative effects.
Nebivolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Nebivolol; Valsartan: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Nefazodone: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as nefazodone due to the potential for additive sedative effects.
Nicardipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
NIFEdipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Nimodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Nisoldipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Nizatidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Non-oral combination contraceptives: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norgestimate; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Nortriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Oliceridine: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Opiate Agonists: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Opicapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Oral Contraceptives: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Oritavancin: (Moderate) Thalidomide is metabolized by CYP2C19; oritavancin is a weak CYP2C19 inhibitor. Coadministration may result in elevated thalidomide plasma concentrations. If these drugs are administered concurrently, monitor patients for signs of thalidomide toxicity, such as increased fatigue, drowsiness, or neuropathy.
Orphenadrine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Oxazepam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Oxycodone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Oxymorphone: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Paclitaxel: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as paclitaxel should be used cautiously due to the potential for additive effects.
Pamidronate: (Moderate) In patients with multiple myeloma, the risk of renal dysfunction may be higher in patients taking both pamidronate and thalidomide.
Pentazocine; Naloxone: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as pentazocine due to the potential for additive sedative effects.
Pentobarbital: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Perindopril; Amlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Perphenazine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Perphenazine; Amitriptyline: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects. (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Phenobarbital: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Phenothiazines: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Phenoxybenzamine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Phentolamine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Phenytoin: (Moderate) Avoid the concomitant use of thalidomide with other central nervous system depressants such as phenytoin due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and agents that cause peripheral neuropathy such as phenytoin may increase the potential for additive neuropathy.
Pimozide: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Pindolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Pramipexole: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as pramipexole due to the potential for additive sedative effects.
Prazosin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Pregabalin: (Major) Avoid coadministration of thalidomide with pregabalin because of the risk of additive CNS depression. If concurrent use cannot be avoided, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration. Educate patients about the risks and symptoms of excessive CNS depression.
Primidone: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Prochlorperazine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Promethazine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Promethazine; Dextromethorphan: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Promethazine; Phenylephrine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Propranolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Protriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Pseudoephedrine; Triprolidine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Quazepam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Ramelteon: (Major) Avoid the concomitant use of thalidomide with anxiolytics, sedatives, and hypnotics due to the potential for additive sedative effects.
Ranitidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Relugolix; Estradiol; Norethindrone acetate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Remifentanil: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Remimazolam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Ropinirole: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as ropinirole due to the potential for additive sedative effects.
Secobarbital: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Sedating H1-blockers: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Segesterone Acetate; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Skeletal Muscle Relaxants: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Sotalol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Stiripentol: (Moderate) Monitor for excessive sedation and somnolence during coadministration of stiripentol and thalidomide. CNS depressants can potentiate the effects of stiripentol.
Succinylcholine: (Moderate) Use succinylcholine with caution in patients taking thalidomide due the risk of additive bradycardia.
Sufentanil: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Tapentadol: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Telmisartan; Amlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Temazepam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Terazosin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Thioridazine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Thiothixene: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Timolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Tizanidine: (Moderate) Thalidomide frequently causes drowsiness and somnolence and may enhance the sedative activity of tizanidine.
Tolcapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Tramadol: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Tramadol; Acetaminophen: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Trandolapril; Verapamil: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Trazodone: (Major) The use of CNS depressants, such as trazodone, concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Triazolam: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Trifluoperazine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Trimipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Triprolidine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Verapamil: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Vincristine Liposomal: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as vincristine should be used cautiously due to the potential for additive effects.
Vincristine: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as vincristine should be used cautiously due to the potential for additive effects.
Zaleplon: (Major) The use of anxiolytics, sedatives, or hypnotics concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Zoledronic Acid: (Moderate) In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Zolpidem: (Major) The use of anxiolytics, sedatives, or hypnotics concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Zuranolone: (Major) Avoid the use of multiple sedating agents due to the risk for additive CNS depression. If use is necessary, consider a downward dosage adjustment of either or both medications, especially in patients with additional risk factors for sedation-related harm.
The complete mechanism of action of thalidomide is not completely understood. In vitro and in vivo studies show that thalidomide selectively reduces levels of tumor necrosis factor alpha (TNF-alpha) by accelerating the degradation of TNF-alpha messenger RNA (mRNA) encoding protein. Thalidomide reduces the half-life of the TNF-alpha mRNA encoding protein from 30 minutes to about 17 minutes. Thalidomide does not affect mRNA levels of interleukin (IL)-1 or IL-6. TNF-alpha has been associated with the pathology and symptoms of many different diseases including ENL, AIDS, cancers, graft-versus-host disease, tuberculosis and malaria. Symptoms associated with TNF-alpha include fever, weight loss and characteristics of septic shock resulting in endothelial damage, disturbances of lipid metabolism and release of IL-1. The mechanism of thalidomide is different from the proposed mechanism of pentoxifylline or corticosteroids, which suppress lipopolysaccharide-induced TNF-alpha RNA transcription and translation, respectively. Thalidomide also increases levels of IL-2 and interferon-gamma, augment NK-like activity, and inhibit IL-12 production. Recently, thalidomide has been recognized as an inhibitor of angiogenesis due to inhibition of basic fibroblast growth factor (bFGF). bFGF has been shown to stimulate limb growth and its inhibition may be the basis for the limb defects associated with thalidomide.
Thalidomide is administered orally. It is 55-66% protein bound. Thalidomide appears to undergo non-enzymatic hydrolysis in the plasma followed by urinary excretion. Approximately 94% of the radioactivity was recovered at day 8 following a single 400-mg oral dose of 14C-thalidomide; most of the radioactivity was excreted within 48 hours. About 92% of the radioactive dose was excreted in the urine, primarily as hydrolytic metabolites; less than 3.5% of the dose was excreted as unchanged thalidomide. Fecal excretion accounted for less than 2% of the radioactive dose. The half-life ranged from 5.5-7.3 hours in healthy subjects (n = 14) and patients with Hansen's disease (n = 6) who received a single dose of thalidomide (50-400 mg).
Affected cytochrome P450 isoenzymes: none at therapeutic concentrations
Thalidomide undergoes insignificant metabolism by human CYP450 isoenzymes at therapeutic concentrations. Therefore, clinically important interactions with other CYP450 substrates, inhibitors, or inducers are not expected.
-Route-Specific Pharmacokinetics
Oral Route
Thalidomide is slowly absorbed from the GI tract. The exact bioavailability has not been determined due to the poor aqueous solubility of thalidomide. Following a single dose of thalidomide 50 mg, 200 mg, or 400 mg, the AUC values ranged from 4.9-36.4 micrograms (mcg) X hr/mL in 14 healthy subjects; the AUC value was 46.4 mcg X hr/mL in 6 patients with Hansen's disease (leprosy) who received a single 400-mg dose of thalidomide. Additionally, the Cmax and Tmax values ranged from 0.62-2.82 mcg/mL and 2.9-4.3 hours, respectively, in healthy subjects; the Cmax and Tmax values were 3.44 mcg/mL and 5.7 hours, respectively, in patients with Hansen's disease. Administering thalidomide with a high-fat meal increased the Tmax to about 6 hours; however, the AUC and Cmax values changed by less than 10%.
-Special Populations
Geriatric
Age (range, 20-69 years) did not affect the pharmacokinetic parameters of thalidomide in an analysis in healthy volunteers and patient with Hansen's disease (leprosy).
Gender Differences
Gender does not affect the pharmacokinetic parameters of thalidomide based on a population analysis.
Obesity
Body weight was found to have a linear correlation with thalidomide clearance in patients with multiple myeloma. Thalidomide clearance ranged from 6-12 L/hour in patients who weighed 47-133 kg; clearance increased by 0.605 L/hour per 10 kg of body weight increase.
Other
Human immunodeficiency virus (HIV)
Thalidomide was detected in the semen of HIV-positive males who received 100 mg/day in a pharmacokinetic study. The pharmacokinetic parameters following a single dose of thalidomide were similar in HIV-positive patients and healthy subjects. The Cmax was 3.47 micrograms (mcg)/mL with a Tmax of 3.4 hours and AUC 40.11 mcg X hr/mL in HIV-positive patients who received thalidomide 300 mg.
Aphthous ulcers and other GI conditions
Patients with aphthous ulcers or other conditions affecting the GI tract may have different pharmacokinetic profiles due to potential differences in absorption.
Store & manage your medication list
Medication pricing updates
Import medication from your pharmacy
Pill & refill reminders
Medication journal & mood log