Corticotropin (ACTH) is a parenteral preparation of adrenocorticotropic hormone (ACTH). Corticotropin is a hormone naturally secreted by cells in the anterior lobe of the pituitary gland; corticotropin for commercial use is a highly purified sterile product extracted from the pituitary glands of pigs. In some situations, cosyntropin, a synthetic polypeptide containing the same first 24-amino acid sequence as natural corticotropin and with less antigenicity, has replaced corticotropin, primarily as an aid in the diagnosis of adrenocortical insufficiency. Corticotropin is indicated for numerous autoimmune, allergic, and inflammatory conditions; however, the corticotropin repository injection is most commonly used in adult patients for multiple sclerosis ; other indications are usually treated with prednisone, methylprednisolone or more commonly used systemic corticosteroids. In pediatric patients, corticotropin is most commonly used for the treatment of infantile spasms infants and children less than 2 years of age. Due to its derivation, the drug is contraindicated in patients with porcine protein hypersensitivity.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-The repository corticotropin gel injection is not for intravenous use; administer by intramuscular or subcutaneous routes only.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
-Repository corticotropin gel injection is a clear, light amber solution.
Intramuscular Administration
Multi-dose vial
-Allow the repository corticotropin gel injection to reach room temperature before administration. Caution should be taken not to over-pressurize the vial prior to withdrawing the product.
-Inject deeply into a large muscle mass. Rotate injection sites.
-Do not use the single-dose prefilled SelfJect injector for intramuscular administration or the treatment of infantile spasms.
Subcutaneous Administration
Multi-dose vial
-Allow the repository corticotropin gel injection to reach room temperature before administration. Take caution not to over-pressurize the vial prior to withdrawing the product.
-Inject subcutaneously. Rotate injection sites.
Single dose prefilled SelfJect Injection
-For subcutaneous use in adults only.
-The SelfJect injector is for doses of either 40 units or 80 units; use the multi-dose vial for administration of any other doses.
-Remove from the refrigerator and sealed tray 45 minutes prior to injection.
-Administer by subcutaneous injection into the upper thigh, abdomen, or back of arm. Avoid injecting within 1 inch of navel, knee, or groin area. Avoid scars, tattoos, warts, birthmarks, stretch marks, or irritated skin.
-Rotate injection sites. Do not use the same site more than 1 time per week.
Administration of corticotropin can produce skin atrophy and thinning (reported in adults only), acne vulgaris, hyperhidrosis (adults only), and facial erythema. In a group of pediatric patients less than 2 years of age treated with corticotropin 150 mg/m2 once daily, 14% of patients developed acne and 8% developed a rash (unspecified). None of the pediatric patients who received the recommended dose of 75 mg/m2 twice daily developed acne or rash. An injection site reaction and abscess may occur and have been reported with postmarketing use of corticotropin. Impaired wound healing, petechiae, ecchymosis, and suppression of skin test reactions may also occur.
Corticotropin (ACTH) therapy may cause gastrointestinal (GI) effects such as diarrhea, nausea, vomiting, constipation, abdominal distension, ulcerative esophagitis (esophageal ulceration), and pancreatitis (reported in adults only). GI effects observed in pediatric patients less than 2 years of age include constipation (5% of those receiving 150 units/m2 once daily but 0% of those receiving 75 units/m2 twice daily), diarrhea (3% for 75 units/m2 twice daily and 14% for 150 units/m2 once daily), and vomiting (3% for 75 units/m2 twice daily and 5% for 150 units/m2 once daily). Corticotropin use may cause GI bleeding and gastric ulcer. There is also an increased risk for GI perforation in patients with certain GI disorders. Signs of GI perforation, such as peritoneal irritation, may be masked by the therapy.
Corticotropin (ACTH) therapy may produce a hypersensitivity reaction even in patients who have not received the drug previously. The reactions usually manifest as skin reactions (pruritus, scarlatiniform exanthema, urticaria), dizziness, nausea/vomiting, and mild pyrexia. In some cases, anaphylaxis (anaphylactic shock, hypotension, respiratory compromise, urticaria, swelling), wheezing, circulatory failure, and death have occurred. Prolonged administration increases the risk of hypersensitivity reactions. Use in patients with sensitivity to porcine protein is contraindicated, and the possibility of sensitivity reactions should be considered during the course of treatment if such symptoms arise.
Corticotropin (ACTH) treatment may increase the risks related to infections with any pathogen, including viral, bacterial, fungal, protozoan or helminthic infections. In pediatric patients less than 2 years of age, infection occurred in 20% receiving 75 units/m2 twice daily and 46% receiving 150 units/m2 once daily. The types of infections that occurred with a frequency of 2% or greater included candidiasis, otitis media, pneumonia, and upper respiratory tract infections. Nasal congestion also occurred in 1% and 5% of pediatric patients less than 2 years of age receiving 75 units/m2 twice daily and 150 units/m2 once daily, respectively. Fever has also been observed in 5 to 8% of pediatric patients less than 2 years of age receiving corticotropin for the treatment of infantile spams. Abscess has been reported with use of corticotropin postmarketing.
Prolonged use of Corticotropin (ACTH) may produce posterior subcapsular cataracts, glaucoma (ocular hypertension) with possible damage to the optic nerves. Treatment may enhance the establishment of secondary ocular infection due to fungi and viruses. Exophthalmos may occur due to the pharmacologic effects of corticotropin.
Corticotropin (ACTH) has mineralocorticoid activity and can cause elevation of blood pressure, sodium retention and fluid retention, and increased excretion of potassium and calcium. Dietary salt restriction and potassium supplementation may be necessary in some patients to reduce fluid retention or treat hypokalemia, respectively. Monitor blood pressure and sodium and potassium levels in treated patients. Hypertension has been observed in 11% of pediatric patients less than 2 years of age who received 75 units/m2 twice daily of corticotropin and 19% of pediatric patients who received 150 units/m2 once daily. Cardiac hypertrophy was also observed in 3% of pediatric patients receiving 75 units/m2 twice daily of corticotropin but did not occur in pediatric patients receiving 150 units/m2 once daily. Hypokalemic metabolic alkalosis has been reported (infants only). Congestive heart failure can also develop in some patients, and necrotizing angitis (vasculitis) (adults only) has also been reported. Fluid retention (including peripheral edema and swelling), atrial fibrillation, and palpitations have been reported with postmarketing use of corticotropin.
Corticotropin (ACTH) therapy can produce mental status changes such as euphoria, emotional lability, depression, insomnia, personality changes, and frank psychosis. The drug can aggravate pre-existing emotional instability or psychotic tendencies. Irritability can also occur, especially in pediatric patients, and was observed in 7% and 19% of pediatric patients less than 2 years of age who received corticotropin 75 units/m2 twice daily and 150 units/m2 once daily, respectively. Insomnia has been reported postmarketing. General asthenic conditions (e.g., fatigue, malaise, asthenia, and lethargy) have been reported with postmarketing use of corticotropin.
Common neurologic side effects reported with corticotropin (ACTH) therapy include headache (adults only), vertigo (adults only), subdural hematoma, intracranial bleeding or hemorrhage (adults only), and reversible brain shrinkage (infants only, usually secondary to hypertension). Subdural effusion may occur due to the pharmacologic actions of the drug. Some patients receiving corticotropin have developed pseudotumor cerebri (increased intracranial pressure) which may cause papilledema. Pseudotumor cerebri occurred most frequently after a dosage reduction or immediately after discontinuation of corticotropin therapy. EEG changes may be noted in some patients. Seizures have occurred in 12% and 3% of pediatric patients less than 2 years of age receiving corticotropin 75 units/m2 twice daily and 150 units/m2 once daily, respectively. It is difficult to determine the causality of corticotropin leading to seizures when it is used in pediatric patients for the treatment of infantile spasms since these patients can sometimes progress to other seizure disorders. Infantile spams may also mask the presence of other types of seizures and once the spasms are treated these other seizures may become visible. Once treated with corticotropin, the infantile spasms symptoms may disappear, but this may allow other seizures to become visible for the first time.
Various endocrine disorders, such as menstrual irregularity, hirsutism, hyperglycemia, decreased carbohydrate tolerance, and weight gain, may occur with prolonged corticotropin (ACTH) therapy. Increased blood glucose has been commonly reported postmarketing. Chronic administration of corticotropin can result in suppression of corticotropin release from the pituitary, leading to hypothalamic-pituitary-adrenal (HPA) suppression. The duration and extent of HPA suppression is highly variable and depends on the dose, frequency and time of administration, and duration of therapy. Unlike the corticosteroids which cause adrenocortical atrophy, corticotropin causes adrenal hyperplasia. Hypercorticism (Cushing's syndrome) can occur with prolonged therapy. Cushingoid symptoms (3% vs. 22%) have been reported in pediatric patients less than 2 years of age receiving corticotropin 75 units/m2 twice daily and 150 units/m2 once daily, respectively. A non-HPA withdrawal syndrome can also occur following abrupt discontinuance of corticosteroid therapy, which appears to be unrelated to adrenocortical insufficiency. This syndrome includes symptoms such as anorexia, lethargy, nausea/vomiting, headache, fever, arthralgia, myalgia, desquamation, weight loss, and hypotension. These effects are believed to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.
Negative nitrogen balance due to protein catabolism and alteration in glucose tolerance may result in loss of muscle mass. Muscle weakness (myasthenia) may occur. Prolonged therapy with corticotropin (ACTH) can decrease bone formation and increase in bone resorption both through an effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. These, together with a decrease in the protein matrix of the bone (secondary to an increase in protein catabolism) and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and to the development of osteopenia or osteoporosis at any age. Bone fractures such as vertebral compression fractures have been reported with corticotropin therapy in infants. Bone fractures of long bones and avascular necrosis of femoral or humoral heads have been reported with corticosteroid therapy in older or debilitated patients. Postmenopausal women, in particular, should be monitored for signs of osteoporosis during corticotropin therapy. Because of retardation of bone growth, children receiving prolonged therapy may have growth inhibition. Growth and physical development of pediatric patients on prolonged therapy should be carefully monitored.
The use of corticotropin is contraindicated in patients with previous hypersensitivity to corticotropin therapy and those with porcine protein hypersensitivity. Prolonged administration of corticotropin may increase the risk of hypersensitivity reactions; consider hypersensitivity if symptoms arise during therapy. Anaphylaxis has been reported with postmarketing use of corticotropin. Limited data suggest the potential for the development of antibodies to corticotropin with chronic administration along with a loss of both endogenous ACTH and corticotropin activity. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to corticotropin should not receive any form of corticotropin. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
Corticotropin repository gel is contraindicated for intravenous administration.
Due to suppression of the immune system, corticotropin should not be used in patients with infection caused by bacteria, viruses, or fungi that is not controlled by antimicrobials, unless it is a life-threatening situation. The use of corticotropin is contraindicated in patients with a systemic fungal infection, ocular herpes infection, or in very young pediatric patients with a suspected congenital infection. The use of corticotropin in patients with herpes simplex ocular infection can increase the risk of corneal perforation. Those patients with latent tuberculosis or a positive tuberculin skin test should be observed closely during therapy with corticotropin; if therapy is prolonged, initiate chemoprophylaxis.
Vaccination with live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticotropin. Killed or inactivated vaccines should be given with caution during therapy with corticotropin because corticotropin inhibits antibody response after vaccination and neurologic reactions may be aggravated.
Corticotropin is contraindicated in patients with uncontrolled hypertension or congestive heart failure and should be used with caution in patients any degree of hypertension or heart failure. Corticotropin should be used cautiously in patients with other types of cardiac disease due to its propensity to cause water retention and hypertension and to lower serum potassium concentrations. Patients may require potassium supplementation while receiving corticotropin.
Since corticotropin stimulates the production of endogenous corticosteroids, the drug should be used with caution in patients with GI disease, including diverticulitis, ulcerative colitis, or intestinal anastomosis due to a risk of perforation. The use of corticotropin is contraindicated in patients with peptic ulcer disease.
The use of corticotropin is contraindicated in patients with scleroderma or in patients that have had recent surgery.
Corticotropin is contraindicated in patients with primary adrenal insufficiency, hypercortisolism, or any condition associated with these disorders. Prolonged therapy with corticotropin causes hypothalamic-pituitary-adrenal (HPA) suppression due to inhibition of corticotropin release from the pituitary. Patients on long-term therapy may require additional doses of corticosteroids when subjected to stress such as illness, infection, surgery, or trauma. Abrupt discontinuation of corticotropin, especially after prolonged therapy, can lead to adrenal insufficiency. Patients should be monitored for symptoms of adrenal insufficiency after corticotropin therapy is discontinued; these symptoms include fatigue, anorexia, weakness, hyperpigmentation, weight loss, hypotension, and abdominal pain. Parents and caregivers of pediatric patients receiving corticotropin for the treatment of infantile spasms should be informed of the possibility of adrenal insufficiency when the drug is discontinued and instructed to monitor for these symptoms. Adrenal insufficiency can be minimized by tapering of the corticotropin dose prior to discontinuation. Glucocorticoids can also cause or aggravate Cushing's syndrome and therefore should be avoided in patients with Cushing's disease.
Corticotropin should be used with extreme caution in patients with certain chronic or comorbid conditions because the drug may exacerbate these conditions. These include behavioral disorders such as psychosis or emotional instability and neurologic diseases such as myasthenia gravis or seizure disorder.
Corticotropin should be used with caution in patients with certain endocrine conditions such as diabetes mellitus and hypothyroidism. Corticotropin may exacerbate diabetes mellitus; diabetic patients may have an increased requirement for insulin or oral hypoglycemics. Monitor patients for hyperglycemia during and for a period of time after corticotropin therapy. Patients with hypothyroidism can have an exaggerated response to corticotropin or exogenous corticosteroids; any corticosteroid should be used with caution in these patients.
Due to the sodium-retaining, fluid-retaining, and potassium-wasting properties of the drug, corticotropin should be used with caution in patients with renal impairment, hypokalemia, hypernatremia, or other patients who may be sensitive to fluid/electrolyte disturbances.
Use corticotropin cautiously in patients with thromboembolic disease because this drug rarely has been reported to increase blood coagulability and to precipitate intravascular thrombosis, thrombophlebitis, and thromboembolism.
Prolonged therapy with corticotropin can cause atrophy of the bone protein matrix due to protein catabolism. This atrophy can cause osteoporosis, fractures, aseptic necrosis of femoral and humoral heads, and pathologic fractures of long bones. Corticotropin is contraindicated in patients with pre-existing osteoporosis. Use cautiously in geriatric, debilitated, and postmenopausal females.
The use of corticotropin (ACTH) is contraindicated in neonates, infants and children less than 2 years of age with a suspected congenital infection. Specific data regarding use of this drug in neonates are not available. Infants and children less than 2 years experience a high rate of infections while receiving corticotropin therapy for infantile spasms; monitor patients carefully for signs and symptoms of infection. Long-term use of corticotropin may have negative effects on growth and physical development in pediatric patients, resulting in growth inhibition. Changes in appetite are seen with corticotropin therapy, with the effects becoming more frequent as the dose or treatment period increases. These effects are reversible once corticotropin use is stopped. Growth and physical development of pediatric patients on prolonged therapy should be carefully monitored.
Corticotropin, ACTH may cause fetal harm when administered to a patient during pregnancy due to stimulation of an endogenous steroid response. Use of corticosteroids during pregnancy has been associated with intrauterine growth restriction, decreased birth weight and preterm birth; thus there is potential concern regarding use of corticotropin in pregnancy. Hypoadrenalism has also been reported in infants born to patients who received high-dose and/or long-term corticosteroid therapy during pregnancy. Corticotropin has not been adequately studied in animals to determine risk of therapy during pregnancy. Closely monitor infants exposed to corticotropin during pregnancy for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting. Adrenocortical disease during pregnancy is relatively rare as most cases are diagnosed before a woman becomes pregnant, but ACTH stimulated normal cortisol values have been established for each trimester. Adrenal disease may cause significant maternal and fetal morbidity, so accurate and rapid diagnosis is important. The use of cosyntropin to confirm the diagnosis of adrenal insufficiency during pregnancy, when suspected, is described in the literature.
There are no available data on the presence of corticotropin, ACTH in human milk, the effects on the breastfed infant, or on milk production. Because many drugs are excreted in human milk and due to the potential for serious adverse reactions in nursing infants, the manufacturer states that a decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of the drug to the mother and the indication for use. However, due to its large molecular weight and short half-life of only 10 to 15 minutes, corticotropin, ACTH is unlikely to appear in human milk. It is also unlikely that corticotropin, ACTH would be absorbed by the infant because it would probably be degraded in the infant's gastrointestinal tract. Animal data suggests an increase in breast milk cortisol levels might be expected after administration of corticotropin to a nursing mother. However, if corticotropin is required in the mother, it is not a reason to discontinue breast-feeding. Alternative therapies to consider include other corticosteroids, such as prednisone and methylprednisolone. Prednisone concentrations in breast milk are low, and no adverse effects have been reported in the breast-fed infant with maternal use of any corticosteroid during breast-feeding; prednisone is generally considered compatible to use during lactation.
For the treatment of infantile spasms:
Intramuscular dosage:
Infants and Children younger than 2 years: 75 units/m2/dose IM twice daily for 2 weeks is the FDA-approved regimen. The dose should then be tapered over a 2-week period to avoid adrenal insufficiency. The FDA-approved product label suggests the following tapering schedule: 30 units/m2/dose IM every morning for 3 days, 15 units/m2/dose IM every morning for 3 days, 10 units/m2/dose IM every morning for 3 days, and 10 units/m2/dose IM every other morning for 6 days. Various other non-FDA-approved regimens have been used off label. Low doses of 5 to 40 units/day IM for 1 to 6 weeks have been recommended by some neurologists, whereas others recommend larger doses of 40 to 160 units/day IM for 3 to 12 months. In 1 study, no major difference in efficacy was found between low doses for short periods and large doses for longer periods of time; however, hypertension was more common with the larger doses. In this study, the low-dose regimen was 20 units/day IM for 2 weeks. If the patient responded, the dose was tapered and discontinued over a 1-week period. If the patient did not respond, the dose was increased to 30 units/day IM for 4 weeks, then tapered and discontinued over a 1-week period. The high-dose regimen was 150 units/m2/day IM for 3 weeks; the dose was then tapered and discontinued over 9 weeks.
For the treatment of acute exacerbations of multiple sclerosis:
Intramuscular or Subcutaneous dosage:
Adults: 80 to 120 units IM or subcutaneously once daily for 2 to 3 weeks. A dose taper may be necessary.
For the adjunctive treatment of an acute episode or exacerbation of rheumatoid arthritis, juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA), or ankylosing spondylitis:
Intramuscular or Subcutaneous dosage:
Adults: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms. Selected cases may require low-dose maintenance therapy.
Children and Adolescents 3 to 17 years: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms. Selected cases may require low-dose maintenance therapy.
For the treatment of symptomatic sarcoidosis:
Intramuscular or Subcutaneous dosage:
Adults: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize dosage based on disease severity and clinical response. A dose taper may be necessary.
Children and Adolescents 3 to 17 years: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize dosage based on disease severity and clinical response. A dose taper may be necessary.
For the treatment of ophthalmic diseases, such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis, choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation:
Intramuscular or Subcutaneous dosage:
Adults: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms.
Children and Adolescents 3 to 17 years: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms.
For the induction of diuresis or remission of proteinuria in the nephrotic syndrome:
Intramuscular or Subcutaneous dosage:
Adults: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms.
Children and Adolescents 3 to 17 years: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms.
For the treatment of dermatologic and allergic states, including severe erythema multiforme, Stevens-Johnson syndrome, or serum sickness, or for collagen diseases such as systemic lupus erythematosus (SLE) or systemic dermatomyositis (polymyositis):
Intramuscular or Subcutaneous dosage:
Adults: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms.
Children and Adolescents 3 to 17 years: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms.
For the adjunctive treatment of an acute episode or exacerbation of psoriatic arthritis (PsA):
Intramuscular or Subcutaneous dosage:
Adults: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms. Guidelines support use for symptomatic relief and acute symptoms.
Children and Adolescents 3 to 17 years: 40 to 80 units IM or subcutaneously every 24 to 72 hours. Individualize the dose and dosing frequency after considering the disease severity, patient response, and plasma and urine corticosteroid concentrations. After prolonged use, a gradual taper may be necessary in order to avoid adrenal insufficiency or recurrent symptoms. Guidelines support use for symptomatic relief and acute symptoms.
Therapeutic Drug Monitoring:
Suppression of the hypothalamic-pituitary-adrenal axis (HPA axis) may occur after prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Monitor patients for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension, and abdominal pain.
Maximum Dosage Limits:
-Adults
80 units/day subcutaneous or IM for most conditions; up to 120 units/day IM for multiple sclerosis exacerbations.
-Geriatric
80 units/day subcutaneous or IM for most conditions; up to 120 units/day IM for multiple sclerosis exacerbations.
-Adolescents
80 units/day subcutaneous or IM.
-Children
2 years and older: 80 units/day subcutaneously or IM.
Less than 2 years: 150 units/m2/day IM.
-Infants
150 units/m2/day IM.
-Neonates
Safety and efficacy have not been 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
Aliskiren; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Amiloride: (Minor) Monitor serum electrolytes, particularly serum calcium concentrations, during concomitant corticotropin and potassium-sparing diuretic use. Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
Amiloride; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss. (Minor) Monitor serum electrolytes, particularly serum calcium concentrations, during concomitant corticotropin and potassium-sparing diuretic use. Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Anthrax Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Atenolol; Chlorthalidone: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Azilsartan; Chlorthalidone: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Bacillus Calmette-Guerin Vaccine, BCG: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Benazepril; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Bumetanide: (Minor) Monitor potassium concentrations during concomitant corticotropin and loop diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and loop diuretics cause increased renal potassium loss.
Calcium Carbonate: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function. Patients taking systemic corticosteroids should ensure proper intake of calcium as directed by their health care provider.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function. Patients taking systemic corticosteroids should ensure proper intake of calcium as directed by their health care provider.
Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function. Patients taking systemic corticosteroids should ensure proper intake of calcium as directed by their health care provider.
Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function. Patients taking systemic corticosteroids should ensure proper intake of calcium as directed by their health care provider.
Calcium Carbonate; Simethicone: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function. Patients taking systemic corticosteroids should ensure proper intake of calcium as directed by their health care provider.
Calcium; Vitamin D: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function. Patients taking systemic corticosteroids should ensure proper intake of calcium as directed by their health care provider.
Candesartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Captopril; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Chikungunya Vaccine, Live: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Chlorothiazide: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Chlorthalidone: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Cholera Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the live cholera vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to cholera bacteria after receiving the vaccine. High-dose corticosteroid therapy may impair immune function and is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days.
Daratumumab; Hyaluronidase: (Minor) Corticosteroids (e.g., cortisone, corticotropin, ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients receiving these medications may require larger amounts of hyaluronidase for equivalent dispersing effect.
Dengue Tetravalent Vaccine, Live: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to the dengue virus vaccine. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine; Inactivated Poliovirus Vaccine, IPV: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV : (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria Toxoid; Tetanus Toxoid Adsorbed, DT, Td: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria/Tetanus Toxoids; Pertussis Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Efgartigimod Alfa; Hyaluronidase: (Minor) Corticosteroids (e.g., cortisone, corticotropin, ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients receiving these medications may require larger amounts of hyaluronidase for equivalent dispersing effect.
Enalapril; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Eprosartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Ethacrynic Acid: (Minor) Monitor potassium concentrations during concomitant corticotropin and loop diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and loop diuretics cause increased renal potassium loss.
Fosinopril; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Furosemide: (Minor) Monitor potassium concentrations during concomitant corticotropin and loop diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and loop diuretics cause increased renal potassium loss.
Gallium Ga 68 Dotatate: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Haemophilus influenzae type b Conjugate Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hepatitis A Vaccine, Inactivated: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hepatitis A Vaccine, Inactivated; Hepatitis B Vaccine, Recombinant: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hepatitis B Vaccine, Recombinant: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Human Papillomavirus 9-Valent Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hyaluronidase, Recombinant; Immune Globulin: (Minor) Corticosteroids (e.g., cortisone, corticotropin, ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients receiving these medications may require larger amounts of hyaluronidase for equivalent dispersing effect.
Hyaluronidase: (Minor) Corticosteroids (e.g., cortisone, corticotropin, ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients receiving these medications may require larger amounts of hyaluronidase for equivalent dispersing effect.
Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Hydrochlorothiazide, HCTZ; Moexipril: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Minor) Use sodium phosphate cautiously with mineralocorticoids as concurrent use can cause hypernatremia in some patients.
Ibritumomab Tiuxetan: (Minor) Use sodium phosphate cautiously with mineralocorticoids as concurrent use can cause hypernatremia in some patients.
Indapamide: (Minor) Monitor potassium concentrations during concomitant corticotropin and indapamide use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and indapamide cause increased renal potassium loss.
Influenza Virus Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Intranasal Influenza Vaccine: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid. (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Irbesartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Japanese Encephalitis Virus Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Lisinopril; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Live Vaccines: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Loop diuretics: (Minor) Monitor potassium concentrations during concomitant corticotropin and loop diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and loop diuretics cause increased renal potassium loss.
Losartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Lutetium Lu 177 dotatate: (Major) Avoid repeated administration of high doses of glucocorticoids during treatment with lutetium Lu 177 dotatate due to the risk of decreased efficacy of lutetium Lu 177 dotatate. Lutetium Lu 177 dotatate binds to somatostatin receptors, with the highest affinity for subtype 2 somatostatin receptors (SSTR2); glucocorticoids can induce down-regulation of SSTR2.
Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Measles/Mumps/Rubella Vaccines, MMR: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Meningococcal Group B Vaccine (3 strain): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Meningococcal Group B Vaccine (4 strain): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Meningococcal Groups A, B, C, W, and Y Vaccine (5 valent): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Meningococcal Groups A, C, W, and Y Vaccine (4 valent): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methenamine; Sodium Acid Phosphate; Methylene Blue; Hyoscyamine: (Minor) Use sodium phosphate cautiously with mineralocorticoids as concurrent use can cause hypernatremia in some patients.
Metolazone: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Metoprolol; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Non-Live Vaccines: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Olmesartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Pertuzumab; Trastuzumab; Hyaluronidase: (Minor) Corticosteroids (e.g., cortisone, corticotropin, ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients receiving these medications may require larger amounts of hyaluronidase for equivalent dispersing effect.
Pneumococcal Vaccine, Polyvalent: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ponesimod: (Moderate) Monitor for signs and symptoms of infection. Additive immune suppression may result from concomitant use of ponesimod and high-dose corticosteroid therapy which may extend the duration or severity of immune suppression. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days.
Potassium Phosphate; Sodium Phosphate: (Minor) Use sodium phosphate cautiously with mineralocorticoids as concurrent use can cause hypernatremia in some patients.
Potassium-sparing diuretics: (Minor) Monitor serum electrolytes, particularly serum calcium concentrations, during concomitant corticotropin and potassium-sparing diuretic use. Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
Quinapril; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Rabies Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Respiratory Syncytial Virus Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Rituximab; Hyaluronidase: (Minor) Corticosteroids (e.g., cortisone, corticotropin, ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients receiving these medications may require larger amounts of hyaluronidase for equivalent dispersing effect.
Rotavirus Vaccine: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
SARS-CoV-2 (COVID-19) vaccines: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) Adenovirus Vector Vaccine: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) mRNA Vaccine: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) Recombinant Spike Protein Nanoparticle Vaccine: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
Smallpox and Monkeypox Vaccine, Live, Nonreplicating: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Smallpox Vaccine, Vaccinia Vaccine: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Sodium Phosphate Monobasic Monohydrate; Sodium Phosphate Dibasic Anhydrous: (Minor) Use sodium phosphate cautiously with mineralocorticoids as concurrent use can cause hypernatremia in some patients.
Spironolactone: (Minor) Monitor serum electrolytes, particularly serum calcium concentrations, during concomitant corticotropin and potassium-sparing diuretic use. Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
Spironolactone; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss. (Minor) Monitor serum electrolytes, particularly serum calcium concentrations, during concomitant corticotropin and potassium-sparing diuretic use. Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
Telmisartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Thiazide diuretics: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Tick-Borne Encephalitis Vaccine: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Torsemide: (Minor) Monitor potassium concentrations during concomitant corticotropin and loop diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and loop diuretics cause increased renal potassium loss.
Trastuzumab; Hyaluronidase: (Minor) Corticosteroids (e.g., cortisone, corticotropin, ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients receiving these medications may require larger amounts of hyaluronidase for equivalent dispersing effect.
Triamterene: (Minor) Monitor serum electrolytes, particularly serum calcium concentrations, during concomitant corticotropin and potassium-sparing diuretic use. Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
Triamterene; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss. (Minor) Monitor serum electrolytes, particularly serum calcium concentrations, during concomitant corticotropin and potassium-sparing diuretic use. Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
Typhoid Vaccine: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Valsartan; Hydrochlorothiazide, HCTZ: (Minor) Monitor potassium concentrations during concomitant corticotropin and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticotropin and thiazide diuretics cause increased renal potassium loss.
Varicella-Zoster Virus Vaccine, Live: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Vincristine Liposomal: (Minor) Use sodium phosphate cautiously with mineralocorticoids as concurrent use can cause hypernatremia in some patients.
Yellow Fever Vaccine, Live: (Contraindicated) Avoid the administration of live virus vaccines with high-dose corticosteroid therapy and for at least 1 month following treatment. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated live virus vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 1 month after discontinuation. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccine efficacy may be diminished in patients receiving any supraphysiologic dose of corticosteroid.
Corticotropin and endogenous ACTH stimulates steroidogenesis and the release of cortisol (hydrocortisone), corticosterone, and weak androgens from the adrenal cortex. The physiologic and pharmacologic effects of corticotropin are due primarily to the glucocorticoid cortisol, which also has some mineralocorticoid activity. Prolonged administration of large doses of corticotropin induces hyperplasia and hypertrophy of the adrenal cortex and continuous high output of cortisol, corticosterone and weak androgens. The release of endogenous ACTH is under the influence of the nervous system via the regulatory hormone released from the hypothalamus and by a negative corticosteroid feedback mechanism. Elevated plasma cortisol suppresses ACTH release. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins; lipocortins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid. Other effects of corticotropin include extra-adrenal effects such as binding to melanocortin receptors.
Although oral glucocorticoids do not depend on adrenal function for effectiveness, have a more predictable profile, and have easily regulated doses for patient-specific therapy, corticotropin therapy is preferred by some clinicians in certain conditions.
The mechanism of action of corticotropin for the treatment of infantile spasms is unknown.
Corticotropin (ACTH) is administered subcutaneously and intramuscularly. Corticotropin is available as a repository corticotropin injection (RCI). ACTH rapidly disappears from the circulation following its intravenous administration; in humans, the plasma half-life is about 15 minutes. The pharmacokinetics of the repository corticotropin injection have not been adequately characterized. The maximal effects of a trophic hormone on a target organ are achieved when optimal amounts of hormone are acting continuously. Thus, a fixed dose of the repository corticotropin injection will demonstrate a linear increase in adrenocortical secretion with increasing duration of an infusion.
Affected cytochrome P450 isoenzymes and drug transporters: None known
-Special Populations
Hepatic Impairment
There is an enhanced effect of corticotropin (ACTH) in patients with cirrhosis of the liver.