Omalizumab is a monoclonal antibody that selectively binds to IgE. Omalizumab is indicated for adult and pediatric patients 6 years and older with moderate to severe persistent asthma that is inadequately controlled despite the use of inhaled corticosteroids (ICS) and who have a positive skin test or in vitro reactivity to a perennial aeroallergen. It is FDA-approved for add on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients. It can also be used as maintenance treatment for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to food in adult and pediatric patients age 1 year and older with IgE-mediated food allergies. Omalizumab is to be used in conjunction with food allergen avoidance. Omalizumab is also FDA-approved for use in patients 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. In clinical trials, the addition of omalizumab to a patient's medication regimen reduced the frequency of allergic asthma exacerbations vs. placebo; more patients treated with omalizumab were able to reduce or discontinue ICS use. GINA supports use of omalizumab in patients 6 years and older with moderate to severe persistent asthma with allergen-driven symptoms uncontrolled with usual therapies. The NAEPP includes add-on omalizumab therapy as a consideration in adult and pediatric patients 5 years and older with moderate to severe persistent asthma despite usual maintenance therapies who meet criteria for use. In clinical trials in patients with CRSwNP, omalizumab had statistically significant improvements on sense of smell, post-nasal drip, and runny nose. In IgE-mediated food allergy, the use of omalizumab was shown to have a statistically higher response rate (68%) vs. placebo (5%) in patients who were able to consume a single dose of 600 mg or more of peanut protein without dose-limiting symptoms. The study also had statistically higher response rates when compared to placebo in patients who were able to consume 1,000 mg or more of peanut, cashew, milk, or egg protein without dose limiting symptoms. In clinical trials involving patients with CSU receiving 300 mg, 150mg, or 75 mg of omalizumab, 36%, 15%, and 12% of patients reported no itch or no hives when compared to placebo (9%). Anaphylactic reactions may develop after the first dose of omalizumab or during ongoing treatment, so patients should be administered each injection by a healthcare professional in a setting equipped to handle anaphylaxis. The use of the drug requires the patient to remain under observation for an appropriate period of time (e.g., 120 minutes) after each injection is given. While administration of omalizumab in a health care setting is preferred, in cases where administration by a health care professional is not possible, temporary self-administration may be considered in select patients with no prior history of anaphylaxis related or unrelated to omalizumab, who have received at least 3 doses of omalizumab, have the ability to recognize and manage signs and symptoms of a severe hypersensitivity reaction (including anaphylaxis), and can perform injections with proper technique and per the prescribed dosing regimen.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
-Omalizumab is administered by subcutaneous injection only.
Subcutaneous Administration
-A healthcare professional should initiate omalizumab treatment in a healthcare setting that is equipped and prepared to identify and treat anaphylaxis until therapy has been safely established. Selection of patients for self-administration should be based on careful assessment of risk for anaphylaxis and mitigation strategies. The following patient specific criteria should be considered:
--For the treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria (CSU): No prior history of anaphylaxis, including omalizumab or other agents, such as foods, drugs, biologics, etc.
-For the treatment of IgE-mediated food allergy: No prior history of anaphylaxis (except foods), including omalizumab, drugs, biologics, etc.
-Receipt of at least 3 doses of omalizumab under the supervision of a healthcare provider with no hypersensitivity reactions
-Patient or caregiver is able to recognize symptoms of a severe hypersensitivity reaction (including anaphylaxis) and treat it appropriately
-Patient or caregiver is able to perform subcutaneous injections with the omalizumab prefilled syringe or autoinjector with proper technique
-Patients 12 years of age and older may self-administer under adult supervision; the autoinjector is not intended for use in patients under the age of 12.
-Observe the patient for an appropriate time after each injection (e.g., up to 120 minutes).
-Instruct the patient to get immediate medical care if signs or symptoms of anaphylaxis or angioedema develop.
Prefilled Syringe Administration
-Omalizumab prefilled syringes are available in 3 dose strengths:
--Omalizumab 75 mg prefilled syringe with a needle shield
-Omalizumab 150 mg prefilled syringe with a needle shield
-Omalizumab 300 mg prefilled syringe with a needle shield
-The prefilled syringe solution should be clear and colorless to pale brownish yellow.
-Determine the number of prefilled syringes that will be needed for the patient's dose. For pediatric patients 6 to 11 years of age, consideration should be given to the number of prefilled syringe injections needed and volume to be injected relative to the patient's bodyweight.
-At least 30 to 45 minutes prior to injection, allow the carton containing the syringe to warm up to room temperature. Keep in the carton to protect it from light. Do not allow the syringe to become hot. Do not speed up the warming process by putting the syringe in the microwave or in warm water.
-Do not open the sealed outer carton until ready to inject. Peel off the blister pack cover. Take the syringe out of the blister pack by holding the middle part of the syringe; do not handle by the needle cap or plunger. Do not take the syringe apart at any time.
--Inspect the syringe closely. The liquid in the syringe should be clear to slightly opalescent and colorless to pale brownish-yellow. Do not use the syringe if the syringe is damaged or expired, or if the liquid is cloudy, discolored, or contains foreign particles.
-Choose an injection site.
--The recommended injection sites are the thigh or abdomen, avoiding the 2-inch area directly around the navel. The outer area of the upper arm may be used only if the injection is given by a caregiver or healthcare provider.
-Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.
-Choose a different injection site for each new injection at least 1 inch from the area used for the last injection.
-Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.
-Hold the syringe firmly with 1 hand and pull the needle cap straight off with your other hand. There may be a small air bubble in the syringe. This is normal; do not try to remove the air bubble. You may also see a drop of liquid at the end of the needle. This is also normal and will not affect the dose.
-Use your other hand and gently pinch the area of skin that was cleaned. Use a quick, dart-like motion to insert the needle all the way into the pinched skin at an angle between 45 degrees to 90 degrees. Do not insert the needle through clothing.
-Once the needle is inserted, slowly inject all the medicine by gently pushing the plunger all the way down to ensure that the full dose gets injected. It may take up to 15 seconds to inject the dose, due to the somewhat viscous nature of the solution.
-Gently release the plunger and allow the needle to be covered by the needle-shield.
-Do not rub the injection site; may cover with a small bandage if needed.
-Disposal: The prefilled syringe is a single-dose syringe and should not be used again. Dispose in an FDA-cleared sharps disposal container right away after use.
Autoinjector Administration
-Omalizumab autoinjectors are available in 3 dose strengths:
--Omalizumab 75 mg autoinjector
-Omalizumab 150 mg autoinjector
-Omalizumab 300 mg autoinjector
-The prefilled syringe solution should be clear and colorless to pale brownish yellow.
-Determine the number of autoinjectors that will be needed for the patient's dose.
-At least 30 to 45 minutes prior to injection, allow the carton containing the syringe to warm up to room temperature. Keep in the carton to protect it from light. Do not allow the syringe to become hot. Do not speed up the warming process by putting the syringe in the microwave or in warm water.
-Do not remove the cap until ready to inject. Take the autoinjector out of the carton. Do not turn the carton upside down to take out the autoinjector. Do not hold the autoinjector by the cap; hold it by the middle.
-Look through the viewing window on the autoinjector. The liquid in the autoinjector should be clear and colorless to pale brownish-yellow. You may notice air bubbles, which is normal. Do not use the syringe if the syringe is damaged or expired, or if the liquid is cloudy or brown, or contains foreign particles.
-Choose an injection site.-The recommended injection sites are the thigh or abdomen, avoiding the 2-inch area directly around the navel. The outer area of the upper arm may be used only if the injection is given by a caregiver or healthcare provider.
-Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.
-Choose a different injection site for each new injection at least 1 inch from the area used for the last injection.
-Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.
-Remove the cap. Hold the autoinjector firmly with 1 hand and pull the cap straight off with your other hand; do not twist the cap. Do not put cap back on the autoinjector; throw away in regular household trash. Do not clean or touch the needle guard of the device.
-Position the autoinjector. Hold the autoinjector comfortably with the needle guard directly against the skin. The autoinjector should be at a 90-degree angle against the skin.
-Start the injection. Press straight down and hold the autoinjector firmly against the skin. It may take up to 15 seconds to inject the dose. The 1st click indicates that the injection has started. Hold the autoinjector tightly in place and do not change the angle of the injection or remove the autoinjector until the injection is completed. The 2nd click indicates that the injection is almost complete. Hold the autoinjector in position until the green indicator has stopped moving and completely fills the viewing window to make sure the injection is complete.
-Remove from the skin and check the green indicator. After the green indicator has stopped moving and has completely filled the viewing window, lift the autoinjector straight up from the skin. The needle guard will automatically extend and lock over the needle. Contact your healthcare provider if the green indicator has not completely filled the viewing window.
-Do not rub the injection site; may cover with a small bandage if needed.
-Disposal: The autoinjector is a single-dose autoinjector and should not be used again. Dispose in an FDA-cleared sharps disposal container right away after use.
Reconstitution of Lyophilized powder vial
-Determine the number of vials that will be needed for the patient's dose.
-Reconstitute each 150-mg vial by injecting 1.4 mL of Sterile Water for Injection into the vial of omalizumab; reconstitution with 0.9% Sodium Chloride injection is NOT recommended due to noted incompatibility.
-Keeping the vial upright, gently swirl for approximately 1 minute to evenly wet the powder. Do NOT shake.
-Allow the vial to stand, and gently swirl the vial for 5 to 10 seconds approximately every 5 minutes to dissolve any remaining solids. Some vials may take longer than 20 minutes to dissolve completely. Do not use if the contents of the vial do not completely dissolve in 40 minutes.
-The reconstituted solution should be clear or slightly opalescent and may have a few small bubbles or foam around the edge of the vial; there should be no visible gel-like or foreign particles in the solution.
-The concentration of the reconstituted solution is 150 mg/1.2 mL (i.e., 125 mg/mL).
-Storage: The reconstituted solution in the vial should be used within 8 hours of reconstitution when stored in the refrigerator (2 to 8 degrees C or 36 to 46 degrees F) or within 4 hours when stored at room temperature. Protect from direct sunlight.
Preparing the dose from the vial
-Invert the vial to allow the solution to drain toward the stopper. Using a new 3 mL syringe equipped with a 1-inch, 18-gauge needle, insert the needle into the inverted vial. Position the needle tip at the very bottom of the solution in the vial stopper when drawing the solution into the syringe. The reconstituted product is somewhat viscous. Withdraw all the product from the vial before expelling any air or excess solution from the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all the solution from the inverted vial.
-Once the solution is in the syringe, replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
-Expel air, large bubbles, and any excess solution in order to obtain a volume of 1.2 mL corresponding to 150 mg dose. To obtain a volume of 0.6 mL (a dose of 75 mg), expel air, large bubbles and discard 0.6 mL from the syringe. A thin layer of small bubbles may remain at the top of the solution in the syringe.
Subcutaneous Administration of reconstituted solution from vial:
-Choose and clean an injection site.
--The recommended injection sites are the upper arm and the front and middle of the thighs.
-Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.
-Choose a different injection site for each new injection at least 1 inch from the area used for the last injection.
-Each subcutaneous injection should not exceed 150 mg per site; doses of more than 150 mg should be divided among 2 or more injection sites.
-Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.
-Inject subcutaneously. The subcutaneous injection may take 5 to 10 seconds to administer due to the viscous solution.
-Dispose used needles and syringes in an FDA-cleared sharps disposal container right away after use.
Injection site reaction was reported in 3% to 45% of adult and pediatric patients using omalizumab during clinical trials. The injection site reactions manifested as bruising, redness (erythema), warmth, burning, stinging, itching, hive formation, pain, induration, mass, bleeding, and inflammation. Severe injection site reactions were reported for 12% of omalizumab treated patients and 9% of control subjects. The majority of the reactions occurred within 1 hour after the injection, lasted less than 8 days, and generally decreased in frequency with subsequent dosing. In healthy adults, the 300 mg/2 mL autoinjector was compared to the 300 mg/2 mL prefilled syringe. Injection site reactions were reported in 24% of patients using the autoinjector compared to 14% of patients using the prefilled syringe.
Arthralgia (3% to 8%) and fever (up to 6.4%) was reported during clinical trials in patient receiving omalizumab. During postmarketing surveillance, a constellation of signs and symptoms have been reported with omalizumab including arthritis/arthralgia, rash or hives, fever, and lymphadenopathy. These symptoms usually occur within 1 to 5 days after the first or subsequent doses of omalizumab and may recur in some patients. Although circulating immune complexes or skin biopsy consistent with a Type III reaction were not noted, these signs and symptoms are similar to serum sickness. Stop therapy if patients present with this constellation of symptoms.
Dermatologic adverse events reported during omalizumab clinical trials include pruritus (2%), dermatitis (2%), and urticaria (2% or more). Urticaria necessitated either the discontinuation of omalizumab or the need for a concomitant medication in 0.2% of pediatric patients 6 to 11 years of age. Additionally, arthropod bite was reported in 3% or more of pediatric patients 6 to 11 years of age. Hair loss (alopecia) was reported in 2% or more of patients during clinical trials and was noted in postmarketing reports.
Infection is possible with the use of omalizumab. Viral infections (23%), upper respiratory tract infections (20%), sinusitis (16%), and pharyngitis (11%) were reported during clinical trial experience in patients with allergic asthma. Infections reported during clinical trial experience in patients 12 years and older with chronic spontaneous urticaria include nasopharyngitis (6.6% to 9.1%), sinusitis (1.1% to 4.9%), upper respiratory tract infection (1.1% to 3.4%), viral upper respiratory tract infection (0.5% to 2.3%), fungal infection (2% or more), and urinary tract infection (e.g., cystitis, 2% or more). In pediatric patients 6 to 11 years of age, nasopharyngitis, pharyngitis streptococcal, and otitis media were all reported in 3% or more of patients. Bronchitis necessitated either the discontinuation of omalizumab or the need for a concomitant medication in 0.2% of pediatric patients 6 to 11 years of age. Monitor patients at high risk of geohelminth infection while receiving omalizumab therapy. In a Brazilian study, patients were at higher risk of developing a geohelminth infection (53% vs. 42% placebo; odds ratio 1.96, 95% CI: 0.88, 4.36). This study indicated that patients who had an infection were anywhere from 0.88 to 4.36 times as likely to have received omalizumab than those who did not have an infection.
Omalizumab can cause serious hypersensitivity reactions or anaphylaxis. Anaphylaxis can occur with the first dose, but may also occur beyond 1 year after beginning regularly scheduled treatment. Approximately 60% to 70% of anaphylaxis cases occur within the first 3 doses of omalizumab, with additional cases occurring sporadically after the third dose. Documented signs and symptoms have included angioedema of the throat or tongue, bronchospasm, hypotension, syncope, hives (urticaria), dyspnea, coughing, chest tightness, and cutaneous angioedema. Most (89%) of the postmarketing cases had pulmonary involvement, and hypotension or syncope was reported in 14% of cases. Among 3,507 patients in premarketing clinical trials, 3 (0.1%) had anaphylaxis that was attributed to omalizumab. Anaphylaxis occurred with the first omalizumab dose in 2 patients and with the fourth dose in the other patient. The time to onset of anaphylaxis was 90 minutes after administration in 2 patients and 2 hours after administration in 1 patient. A retrospective case-control study of asthma patients demonstrated that a self-reported history of anaphylaxis to foods, medications, or other causes was more common among patients who experienced anaphylaxis to omalizumab (OR 8.1, 95% CI 2.7 to 24.3) compared to controls with no history of anaphylaxis. Cases of anaphylaxis based on spontaneous postmarketing reports have also been received. Based on an estimated postmarketing exposure of about 57,300 patients from June 2003 through December 2006, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2%; reports are voluntary, so the actual frequency of anaphylaxis and time to symptom onset for the entire exposed population may be different. Diagnostic anaphylaxis criteria for the postmarketing reports were skin or mucosal tissue involvement, a temporal relationship to omalizumab administration with no other identifiable cause, and airway compromise and/or reduced blood pressure with or without associated symptoms. Most cases (39%) occurred with the first dose, but 19% occurred with the second dose, 10% occurred with the third dose, and 32% after subsequent doses. One case occurred after 39 doses; after 19 months of continuous therapy, anaphylaxis occurred when treatment was restarted after a 3 month gap. The time to onset of anaphylaxis in these cases was up to 30 minutes in 35%, 31 to 60 minutes in 16%, 61 to 90 minutes in 2%, 91 to 120 minutes in 6%, 2 to 6 hours in 5%, 6 to 12 hours in 14%, 12 to 24 hours in 8%, and greater than 24 hours and up to 4 days in 5%. In 9% of cases, the time to onset was unknown. Of note, a previous history of anaphylaxis unrelated to omalizumab was reported in 24% of the cases. Among 4 patients who had hives but not anaphylaxis after omalizumab receipt, all 4 developed anaphylaxis upon omalizumab rechallenge. Also, 18 of 23 patients who had anaphylaxis developed a recurrence of similar symptoms of anaphylaxis upon omalizumab rechallenge. Instruct patients on the signs and symptoms of anaphylaxis, including the potential for a delayed reaction to the drug; reports of anaphylaxis up to 4 days after administration of omalizumab have been received. Also, instruct patients to seek immediate medical care should signs or symptoms occur. In addition, patients should carry emergency anaphylactic self-treatment and be familiar with instructions for use. If a severe hypersensitivity reaction occurs, permanently discontinue omalizumab; omalizumab is contraindicated for use by patients who have experienced a severe hypersensitivity reaction to the drug. Omalizumab should not be used for the emergency treatment of allergic reactions, including anaphylaxis. The safety and effectiveness of omalizumab for emergency treatment of allergic reactions has not been established. Advise patients that omalizumab is for maintenance use to reduce allergic reactions while avoiding food allergens.
In rare cases, patients with asthma receiving omalizumab may present with serious systemic eosinophilia sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. A causal relationship has not been determined. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Clinicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. Severe thrombocytopenia has also been noted in postmarketing reports.
CNS adverse events occurring in patients 12 years and older during omalizumab allergic asthma clinical trials included headache (15%) and dizziness (3%). Headache was also reported in 3% or more of pediatric patients 6 to 11 years of age and necessitated either the discontinuation of omalizumab or the need for a concomitant medication in 0.2% of patients in this age group. During clinical trial experience in adult and pediatric patients 12 years and older with chronic spontaneous urticaria (CSU), headache was reported in 6.1% to 12% of patients. Migraine, sinus headache, and anxiety were each reported in 2 % or more of patients. Headache (8.1%) and dizziness (3%) were reported in adult patients receiving omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP).
Other adverse events occurring in patients during clinical trials with omalizumab include unspecified pain (7%), fatigue (3%), and peripheral edema (2% or more). Oropharyngeal pain and toothache (dental pain) were noted in 2% or more of patients, while earache (otalgia) was reported in 2% of patients. Cough (1.1 to 2.2%), asthma (2% or more), and nausea (1.1 to 2.7%) were also observed.
Upper abdominal pain, gastroenteritis, and epistaxis were reported in 3% or more of pediatric patients 6 to 11 years of age with asthma during clinical trials. Upper abdominal pain was reported in 3% of adults receiving omalizumab for chronic rhinosinusitis with nasal polyps.
Musculoskeletal adverse reactions to omalizumab observed in patients during clinical trials included bone fractures (2%), leg pain (4%), arm pain (2%), unspecified extremity pain (2% or more), musculoskeletal pain (2% or more), and myalgia (2% or more).
In 2009, the FDA reported it is reviewing safety concerns that suggest omalizumab may be associated with cardiovascular and cerebrovascular adverse effects. Interim findings from a 5-year, observational study, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), suggest an increased number of cardiac and cerebrovascular events in the approximately 5,000 patients who received omalizumab as compared with the approximately 2500 patients who did not receive omalizumab; all patients were at least 12 years of age and had moderate to severe asthma. In 2014, the FDA announced that review of the 5-year safety study found a higher incidence rate (per 1,000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events in omalizumab-treated patients (13.4) compared to non-omalizumab-treated patients (8.1). Increases in rates were observed for transient ischemic attacks (TIAs) (0.7 versus 0.1); myocardial infarction (MI) (2.1 versus 0.8); unstable angina (2.2 versus 1.4); pulmonary hypertension (0.5 versus 0); and thromboembolism, specifically pulmonary embolism and/or venous thrombosis (3.2 versus 1.5); the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The FDA cannot definitively confirm or determine the exact increased level of these risks with omalizumab due to limitations in the study, including the observational study design, the inclusion of patients previously exposed to omalizumab (88%), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate limit the ability to quantify the magnitude of the risk. To further evaluate these adverse events, the FDA reviewed a combined analysis of 25 randomized double-blind clinical trials comparing omalizumab to placebo; an increased risk of these events was not evident in patients treated with omalizumab. However, certain factors limit conclusions about the absence of a risk, including the low number of these events, the young patient population, and the short duration of follow-up. As a result of the safety study review and the combined clinical trials, the FDA has added information about these potential risks to the drug label. Patients taking omalizumab should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals.
In clinical trials, new primary malignancy occurred in 0.5% (20 of 4127) omalizumab exposed patients compared to 0.2% (5 of 2,236) control subjects. The duration of omalizumab exposure varied among the clinical studies and was generally less than 1 year for most subjects. The observed malignancies were varied with breast, non-melanoma skin, prostate, melanoma, and parotid malignancies occurring more than once, and 5 other types occurring once each. In 2014, the FDA announced that review of a 5-year safety study of 5,007 omalizumab-treated and 2,829 non- omalizumab-treated patients found no difference in the incidence rates of primary malignancies (per 1,000 patient years) between those patients being treated with omalizumab (12.3) and those who were not being treated with the drug (13). However, the FDA cannot rule out a potential risk of malignancy with omalizumab due to limitations in the 5-year study, including the observational study design, the bias introduced by allowing enrollment of patients previously exposed to omalizumab (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%).
Antibody formation to omalizumab has been documented by low titers of antibodies in 1/1,723 (less than 0.1%) of adult and pediatric patients 12 years of age and older and 1/581 (less than 0.1%) of pediatric patients 6 to 11 years of age treated with omalizumab in clinical trials. The data reflect test results considered positive for antibodies to omalizumab using ELISA assay and are highly dependent on the sensitivity and specificity of the assay.
Omalizumab administration has a risk of serious hypersensitivity reactions or anaphylaxis, and omalizumab hypersensitivity may occur after any dose of omalizumab. Omalizumab is derived from Chinese hamster ovarian cells and may be inappropriate for use by patients with known hamster protein hypersensitivity. Omalizumab is contraindicated for use by patients who have experienced a severe omalizumab hypersensitivity reaction, including anaphylaxis or a history of angioedema with the drug. The initiation of omalizumab therapy requires a specialized care setting that is equipped and prepared to manage serious hypersensitivity reactions, including anaphylaxis, that can be life-threatening. The selection of patients for self-administration should be based on criteria to mitigate risk from anaphylaxis. Select patients with no prior history of anaphylaxis related or unrelated to omalizumab, who have received at least 3 doses of omalizumab, have the ability to recognize and manage signs and symptoms of a severe hypersensitivity reaction (including anaphylaxis), and can perform injections with proper technique and per the prescribed dosing regimen. Anaphylaxis has occurred after the first omalizumab dose but also has been reported after 1 year of regularly administered treatment. Approximately 60% to 70% of anaphylaxis cases occur within the first 3 doses of omalizumab, with additional cases occurring sporadically after the third dose. Documented signs and symptoms have included bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Closely observe patients for an appropriate period of time after each injection of omalizumab, taking into account the noted time to onset of anaphylaxis seen during clinical trials and postmarketing spontaneous reports. While anaphylaxis has most commonly occurred within 1 hour of injection, some cases have been reported up to 120 minutes after a dose, and some anaphylactic reactions have been delayed. Anaphylaxis was reported in 0.1% of patients during clinical asthma trials with omalizumab. In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% based on an estimated exposure of 57,300 patients from June 2003 through December 2006. A case-control study in asthma patients showed that omalizumab-treated patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis from omalizumab compared to patients with no prior history of anaphylaxis. Instruct patients on the signs and symptoms of anaphylaxis, including the potential for a delayed reaction to the drug, and to seek immediate medical care should symptoms occur. Discontinue omalizumab treatment in any patient who develops a severe hypersensitivity reaction. Omalizumab should not be used for the emergency treatment of allergic reactions, including anaphylaxis. The safety and effectiveness of omalizumab for emergency treatment of allergic reactions has not been established. Advise patients that omalizumab is for maintenance use to reduce allergic reactions while avoiding food allergens.
Omalizumab does not alleviate acute asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus. Do not abruptly discontinue systemic or inhaled corticosteroid therapy upon initiation of omalizumab therapy for asthma. Decreases in corticosteroid therapy during omalizumab treatment should be performed under the direct supervision of a prescriber and may need to be performed gradually. During omalizumab therapy, patients receiving omalizumab should be told not to decrease the dose of, or stop taking, any other medications for their condition unless otherwise instructed by their prescriber. If asthma remains uncontrolled or worsens after initiation of treatment with omalizumab, patients should seek medical advice.
Caution is advised when oral corticosteroid withdrawal or a reduction in corticosteroid dose is being considered in patients taking omalizumab. In rare cases, patients with asthma on therapy with omalizumab may present with serious systemic eosinophilia sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of systemic (oral) corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitis or vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or peripheral neuropathy presenting in their patients. A causal association between omalizumab and these underlying conditions has not been established.
In postmarketing use, some patients have experienced a constellation of signs and symptoms including arthritis and/or arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of omalizumab. These signs and symptoms have recurred after additional doses in some patients. Although circulating immune complexes or a skin biopsy consistent with a Type III reaction were not seen with these cases, these signs and symptoms are similar to those seen in patients with serum sickness. Physicians should stop omalizumab treatment if a patient develops this constellation of signs and symptoms.
Use omalizumab cautiously in patients with a history of neoplastic disease. In clinical trials of adults and adolescents 12 years of age and older with asthma or other allergic conditions, malignant neoplasms were observed in 20 of 4,127 (0.5%) omalizumab-treated patients compared with 5 of 2,236 (0.2%) control patients. The observed new primary malignancy types in omalizumab-treated patients varied, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and 5 other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to omalizumab or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known. In a subsequent observational study of 5,007 omalizumab-treated and 2,829 non-omalizumab-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen, patients were followed for up to 5 years. In this study, the incidence rates of primary malignancies (per 1,000 patient-years) were similar among omalizumab-treated (12.3) and non-omalizumab-treated patients (13). However, study limitations preclude definitively ruling out a malignancy risk with omalizumab. Study limitations include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to omalizumab (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were trial exclusion criteria, and the high study discontinuation rate (44%).
Monitor patients at high risk of geo-helminth infection while on omalizumab therapy. Insufficient data are available to determine the length of monitoring required for geo-helminth infections in these patients after stopping omalizumab treatment. In a one-year clinical trial conducted in Brazil in adult and adolescent patients at high risk for geo-helminth infection, as diagnosed by standard stool examination, compared to 42% (29/69) of placebo controls. The point estimate of the odds ratio for infection was 1.96 (95% CI, 0.88, 4.36); the study indicated that a patient with geo-helminth infection was anywhere from 0.88 to 4.36 times as likely to have received omalizumab than a patient who did not have an infection. Response to appropriate treatment of geo-helminth infection, as measured by stool egg counts, was not different between treatment groups.
The data with omalizumab use during human pregnancy are insufficient to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women and its ability to cause fetal harm or affect reproductive capacity is unknown. Monoclonal antibodies, such as omalizumab, are known to cross the placenta; therefore, omalizumab may be transmitted from the mother to the fetus. A registry study of omalizumab exposure in 250 pregnant women showed no increase in the rate of major birth defects or miscarriage. Although there was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, women taking omalizumab during pregnancy had more severe asthma, which makes it difficult to determine if the low birth weight is due to the drug or disease severity. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Thus, asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.
There are limited data regarding the use of omalizumab during breast-feeding. There is no information regarding the presence of omalizumab in human milk or the effects on milk production. A majority of the infants (80.9%, 186/230) in the pregnancy registry study of omalizumab were breastfed. Events categorized as "infections and infestations" were not significantly increased in infants exposed to omalizumab compared with infants who were not breastfed or infants who were breastfed without exposure to omalizumab. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Safety and efficacy of omalizumab for asthma and chronic spontaneous urticaria have not been established in neonates, infants, and children less than 6 years of age. Safety and efficacy of omalizumab for chronic rhinosinusitis with nasal polyps has not been established in patients less than 18 years of age. Safety and efficacy of omalizumab for IgE-mediated food allergies has not been established in patients less than 1 year of age.
Omalizumab 75 mg/0.5 mL and 150 mg/mL prefilled syringes should be administered cautiously to patients with a possible history of latex hypersensitivity because the needle cap contains a derivative of natural rubber latex. The omalizumab autoinjector is not made with natural rubber latex.
For asthma maintenance add-on therapy for moderate to severe persistent asthma:
-for baseline serum IgE 30 to 100 International Units/mL:
Subcutaneous dosage:
Adults weighing 91 to 150 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 6 to 17 years weighing 91 to 150 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 30 to 90 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 30 to 90 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 41 to 90 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 40 kg: 75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 101 to 200 International Units/mL:
Subcutaneous dosage:
Adults weighing 91 to 150 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 91 to 150 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 30 to 90 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 30 to 90 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 126 to 150 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 91 to 125 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 41 to 90 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 40 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 201 to 300 International Units/mL:
Subcutaneous dosage:
Adults weighing 91 to 150 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 91 to 150 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 61 to 90 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 61 to 90 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 30 to 60 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 30 to 60 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 126 to 150 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 91 to 125 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 61 to 90 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 41 to 60 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 31 to 40 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 30 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 301 to 400 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 90 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children and Adolescents 6 to 17 years weighing more than 90 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Adults weighing 71 to 90 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 71 to 90 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 30 to 70 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 30 to 70 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 71 to 90 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 41 to 70 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 31 to 40 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 30 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 401 to 500 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 90 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children and Adolescents 6 to 17 years weighing more than 90 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Adults weighing 71 to 90 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 71 to 90 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 30 to 70 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 30 to 70 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 71 to 90 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 51 to 70 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 31 to 50 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 26 to 30 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 25 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 501 to 600 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 70 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children and Adolescents 6 to 17 years weighing more than 70 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Adults weighing 61 to 70 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 61 to 70 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 30 to 60 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 30 to 60 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 61 to 70 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 41 to 60 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 31 to 40 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 30 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 601 to 700 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 60 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children and Adolescents 6 to 17 years weighing more than 60 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Adults weighing 30 to 60 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children and Adolescents 12 to 17 years weighing 30 to 60 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 51 to 60 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 41 to 50 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 26 to 40 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 25 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 701 to 900 International Units/mL:
Subcutaneous dosage:
Children 6 to 11 years old weighing more than 50 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children 6 to 11 years weighing 41 to 50 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 31 to 40 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 30 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 901 to 1,100 International Units/mL:
Subcutaneous dosage:
Children 6 to 11 years weighing more than 40 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children 6 to 11 years weighing 31 to 40 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 26 to 30 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 25 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 1,101 to 1,200 International Units/mL:
Subcutaneous dosage:
Children 6 to 11 years weighing more than 30 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children 6 to 11 years weighing 20 to 30 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 1,201 to 1,300 International Units/mL:
Subcutaneous dosage:
Children 6 to 11 years weighing more than 30 kg: No dosage recommendations are available; there are insufficient data in this weight group.
Children 6 to 11 years weighing 26 to 30 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Children 6 to 11 years weighing 20 to 25 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
For the treatment of chronic spontaneous urticaria in patients who remain symptomatic despite H1 antihistamine treatment:
Subcutaneous dosage:
Adults: 150 mg or 300 mg subcutaneously every 4 weeks. Dosing is independent of serum IgE and body weight. Periodically reassess the need for continued treatment; optimal treatment duration has not been determined. In clinical trials, a larger proportion of patients treated with 300 mg every 4 weeks reported no itching or hives after 12 weeks of treatment compared to those treated with 150 mg every 4 weeks (36% vs. 15%).
Children and Adolescents 12 to 17 years: 150 mg or 300 mg subcutaneously every 4 weeks. Dosing is independent of serum IgE and body weight. Periodically reassess the need for continued treatment; optimal treatment duration has not been determined. In clinical trials, a larger proportion of patients treated with 300 mg every 4 weeks reported no itching or hives after 12 weeks of treatment compared to those treated with 150 mg every 4 weeks (36% vs. 15%).
For the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults with inadequate response to nasal corticosteroids:
NOTE: For adults with both asthma and CRSwNP, determine dosing based on the primary diagnosis for which omalizumab is being prescribed.
-for baseline serum IgE 30 to 100 International Units/mL:
Subcutaneous dosage:
Adults weighing 91 to 150 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 90 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 101 to 200 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 91 to 125 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 90 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 201 to 300 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 91 to 125 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 61 to 90 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 60 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 301 to 400 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 91 to 125 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 71 to 90 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 70 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 401 to 500 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 91 to 125 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 71 to 90 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 51 to 70 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 50 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 501 to 600 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 125 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 91 to 125 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 71 to 90 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 61 to 70 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 60 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 601 to 700 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 90 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 81 to 90 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 61 to 80 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 51 to 60 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 50 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 701 to 800 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 90 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 81 to 90 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 71 to 80 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 51 to 70 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 50 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 801 to 900 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 80 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 71 to 80 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 61 to 70 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 51 to 60 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 50 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 901 to 1,000 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 70 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 61 to 70 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 51 to 60 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 50 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 1,001 to 1,100 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 60 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 51 to 60 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 50 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 1,101 to 1,200 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 60 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 51 to 60 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 41 to 50 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 1,201 to 1,300 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 50 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 41 to 50 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
-for baseline serum IgE 1,301 to 1,500 International Units/mL:
Subcutaneous dosage:
Adults weighing more than 50 kg: A dosage cannot be recommended due to insufficient data in this weight group.
Adults weighing 41 to 50 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
Adults weighing 31 to 40 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight.
For the treatment of allergic bronchopulmonary aspergillosis*:
Subcutaneous dosage:
Adults: 75 to 600 mg subcutaneously every 2 to 4 weeks. Dose range: 150 to 1,200 mg/month. Dosing varies based on age, weight, and baseline serum IgE.
Children and Adolescents: 75 to 600 mg subcutaneously every 2 to 4 weeks. Dose range: 150 to 1,200 mg/month. Dosing varies based on age, weight, and baseline serum IgE.
For the maintenance reduction of IgE-mediated food allergy:
-for baseline serum IgE 30 to 100 International Units/mL:
Subcutaneous dosage:
Adults weighing 91 to 150 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 91 to 150 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 90 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 90 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 40 kg: 75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.-for baseline serum IgE 101 to 200 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 126 to 150 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 91 to 125 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents 91 to 125 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 90 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 90 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 40 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 20 kg: 75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 201 to 300 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 126 to 150 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 91 to 125 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 91 to 125 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 61 to 90 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 61 to 90 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 60 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 60 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 30 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 15 kg: 75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 301 to 400 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 126 to 150 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 91 to 125 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 91 to 125 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 71 to 90 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 71 to 90 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 70 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 70 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 30 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 20 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 401 to 500 International Units/mL:
Subcutaneous dosage:
Adults weighing 126 to 150 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 126 to 150 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 91 to 125 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 91 to 125 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 71 to 90 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 71 to 90 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 51 to 70 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 51 to 70 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 50 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 50 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 26 to 30 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 25 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 15 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 501 to 600 International Units/mL:
Subcutaneous dosage:
Adults weighing 91 to 125 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 91 to 125 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 71 to 90 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 71 to 90 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 61 to 70 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 61 to 70 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 60 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 60 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 30 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 20 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 15 kg: 150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 601 to 700 International Units/mL:
Subcutaneous dosage:
Adults weighing 81 to 90 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents 81 to 90 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 61 to 80 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 61 to 80 kg : 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 51 to 60 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 51 to 60 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 50 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 600 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 450 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 26 to 30 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 25 kg: 300 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 20 kg: 225 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 15 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 701 to 800 International Units/mL:
Subcutaneous dosage:
Adults weighing 81 to 90 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 81 to 90 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 71 to 80 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 71 to 80 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 51 to 70 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 51 to 70 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 50 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 30 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 20 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 801 to 900 International Units/mL:
Subcutaneous dosage:
Adults weighing 71 to 80 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 71 to 80 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 61 to 70 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 61 to 70 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 51 to 60 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 51 to 60 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 50 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 30 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 20 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 901 to 1,000 International Units/mL:
Subcutaneous dosage:
Adults weighing 61 to 70 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 61 to 70 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 51 to 60 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 51 to 60 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 50 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 26 to 30 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 25 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 15 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 1,001 to 1,100 International Units/mL:
Subcutaneous dosage:
Adults weighing 51 to 60 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 51 to 60 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 50 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 26 to 30 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents 16 to 25 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing between 10 and 15 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 1,101 to 1,200 International Units/mL:
Subcutaneous dosage:
Adults weighing 51 to 60 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 51 to 60 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 41 to 50 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 30 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 20 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 15 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 1,201 to 1,300 International Units/mL:
Subcutaneous dosage:
Adults weighing 41 to 50 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 26 to 30 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 25 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 13 to 20 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 12 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 1,301 to 1,500 International Units/mL:
Subcutaneous dosage:
Adults weighing 41 to 50 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 41 to 50 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Adults weighing 31 to 40 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 525 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 26 to 30 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 25 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 13 to 15 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 10 to 12 kg: 150 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
-for baseline serum IgE 1,501 to 1,850 International Units/mL:
Subcutaneous dosage:
Adults weighing 31 to 40 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 31 to 40 kg: 600 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 26 to 30 kg: 450 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 21 to 25 kg: 375 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 16 to 20 kg: 300 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Children and Adolescents weighing 13 to 15 kg: 225 mg subcutaneously every 2 weeks. Adjust doses for significant changes in body weight. Use in conjunction with food allergen avoidance.
Therapeutic Drug Monitoring:
Asthma, IgE-mediated Food Allergy, or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Initial dose (mg) and dosing frequency is determined by serum total IgE level (IU/mL) measured before the start of treatment, body weight (kg), and for asthma, patient age. Adjust doses for significant changes in body weight during treatment.
Total IgE concentrations are elevated during treatment and remain elevated for up to 1 year after omalizumab is discontinued; therefore, re-testing of serum total IgE levels during omalizumab treatment cannot be used as a guide for dose determination.
If therapy is interrupted:
-If treatment is interrupted for less than 1 year, the dose should be based on serum total IgE levels obtained at the initial dosage determination.
-For treatment interruptions lasting 1 year or more, re-test total serum IgE levels for determination of dose (mg) and dosing frequency in conjunction with the patient's weight (kg) and for asthma, patient age.
Periodically reassess the need for continued therapy based upon the patient's disease severity and level of symptom control.
Chronic Idiopathic Urticaria (CIU)
Dosing of omalizumab in CIU patients is not dependent on serum IgE (free or total) levels or body weight. Periodically reassess the need for continued therapy based on clinical status.
Maximum Dosage Limits:
-Adults
For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic spontaneous urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of chronic rhinosinusitis with nasal polyps and IgE-mediated food allergies: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.
-Geriatric
For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic spontaneous urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of chronic rhinosinusitis with nasal polyps and IgE-mediated food allergies: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.
-Adolescents
For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic spontaneous urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of IgE-mediated food allergies: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.
For the treatment of chronic rhinosinusitis with nasal polyps: Safety and efficacy have not been established.
-Children
12 years:
For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic spontaneous urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of IgE-mediated food allergies: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.
For the treatment of chronic rhinosinusitis with nasal polyps: Safety and efficacy have not been established.
6 to 11 years:
For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight.
-6 to 11 years and more than 25 kg: Not to exceed 375 mg subcutaneously every 2 weeks.
-6 to 11 years and 20 to 25 kg: Not to exceed 300 mg subcutaneously every 2 weeks.
For the treatment of IgE-mediated food allergies: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.
For the treatment of chronic spontaneous urticaria or chronic rhinosinusitis with nasal polyps: Safety and efficacy have not been established.
1 to 5 years:
For the treatment of IgE-mediated food allergies: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.
For the treatment of asthma, chronic spontaneous urticaria, or chronic rhinosinusitis with nasal polyps: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-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
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.
Dengue Tetravalent Vaccine, Live: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the dengue virus vaccine. When feasible, administer indicated vaccines at least 2 weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
SARS-CoV-2 (COVID-19) vaccines: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus 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 SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) Adenovirus Vector Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus 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 SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) mRNA Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus 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 SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) Recombinant Spike Protein Nanoparticle Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus 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 SARS-CoV-2 virus after receiving the vaccine.
Omalizumab binds to human IgE's high affinity Fc receptor (Fc epsilonRI), preventing the binding of IgE to a variety of cells associated with the allergic response and lowering free serum IgE concentrations. Avoiding the bridging between IgE and cells associated with allergic response prevents degranulation of such cells and, thereby, the release of inflammatory mediators. The early phase of allergic response is prevented as omalizumab prohibits IgE's binding to mast cells, preventing mast cell degranulation. The late phase of allergic response is prevented when the IgE-anti-IgE complex is unable to bind to (Fc epsilonRI) receptors on monocytes, eosinophils, dendritic cells, epithelial cells, and platelets, thus interfering with mediator/cytokine release. Omalizumab indirectly causes a notable down-regulation of (Fc epsilonRI) on basophils, and also prevents IgE from interacting with low affinity Fc receptors ((Fc epsilonRII)) on antigen-presenting cells. IgE-anti-IgE complexes are non-immunogenic with a half-life of about 40 days and persist in circulation for a prolonged time; these hexamers have unoccupied antigen binding sites and are able to remove from the circulation those allergens against which the patient's IgE is directed. Omalizumab has been found in clinical trials to reduce free serum IgE concentrations by more than 90%, considerably suppress eosinophils in induced sputum, and blunt both early and late phase allergic responses.
Omalizumab is administered by subcutaneous injection. Once omalizumab is in the serum, it forms complexes of limited size with IgE; there is no evidence of omalizumab distribution into any other tissues or organs. The apparent volume of distribution of omalizumab in patients with asthma following subcutaneous administration was 78 +/- 32 mL/kg; distribution of omalizumab was similar in patients with chronic spontaneous urticaria (CSU). Clearance of omalizumab involved IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE. Liver elimination of IgG included degradation in the liver reticuloendothelial system (RES) and endothelial cells. Intact IgG was also excreted in bile. In studies with mice and monkeys, omalizumab:IgE complexes were eliminated by interactions with Fc-gamma receptors within the RES at rates that were generally faster than IgG clearance. In asthma patients, the omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 +/- 1.1 mL/kg/day. Doubling body weight approximately doubled the apparent clearance in these patients. Studies suggested the pharmacokinetics of omalizumab in chronic rhinosinusitis with nasal polyps (CRSwNP) were consistent with that in asthma. In CSU patients, at steady state, based on population pharmacokinetics, omalizumab serum elimination half-life averaged 24 days and apparent clearance averaged 240 mL/day (corresponding to 3 mL/kg/day for an 80 kg patient).
In patients with asthma, serum free IgE concentrations are reduced in a dose dependent manner within 1 hour of the first dose of omalizumab and are maintained between doses. The mean serum free IgE decrease is greater than 96% when using recommended dosages. Serum total IgE levels (i.e., bound and unbound) increase after the first dose due to the formation of omalizumab:IgE complexes, which have a slower elimination rate compared to free IgE. At 16 weeks after the first dose, average serum total IgE levels are 5-fold higher compared with pre-treatment when using standard assays. After discontinuation of omalizumab, the omalizumab-induced increase in total IgE and decrease in free IgE are reversible, with no observed rebound in IgE concentrations after drug washout. Total IgE concentrations do not appear to return to pre-treatment levels for up to 1 year after discontinuation of omalizumab.
In patients with CSU, omalizumab treatment led to a dose-dependent reduction of serum free IgE and an increase of serum total IgE levels, similar to the observations in asthma patients. Maximum suppression of free IgE was observed 3 days following the first subcutaneous dose. After repeat dosing once every 4 weeks, predose serum free IgE levels remained stable between 12 and 24 weeks of treatment. Total IgE levels in serum increased after the first dose due to the formation of omalizumab-IgE complexes which have a slower elimination rate compared with free IgE. After repeat dosing once every 4 weeks at 75 mg up to 300 mg, average predose serum total IgE levels at Week 12 were 2- to 3-fold higher compared with pre-treatment levels, and remained stable between 12 and 24 weeks of treatment. After discontinuation of omalizumab dosing, free IgE levels increased and total IgE levels decreased towards pre-treatment levels over a 16-week follow-up period.
In patients with CRSwNP, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to the observations in asthma patients. The mean total IgE concentrations at baseline were 168 IU/mL and 218 IU/mL in Nasal Polyp Trial 1 and 2, respectively. After repeated dosing every 2 or 4 weeks, the mean predose free IgE concentrations at Week 16 were 10.0 IU/mL in Trial 1 and 11.7 IU/mL in Trial 2 and remained stable at 24 weeks of treatment. Total IgE levels in serum increased due to the formation of omalizumab-IgE complexes, which have a slower elimination rate compared with free IgE. After repeated dosing every 2 or 4 weeks, mean and median predose serum total IgE levels at Week 16 were 3-to 4-fold higher compared with pre-treatment levels, and remained stable between 16 and 24 weeks of treatment.
In patients with IgE-mediated food allergy, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to that observed with asthma patients. The mean total IgE concentration at baseline was 810 IU/mL. After repeated dosing every 2 or 4 weeks, the mean pre-dose free IgE concentration at Week 16 was 10 IU/mL. Mean total IgE levels in serum increased about 2.4-fold due to the formation of omalizumab-IgE complexes, which have a longer half-life compared with free IgE.
Affected cytochrome P450 isoenzymes and drug transporters: None
-Route-Specific Pharmacokinetics
Subcutaneous Route
After subcutaneous administration, omalizumab is absorbed slowly into the serum where it forms complexes with IgE. Maximum serum concentrations are achieved within 7 to 8 days. The average absolute bioavailability is 62%.
-Special Populations
Hepatic Impairment
No specific pharmacokinetic data are available.
Renal Impairment
No specific pharmacokinetic data are available.
Pediatrics
Pediatric age does not influence the pharmacokinetic parameters of omalizumab in the treatment of asthma, IgE-mediated food allergy, or chronic spontaneous urticaria (CSU).
Geriatric
Geriatric age does not appear to influence the pharmacokinetic parameters of omalizumab in the treatment of asthma, chronic spontaneous urticaria (CSU), IgE-mediated food allergy, or chronic rhinosinusitis with nasal polyps (CRSwNP).
Gender Differences
Gender does not influence the pharmacokinetic parameters of omalizumab in the treatment of asthma, chronic spontaneous urticaria (CSU), IgE-mediated food allergy, or chronic rhinosinusitis with nasal polyps (CRSwNP).
Ethnic Differences
Ethnicity does not influence the pharmacokinetic parameters of omalizumab in the treatment of asthma, chronic spontaneous urticaria (CSU), IgE-mediated food allergy, or chronic rhinosinusitis with nasal polyps (CRSwNP).
Obesity
Body weight does not influence the pharmacokinetic parameters of omalizumab in the treatment of chronic spontaneous urticaria. In the treatment of asthma, doubling body weight approximately doubled the apparent clearance of omalizumab. Doses are adjusted to body weight in the treatment of asthma, IgE-mediated food allergies, and chronic rhinosinusitis with nasal polyps (CRSwNP).