AdultPediatricDosage Forms & Strengths injection, single-dose prefilled syringe 75mg/0.5mL 150mg/mL injection, lyophilized powder for reconstitution 150mg/vial 125mg/mL after reconstitution Asthma Indicated for moderate-to-severe persistent asthma in adults with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids 150-375 mg SC q2-4Weeks Determine precise dose and frequency by total IgE level and body weight measured before starting therapy and then periodically (see manufacturer’s prescribing information) Periodically reassess the need for continued therapy based upon disease severity and level of symptom control Chronic Idiopathic Urticaria Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment 150-300 mg SC q4weeks Dosing in CIU patients is not dependent on serum IgE level or body weight Treatment duration for CIU has not been evaluated; periodically reassess the need for continued therapy Nasal Polyps Indicated for add-on maintenance treatment of nasal polyps in adults aged ≥18 years with inadequate response to nasal corticosteroids 75-600 mg SC q2-4weeks Determine precise dose and frequency by total IgE level and body weight measured before starting therapy and then periodically (see manufacturer’s prescribing information) Periodically reassess the need for continued therapy based upon disease severity and level of symptom control Dosing Considerations Asthma and nasal polyps Determine dose and administration frequency by serum total IgE level (IU/mL) measured before initiating, and by body weight Adjust dose for significant changes in body weight during treatment Total IgE levels after initiating Elevated during treatment and for up to 1 year after discontinuing treatment; therefore,re-testing IgE levels cannot be used as a guide for dose determination Interruptions lasting <1 year: Dose based on serum IgE levels obtained at initial dose determination Interruptions lasting >1 year: Re-test total serum IgE levels for dose determination Limitations of use Asthma: Not indicated for the relief of acute bronchospasm or status asthmaticus, or for treating other allergic conditions CIU: Not indicated for other forms of urticaria Dosage Forms & Strengths injection, single-dose prefilled syringe 75mg/0.5mL 150mg/mL injection, lyophilized powder for reconstitution 150mg/vial 125mg/mL after reconstitution Asthma Indicated for moderate-to-severe persistent asthma in children aged ≥6 years with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids <6 years: Safety and efficacy not established 6 to <12 years: 75-375 mg SC q2-4Weeks ≥12 years: 150-375 mg SC q2-4Weeks Determine precise dose and frequency by total IgE level and body weight measured before starting therapy and then periodically (see manufacturer’s prescribing information) Periodically reassess the need for continued therapy based upon disease severity and level of symptom control Chronic Idiopathic Urticaria Indicated for chronic idiopathic urticaria (CIU) in children aged ≥12 years who remain symptomatic despite H1 antihistamine treatment <12 years: Safety and efficacy not established ≥12 years: 150-300 mg SC q4weeks Dosing in CIU patients is not dependent on serum IgE level or body weight Treatment duration for CIU has not been evaluated; periodically reassess the need for continued therapy Dosing Considerations Asthma Determine dose and administration frequency by serum total IgE level (IU/mL) measured before initiating, and by body weigh Adjust doses for significant changes in body weight during treatment Total IgE levels after initiating Elevated during treatment and for up to 1 year after discontinuing treatment; therefore, re-testing IgE levels cannot be used as a guide for dose determination Interruptions lasting <1 year: Dose based on serum IgE levels obtained at initial dose determination Interruptions lasting >1 year: Re-test total serum IgE levels for dose determination Limitations of use Asthma: Not indicated for the relief of acute bronchospasm or status asthmaticus, or for treating other allergic conditions CIU: Not indicated for other forms of urticaria >10% Asthma (aged ≥12 yr) Injection site reactions (45%) CIU Headache (12%) 1-10% Asthma (aged ≥12 yr) Arthralgia (8%) Pain (7%) Leg pain (4%) Dizziness (3%) Fatigue (3%) Earache (2%) Pruritus (2%) Dermatitis (2%) Arm pain (2%) Fracture (2%) CIU Nasopharyngitis (9.1%) Arthralgia (2.9%) Viral upper respiratory tract infection (2.3%) Nausea (1.1%) Cough (1.1%) Sinusitis (1.1%) Upper respiratory tract infection (1.1%) Nasal polyps Headache (8.1%) Injection site reactions (5.2%) Upper abdominal pain (3%) Arthralgia (3%) Dizziness (3%) Postmarketing Reports Eosinophilic conditions Fever, arthralgia, rash: Constellation of signs and symptoms, including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness Hematologic: Severe thrombocytopenia Skin: Hair loss Black Box Warnings Anaphylaxis Anaphylaxis (eg, bronchospasm, hypotension, syncope, urticaria, angioedema of throat or tongue) reported Anaphylaxis has occurred as early as after first dose, but also has occurred beyond 1 year after beginning regularly administered treatment Initiate therapy in a healthcare setting and closely observe patients for an appropriate period after administration Be prepared to manage anaphylaxis that can be life-threatening Inform patients of the signs and symptoms of anaphylaxis and instruct to seek immediate medical care should symptoms occur Base selection for self-administration on criteria to mitigate risk from anaphylaxis Contraindications Severe hypersensitivity reaction to omalizumab or any of its excipients Cautions Risk of anaphylaxis may occur up to 24 hr after any dose, even if no reaction to the first dose; advise patients to carry emergency self-treatment; discontinue if severe hypersensitivity reaction occurs Once therapy has been established, administration by prefilled syringe outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients; patient selection, determined by healthcare provider in consultation with patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (eg, prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with prefilled syringe with proper technique according to prescribed dosing regimen and instructions for use Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating omalizumab; decrease corticosteroids gradually over weeks/months; use with corticosteroids has not been evaluated in patients with CIU Arthritis/arthralgia, rash, fever, and lymphadenopathy reported Malignant neoplasms were observed; malignancy rate was 0.5% compared to 0.2% of controls in clinical trials; a 5-year study found difference in the rates of cancer between omalizumab-treated patients and those who were not treated, but due to limitations of the study, increased cancer risk cannot be ruled out Monitor patients at high risk for geohelminth infection while taking omalizumab Monitor for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids Not shown to alleviate asthma exacerbations acutely; not for use in acute bronchospasm or status asthmaticus; patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with therapy Elevated serum total IgE levels may persist for up to 1 yr following discontinuation; do not use serum total IgE levels obtained <1 year following discontinuation to reassess dosing regimen for asthma or nasal polyps Pregnancy Exposure during pregnancy showed no increase in rate of major birth defects or miscarriage; Increased rate of low birth weight among registry infants compared to infants in the other cohorts reported, despite average gestational age at birth; however, women taking the drug during pregnancy also had more severe asthma, which makes it difficult to determine whether ow birth weight is due to drug or disease severity Monoclonal antibodies, such as omalizumab, are transported across placenta in a linear fashion as pregnancy progresses; potential effects on fetus are likely to be greater during second and third trimesters of pregnancy In women with poorly or moderately controlled asthma, evidence demonstrates that there is increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control Human IgG antibodies are known to cross placental barrier; therefore, drug may be transmitted from mother to developing fetus Lactation Majority of infants (80.9%, 186/230) in pregnancy exposure registry were breastfed; events categorized as “infections and infestations” were not significantly increased in infants who were exposed through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposurePregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Recombinant humanized monoclonal antibody; selectively binds to IgE and inhibits binding to IgE receptors on surface of mast cells and basophils Absorption Bioavailability: 62% Peak Plasma Time: 7-8 days Distribution Vd: 78 +/- 32 mL/kg Metabolism Hepatic Elimination Half-Life: 26 days Total Body Clearance: 2.4 +/- 1.1 mL/kg/day Excretion: Bile SC Preparation Lyophilized powder (vials) Reconstitute vial(s) with 1.4 mL sterile water for injection (SWFI) into a 3-mL syringe equipped with a 1-inch, 18-gauge needle; resulting solution is 150 mg/1.2 mL Place vial upright on a flat surface and using standard aseptic technique, insert needle and inject the SWFI directly onto the product Keeping vial upright, gently swirl for ~1 minute to evenly wet powder; do NOT shake Gently swirl the vial for 5-10 seconds at ~5 minutes intervals until there are no visible gel-like particles in the solution; lyophilized product takes 15-20 minutes to completely dissolve; discard if contents of vial do not dissolve completely by 40 minutes Reconstituted solution will appear clear or slightly opalescent, somewhat viscous, and may have a few small bubbles or foam around the edge of the vial To obtain the full 1.2-mL dose withdraw with a new needle and 3-mL syringe all of product from the vial before expelling any air or excess solution from syringe Prefilled syringes Each carton contains 1 syringe Check expiration date on carton; discard if expired Remove carton from refrigerator and set aside for at least 15-30 minutes to calibrate to room temperature (leave syringe in the carton to protect it from light) Do not allow syringe to become hot or speed up the warming process in any way, and do not put the syringe in a microwave or in warm water Visually inspect syringe; solution should be clear to slightly opalescent and colorless to pale brownish-yellow; discard if the liquid is cloudy, discolored, or contains foreign particles SC Administration Administer by SC injection 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 Rotate injection site for each new injection at least 1 inch from the area used for the last injection Reconstituted vials Injection may take 5-10 seconds to administer owing to solution viscosity Do not administer >150 mg (contents of 1 vial) per injection site Divide doses >150 mg among 2 or more injection sites Periodically reassess need for continued therapy based on disease severity and level of symptom control Prefilled syringes Children aged 6-11 years (asthma and CIU): Administer by a caregiver Adults and adolescents aged >12 years: May be self-administered under supervision Storage Lyophilized powder Ship at controlled ambient temperature (≤30ºC [≤86ºF]) Refrigerate at 2-8ºC (36-46ºF) Do not use beyond the expiration date stamped on carton Prefilled syringes Ship at controlled ambient temperature (≤30ºC [≤86ºF]) Refrigerate at 2-8ºC (36-46ºF) Do not use beyond the expiration date stamped on carton Reconstituted vials Refrigerate at 2-8ºC (36-46ºF) for up to 8 hr following reconstitution or within 4 hr of reconstitution when stored at room temperature Protect from light BRAND FORM. UNIT PRICE PILL IMAGE Xolair subcutaneous- 150 mg vialCopyright © 2010 First DataBank, Inc.Print Patient Educationomalizumab subcutaneous OMALIZUMAB - INJECTION (OH-ma-LIZ-ue-mab) COMMON BRAND NAME(S): Xolair WARNING: This medication can rarely cause a very serious (sometimes fatal) allergic reaction. This reaction has occurred after the first dose or after later doses, even more than one year after starting treatment. The risk is greater if you have a history of severe allergies to