Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 08 January 2018

Indication(s)

1 INDICATIONS AND USAGE Xolair is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (1.1) Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment (1.2) Limitations of use: Not indicated for other allergic conditions or other forms of urticaria. (1.1, 1.2,) Not indicated for acute bronchospasm or status asthmaticus. (1.1, 5.3) 1.1 Asthma Xolair is indicated for patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Limitations of Use: Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus. Xolair is not indicated for treatment of other allergic conditions. 1.2 Chronic Idiopathic Urticaria (CIU) Xolair is indicated for the treatment of adults and adolescents 12 years of age and older with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. Limitation of Use: Xolair is not indicated for treatment of other forms of urticaria.

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contraindications
4 CONTRAINDICATIONS The use of Xolair is contraindicated in the following: Severe hypersensitivity reaction to Xolair or any ingredient of Xolair [see Warnings and Precautions (5.1) ]. Severe hypersensitivity reaction to Xolair or any ingredient of Xolair. (4, 5.1)
Adverse reactions
6 ADVERSE REACTIONS Use of Xolair has been associated with: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Asthma: The most common adverse reactions in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. (6.1) Chronic Idiopathic Urticaria: The most common adverse reactions (≥2% Xolair-treated patients and more frequent than in placebo) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions from Clinical Studies in Adult and Adolescent Patients 12 Years of Age and Older with Asthma The data described below reflect Xolair exposure for 2076 adult and adolescent patients ages 12 and older, including 1687 patients exposed for six months and 555 exposed for one year or more, in either placebo-controlled or other controlled asthma studies. The mean age of patients receiving Xolair was 42 years, with 134 patients 65 years of age or older; 60% were women, and 85% Caucasian. Patients received Xolair 150 to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo. The adverse events most frequently resulting in clinical intervention (e.g., discontinuation of Xolair, or the need for concomitant medication to treat an adverse event) were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in Xolair-treated patients and control patients. Table 5 shows adverse reactions from four placebo-controlled asthma trials that occurred ≥ 1% and more frequently in adult and adolescent patients 12 years of age and older receiving Xolair than in those receiving placebo. Adverse events were classified using preferred terms from the International Medical Nomenclature (IMN) dictionary. Injection site reactions were recorded separately from the reporting of other adverse events. Table 5. Adverse Reactions ≥ 1% More Frequent in Xolair-Treated Adult or Adolescent Patients 12 years of Age and Older in Four Placebo-controlled Asthma Trials Adverse reaction Xolair n = 738 Placebo n = 717 Body as a whole Pain 7% 5% Fatigue 3% 2% Musculoskeletal system Arthralgia 8% 6% Fracture 2% 1% Leg pain 4% 2% Arm pain 2% 1% Nervous system Dizziness 3% 2% Skin and appendages Pruritus 2% 1% Dermatitis 2% 1% Special senses Earache 2% 1% There were no differences in the incidence of adverse reactions based on age (among patients under 65), gender or race. Anaphylaxis Case Control Study A retrospective case-control study investigated risk factors for anaphylaxis to Xolair among patients treated with Xolair for asthma. Cases with an adjudicated history of anaphylaxis to Xolair were compared to controls with no such history. The study found that a self-reported history of anaphylaxis to foods, medications or other causes was more common among patients with Xolair anaphylaxis (57% of 30 cases) compared to controls (23% of 88 controls) [OR 8.1, 95% CI 2.7 to 24.3]. Because this is a case control study, the study cannot provide the incidence of anaphylaxis among Xolair users. From other sources, anaphylaxis to Xolair was observed in 0.1% of patients in clinical trials and at least 0.2% of patients based upon postmarketing reports [see Warnings and Precautions (5.1) , Adverse Reactions (6.3) ]. Injection Site Reactions In adults and adolescents, injection site reactions of any severity occurred at a rate of 45% in Xolair-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred more frequently in Xolair-treated patients compared with patients in the placebo group (12% versus 9%). The majority of injection site reactions occurred within 1 hour-post injection, lasted less than 8 days, and generally decreased in frequency at subsequent dosing visits. Adverse Reactions from Clinical Studies in Pediatric Patients 6 to <12 Years of Age with Asthma The data described below reflect Xolair exposure for 926 patients 6 to < 12 years of age, including 583 patients exposed for six months and 292 exposed for one year or more, in either placebo-controlled or other controlled asthma studies. The mean age of pediatric patients receiving Xolair was 8.8 years; 69% were male, and 64% were Caucasian. Pediatric patients received Xolair 75 mg to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo. No cases of malignancy were reported in patients treated with Xolair in these trials. The most common adverse reactions occurring at ≥3% in the pediatric patients receiving Xolair and more frequently than in patients treated with placebo were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis. The adverse events most frequently resulting in clinical intervention (e.g., discontinuation of Xolair, or the need for concomitant medication to treat an adverse event) were bronchitis (0.2%), headache (0.2%) and urticaria (0.2%). These events were observed at similar rates in Xolair-treated patients and control patients. Adverse Reactions from Clinical Studies in Patients with Chronic Idiopathic Urticaria (CIU) The safety of Xolair for the treatment of CIU was assessed in three placebo-controlled, multiple-dose clinical trials of 12 weeks' (CIU Trial 2) and 24 weeks' duration (CIU Trials 1 and 3). In CIU Trials 1 and 2, patients received Xolair 75, 150, or 300 mg or placebo every 4 weeks in addition to their baseline level of H1 antihistamine therapy throughout the treatment period. In CIU Trial 3 patients were randomized to Xolair 300 mg or placebo every 4 weeks in addition to their baseline level of H1 antihistamine therapy. The data described below reflect Xolair exposure for 733 patients enrolled and receiving at least one dose of Xolair in the three clinical trials, including 684 patients exposed for 12 weeks and 427 exposed for 24 weeks. The mean age of patients receiving Xolair 300 mg was 43 years, 75% were women, and 89% were white. The demographic profiles for patients receiving Xolair 150 mg and 75 mg were similar. Table 6 shows adverse reactions that occurred in ≥ 2% of patients receiving Xolair (150 or 300 mg) and more frequently than those receiving placebo. Adverse reactions are pooled from Trial 2 and the first 12 weeks of Trials 1 and 3. Table 6. Adverse Reactions Occurring in ≥2% in Xolair-Treated Patients and More Frequently than in Patients Treated with Placebo (Day 1 to Week 12) in CIU Trials CIU Trials 1, 2 and 3 Pooled Adverse Reactionsby MedDRA (15.1) System Organ Class and Preferred Term 150mg (n=175) 300mg (n=412) Placebo (n=242) Gastrointestinal disorders Nausea 2 (1.1%) 11 (2.7%) 6 (2.5%) Infections and infestations Nasopharyngitis 16 (9.1%) 27 (6.6%) 17 (7.0%) Sinusitis 2 (1.1%) 20 (4.9%) 5 (2.1%) Upper respiratory tract infection 2 (1.1%) 14 (3.4%) 5 (2.1%) Viral upper respiratory tract infection 4 (2.3%) 2 (0.5%) (0.0%) Musculoskeletal and connective tissue disorders Arthralgia 5 (2.9%) 12 (2.9%) 1 (0.4%) Nervous system disorders Headache 21 (12.0%) 25 (6.1%) 7 (2.9%) Respiratory, thoracic, and mediastinal disorders Cough 2 (1.1%) 9 (2.2%) 3 (1.2%) Additional reactions reported during the 24 week treatment period in Trials 1 and 3 [≥2% of patients receiving Xolair (150 or 300 mg) and more frequently than those receiving placebo] included: toothache, fungal infection, urinary tract infection, myalgia, pain in extremity, musculoskeletal pain, peripheral edema, pyrexia, migraine, sinus headache, anxiety, oropharyngeal pain, asthma, urticaria, and alopecia. Injection Site Reactions Injection site reactions of any severity occurred during the studies in more Xolair-treated patients [11 patients (2.7%) at 300 mg, 1 patient (0.6%) at 150 mg] compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding and urticaria. None of the events resulted in study discontinuation or treatment interruption. Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma A 5-year observational cohort study was conducted in patients ≥ 12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of Xolair, including the risk of malignancy [see Warnings and Precautions (5.2) ]. A total of 5007 Xolair-treated and 2829 non-Xolair-treated patients enrolled in the study. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More Xolair-treated patients were diagnosed with severe asthma (50%) compared to the non-Xolair-treated patients (23%) and 44% of patients prematurely discontinued the study. Additionally, 88% of patients in the Xolair-treated cohort had been previously exposed to Xolair for a mean of 8 months. A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in Xolair-treated patients (13.4) compared to non-Xolair-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 versus 0.1), myocardial infarction (2.1 versus 0.8), pulmonary hypertension (0.5 versus 0), pulmonary embolism/venous thrombosis (3.2 versus 1.5), and unstable angina (2.2 versus 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with Xolair. However, the observational study design, the inclusion of patients previously exposed to Xolair (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. A pooled analysis of 25 randomized double-blind, placebo-controlled clinical trials of 8 to 52 weeks in duration was conducted to further evaluate the imbalance in cardiovascular and cerebrovascular SAEs noted in the above observational cohort study. A total of 3342 Xolair-treated patients and 2895 placebo-treated patients were included in the pooled analysis. The patients had a mean age of 38 years, and were followed for a mean duration of 6.8 months. No notable imbalances were observed in the rates of cardiovascular and cerebrovascular SAEs listed above. However, the results of the pooled analysis were based on a low number of events, slightly younger patients, and shorter duration of follow-up than the observational cohort study; therefore, the results are insufficient to confirm or reject the findings noted in the observational cohort study. 6.2 Immunogenicity Antibodies to Xolair were detected in approximately 1/1723 (< 0.1%) of patients treated with Xolair in the clinical studies evaluated for approval of asthma in patients 12 years of age and older. In three pediatric studies, antibodies to Xolair were detected in one patient out of 581 patients 6 to <12 years of age treated with Xolair and evaluated for antibodies. There were no detectable antibodies in the patients treated in the phase 3 CIU clinical trials, but due to levels of Xolair at the time of anti-therapeutic antibody sampling and missing samples for some patients, antibodies to Xolair could only have been determined in 88% of the 733 patients treated in these clinical studies. The data reflect the percentage of patients whose test results were considered positive for antibodies to Xolair in ELISA assays and are highly dependent on the sensitivity and specificity of the assays. Additionally, the observed incidence of antibody positivity in the assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. Therefore, comparison of the incidence of antibodies to Xolair with the incidence of antibodies to other products may be misleading. 6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Xolair in adult and adolescent patients 12 years of age and older. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylaxis: Based on spontaneous reports and an estimated exposure of about 57,300 patients from June 2003 through December 2006, the frequency of anaphylaxis attributed to Xolair use was estimated to be at least 0.2% of patients. Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to Xolair administration with no other identifiable cause. Signs and symptoms in these reported cases included bronchospasm, hypotension, syncope, urticaria, angioedema of the throat or tongue, dyspnea, cough, chest tightness, and/or cutaneous angioedema. Pulmonary involvement was reported in 89% of the cases. Hypotension or syncope was reported in 14% of cases. Fifteen percent of the reported cases resulted in hospitalization. A previous history of anaphylaxis unrelated to Xolair was reported in 24% of the cases. Of the reported cases of anaphylaxis attributed to Xolair, 39% occurred with the first dose, 19% occurred with the second dose, 10% occurred with the third dose, and the rest after subsequent doses. One case occurred after 39 doses (after 19 months of continuous therapy, anaphylaxis occurred when treatment was restarted following a 3 month gap). The time to onset of anaphylaxis in these cases was up to 30 minutes in 35%, greater than 30 and up to 60 minutes in 16%, greater than 60 and up to 90 minutes in 2%, greater than 90 and up to 120 minutes in 6%, greater than 2 hours and up to 6 hours in 5%, greater than 6 hours and up to 12 hours in 14%, greater than 12 hours and up to 24 hours in 8%, and greater than 24 hours and up to 4 days in 5%. In 9% of cases the times to onset were unknown. Twenty-three patients who experienced anaphylaxis were rechallenged with Xolair and 18 patients had a recurrence of similar symptoms of anaphylaxis. In addition, anaphylaxis occurred upon rechallenge with Xolair in 4 patients who previously experienced urticaria only. Eosinophilic Conditions: Eosinophilic conditions have been reported [see Warnings and Precautions (5.5) ]. Fever, Arthralgia, and Rash: A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of Xolair [see Warnings and Precautions (5.6) ]. Hematologic: Severe thrombocytopenia has been reported. Skin: Hair loss has been reported.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For subcutaneous (SC) administration only. (2.1, 2.2) Divide doses of more than 150 mg among more than one injection site to limit injections to not more than 150 mg per site. (2.4) Asthma: Xolair 75 to 375 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. (2.1) Chronic Idiopathic Urticaria: Xolair 150 or 300 mg SC every 4 weeks. Dosing in CIU is not dependent on serum IgE level or body weight. (2.2) 2.1 Dosage for Asthma Administer Xolair 75 to 375 mg by subcutaneous injection every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). Adjust doses for significant changes in body weight during treatment (see Table 1, 2 and 3). Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination. Interruptions lasting less than one year: Dose based on serum IgE levels obtained at the initial dose determination. Interruptions lasting one year or more: Re-test total serum IgE levels for dose determination using Table 1, 2, or 3 based on the patient's age. Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control. Adult and adolescent patients 12 years of age and older: Initiate dosing according to Table 1 or 2. Table 1. Subcutaneous Xolair Doses Every 4 Weeks for Patients 12 Years of Age and Older with Asthma Pre-treatment Serum IgE Body Weight 30–60 kg > 60–70 kg > 70–90 kg > 90–150 kg ≥ 30–100 IU/mL 150 mg 150 mg 150 mg 300 mg > 100–200 IU/mL 300 mg 300 mg 300 mg > 200–300 IU/mL 300 mg > 300–400 IU/mL SEE TABLE 2 > 400–500 IU/mL > 500–600 IU/mL Table 2. Subcutaneous Xolair Doses Every 2 Weeks for Patients 12 Years of Age and Older with Asthma Pre-treatment Serum IgE Body Weight 30–60 kg > 60–70 kg > 70–90 kg > 90–150 kg ≥ 30–100 IU/mL SEE TABLE 1 > 100–200 IU/mL 225 mg > 200–300 IU/mL 225 mg 225 mg 300 mg > 300–400 IU/mL 225 mg 225 mg 300 mg > 400–500 IU/mL 300 mg 300 mg 375mg > 500–600 IU/mL 300 mg 375 mg DO NOT DOSE > 600–700 IU/mL 375 mg Pediatric patients 6 to <12 years of age: Initiate dosing according to Table 3. Table 3. Subcutaneous Xolair Doses Every 2 or 4 Weeks* for Pediatric Patients with Asthma Who Begin Xolair Between the Ages of 6 to <12 Years Table 3 2.2 Dosage for Chronic Idiopathic Urticaria Administer Xolair 150 or 300 mg by subcutaneous injection every 4 weeks. Dosing of Xolair in CIU patients is not dependent on serum IgE (free or total) level or body weight. The appropriate duration of therapy for CIU has not been evaluated. Periodically reassess the need for continued therapy. 2.3 Reconstitution The supplied Xolair lyophilized powder must be reconstituted with Sterile Water for Injection (SWFI) USP, using the following instructions: 1)Before reconstitution, determine the number of vials that will need to be reconstituted (each vial delivers 150 mg of Xolair in 1.2 mL) (see Table 4). 2)Draw 1.4 mL of SWFI, USP, into a 3 mL syringe equipped with a 1 inch, 18-gauge needle. 3)Place the vial upright on a flat surface and using standard aseptic technique, insert the needle and inject the SWFI, USP, directly onto the product. 4)Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder. Do not shake. 5)Gently swirl the vial for 5 to 10 seconds approximately every 5 minutes in order to dissolve any remaining solids. The lyophilized product takes 15 to 20 minutes to dissolve. If it takes longer than 20 minutes to dissolve completely, gently swirl the vial for 5 to 10 seconds approximately every 5 minutes until there are no visible gel-like particles in the solution. Do not use if the contents of the vial do not dissolve completely by 40 minutes. 6)After reconstitution, Xolair solution is somewhat viscous and will appear clear or slightly opalescent. It is acceptable if there are a few small bubbles or foam around the edge of the vial; there should be no visible gel-like particles in the reconstituted solution. Do not use if foreign particles are present. 7)Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper. 8) Use the Xolair solution within 8 hours following reconstitution when stored in the vial at 2 to 8ºC (36 to 46ºF), or within 4 hours of reconstitution when stored at room temperature. Reconstituted Xolair vials should be protected from sunlight. 9)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 of 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 of the solution from the inverted vial. 10)Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection. 11)Expel air, large bubbles, and any excess solution in order to obtain a volume of 1.2 mL corresponding to a dose of 150 mg of Xolair. To obtain a volume of 0.6 mL corresponding to a dose of 75 mg of Xolair, 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. 2.4 Administration Administer Xolair by subcutaneous injection. The injection may take 5-10 seconds to administer because the solution is slightly viscous. Do not administer more than 150 mg (contents of one vial) per injection site. Divide doses of more than 150 mg among two or more injection sites (Table 4). Table 4. Number of Vials, Injections and Total Injection Volumes Xolair DoseAll doses in the table are approved for use in asthma patients. The 150 mg and 300 mg Xolair doses are intended for use in CIU patients. Number of vials Number of Injections Total Volume Injected 75 mg 1 1 0.6 mL 150 mg 1 1 1.2 mL 225 mg 2 2 1.8 mL 300 mg 2 2 2.4 mL 375mg 3 3 3.0 mL
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary The data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk. Monoclonal antibodies, such as omalizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy. In animal reproduction studies, no evidence of fetal harm was observed in Cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 10 times the maximum recommended human dose (MRHD) [see Animal Data]. In the US general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Animal Data Reproductive studies have been performed in Cynomolgus monkeys. There was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 10 times the MHRD (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). Omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing. 8.2 Lactation Risk Summary There is no information regarding the presence of omalizumab in human milk, the effects on the breastfed infant, or the effects on milk production. However, omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts. In Cynomolgus monkeys, neonatal serum levels of omalizumab after in utero exposure and 28 days of nursing were between 11% and 94% of the maternal serum level. Levels of omalizumab in milk were 0.15% of maternal serum concentration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Xolair and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition. 8.4 Pediatric Use Asthma Safety and efficacy of Xolair for asthma were evaluated in 2 trials in 926 (Xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen. One trial was a pivotal trial of similar design and conduct to that of adult and adolescent Asthma Trials 1 and 2. The other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. In the pivotal trial, Xolair-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose) [see Clinical Studies (14.1) ]. Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. Chronic Idiopathic Urticaria The safety and effectiveness of Xolair for adolescent patients with CIU were evaluated in 39 patients 12 to 17 years of age (Xolair 29, placebo 10) included in three randomized, placebo-controlled CIU trials. A numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older. Safety and efficacy in pediatric patients with CIU below 12 years of age have not been established. 8.5 Geriatric Use In clinical studies 134 asthma patients and 37 CIU phase 3 study patients 65 years of age or older were treated with Xolair. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

Interactions

7 DRUG INTERACTIONS No formal drug interaction studies have been performed with Xolair. In patients with asthma the concomitant use of Xolair and allergen immunotherapy has not been evaluated. In patients with CIU the use of Xolair in combination with immunosuppressive therapies has not been studied. No formal drug interaction studies have been performed. (7)

More information

Category Value
Authorisation number BLA103976
Agency product number 2P471X1Z11
Orphan designation No
Product NDC 50242-040
Date First Approved 20-03-2006
Date Last Revised 09-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1657212
Storage and handling Xolair should be shipped at controlled ambient temperature (≤ 30°C [ ≤ 86°F]). Store Xolair under refrigerated conditions 2 to 8°C (36 to 46°F). Do not use beyond the expiration date stamped on carton. Use the solution for subcutaneous administration within 8 hours following reconstitution when stored in the vial at 2 to 8°C (36 to 46°F), or within 4 hours of reconstitution when stored at room temperature. Reconstituted Xolair vials should be protected from direct sunlight.
Marketing authorisation holder Genentech, Inc.
Warnings WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after Xolair administration. Health care providers administering Xolair should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.3) ]. WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred after the first dose of Xolair but also has occurred beyond 1 year after beginning treatment. Closely observe patients for an appropriate period of time after Xolair administration and be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. (5.1)