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XOLAIR® (Omalizumab) for Injection NDC 50242-040-62

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XOLAIR® (Omalizumab) for Injection NDC 50242-040-62 measured before the start of treatment, and body weight (kg). See the HIGHLIGHTS OF PRESCRIBING INFORMATION dose determination charts. (2.3) These highlights do not include all the information needed to use • Chronic Idiopathic Urticaria: XOLAIR 150 or 300 mg SC every 4 weeks. XOLAIR safely and effectively. See full prescribing information for Dosing in CIU is not dependent on serum IgE level or body weight. (2.4) XOLAIR. ----------------------DOSAGE FORMS AND STRENGTHS--------------------­ ® XOLAIR (omalizumab) injection, for subcutaneous use • ® Injection: 75 mg/0.5 mL and 150 mg/mL solution in a single-dose XOLAIR (omalizumab) for injection, for subcutaneous use prefilled syringe (3) Initial U.S. Approval: 2003 • For Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution (3) WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. ------------------------------CONTRAINDICATIONS------------------------------­ Anaphylaxis, presenting as bronchospasm, hypotension, syncope, Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (4, urticaria, and/or angioedema of the throat or tongue, has been reported 5.1) to occur after administration of XOLAIR. Anaphylaxis has occurred -----------------------WARNINGS AND PRECAUTIONS-----------------------­ after the first dose of XOLAIR but also has occurred beyond 1 year after • beginning treatment. Initiate XOLAIR therapy in a healthcare setting, Anaphylaxis: Initiate XOLAIR therapy in a healthcare setting prepared to closely observe patients for an appropriate period of time after XOLAIR manage anaphylaxis which can be life-threatening and observe patients administration and be prepared to manage anaphylaxis which can be life- for an appropriate period of time after administration. (5.1) • threatening. Inform patients of the signs and symptoms of anaphylaxis Malignancy: Malignancies have been observed in clinical studies. (5.2) and have them seek immediate medical care should symptoms occur. • Acute Asthma Symptoms: Do not use for the treatment of acute Selection of patients for self-administration of XOLAIR should be based bronchospasm or status asthmaticus. (5.3) • on criteria to mitigate risk from anaphylaxis. (2.5, 5.1, 6.1, 6.3) Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of XOLAIR therapy. (5.4) ---------------------------RECENT MAJOR CHANGES--------------------------­ • Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, Boxed Warning 04/2021 worsening pulmonary symptoms, cardiac complications, and/or Indications and Usage (1.1, 1.2) 04/2021 neuropathy, especially upon reduction of oral corticosteroids. (5.5) Dosage and Administration (2.1, 2.3, 2.5, 2.6, 2.7) 04/2021 • Fever, Arthralgia, and Rash: Stop XOLAIR if patients develop signs and Warnings and Precautions (5.1, 5.4, 5.8) 04/2021 symptoms similar to serum sickness. (5.6) ------------------------------ADVERSE REACTIONS-----------------------------­ ----------------------------INDICATIONS AND USAGE--------------------------­ • Asthma: The most common adverse reactions (≥ 1% of patients) in clinical XOLAIR is an anti-IgE antibody indicated for: studies with adult and adolescent patients ≥12 years of age were arthralgia, • Moderate to severe persistent asthma in adults and pediatric patients 6 pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, years of age and older with a positive skin test or in vitro reactivity to a dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 perennial aeroallergen and symptoms that are inadequately controlled years of age, the most common adverse reactions were nasopharyngitis, with inhaled corticosteroids (1.1) headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis • Nasal polyps in adult patients 18 years of age and older with inadequate media, viral gastroenteritis, arthropod bites, and epistaxis. (6.1) response to nasal corticosteroids, as add-on maintenance treatment (1.2) • Nasal Polyps: The most common adverse reactions (≥ 3% of patients) in • Chronic idiopathic urticaria in adults and adolescents 12 years of age and clinical studies with adult patients included the following: headache, older who remain symptomatic despite H1 antihistamine treatment (1.3) injection site reaction, arthralgia, upper abdominal pain, and dizziness. (6.1) Limitations of Use: • Chronic Idiopathic Urticaria: The most common adverse reactions (≥2% of • Not indicated for acute bronchospasm or status asthmaticus. (1.1, 5.3) patients) included the following: nausea, nasopharyngitis, sinusitis, upper • Not indicated for other allergic conditions or other forms of urticaria. (1.1, respiratory tract infection, viral upper respiratory tract infection, arthralgia, 1.2) headache, and cough. (6.1) -----------------------DOSAGE AND ADMINISTRATION----------------------­ To report SUSPECTED ADVERSE REACTIONS, contact Genentech at For subcutaneous (SC) administration only. (2.2, 2.3, 2.4, 2.5) 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Divide doses of more than 150 mg among more than one injection site to limit injections to not more than 150 mg per site. (2.6, 2.7) -------------------------------DRUG INTERACTIONS----------------------------­ • Asthma: XOLAIR 75 to 375 mg SC every 2 or 4 weeks. Determine No formal drug interaction studies have been performed. (7) dose (mg) and dosing frequency by serum total IgE level (IU/mL), See 17 for PATIENT COUNSELING INFORMATION and Medication measured before the start of treatment, and body weight (kg). See the Guide. dose determination charts. (2.2) Revised: 04/2021 • Nasal Polyps: XOLAIR 75 to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), 5.3 Acute Asthma Symptoms and Deteriorating Disease FULL PRESCRIBING INFORMATION: CONTENTS* 5.4 Corticosteroid Reduction WARNING: ANAPHYLAXIS 5.5 Eosinophilic Conditions 1 INDICATIONS AND USAGE 5.6 Fever, Arthralgia, and Rash 1.1 Asthma 5.7 Parasitic (Helminth) Infection 1.2 Nasal Polyps 5.8 Laboratory Tests 1.3 Chronic Idiopathic Urticaria (CIU) 6 ADVERSE REACTIONS 2 DOSAGE AND ADMINISTRATION 6.1 Clinical Trials Experience 2.1 Overview of Dosage Determination 6.2 Immunogenicity 2.2 Recommended Dosage for Asthma 6.3 Postmarketing Experience 2.3 Recommended Dosage for Nasal Polyps 7 DRUG INTERACTIONS 2.4 Recommended Dosage for Chronic Idiopathic Urticaria 8 USE IN SPECIFIC POPULATIONS 2.5 Administration Overview 8.1 Pregnancy 2.6 XOLAIR Prefilled Syringe 8.2 Lactation 2.7 Preparation for Use and Injection of XOLAIR 8.4 Pediatric Use Lyophilized Powder 8.5 Geriatric Use 3 DOSAGE FORMS AND STRENGTHS 11 DESCRIPTION 4 CONTRAINDICATIONS 12 CLINICAL PHARMACOLOGY 5 WARNINGS AND PRECAUTIONS 12.1 Mechanism of Action 5.1 Anaphylaxis 12.2 Pharmacodynamics 5.2 Malignancy 12.3 Pharmacokinetics 1 Reference ID: 4776622 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Asthma 14.2 Nasal Polyps 14.3 Chronic Idiopathic Urticaria 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 2 Reference ID: 4776622 FULL PRESCRIBING INFORMATION 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, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.5), Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.3)]. 1 INDICATIONS AND USAGE 1.1 Asthma XOLAIR is indicated for adults and pediatric 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. 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 Nasal Polyps XOLAIR is indicated for add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. 1.3 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. Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria. 2 DOSAGE AND ADMINISTRATION 2.1 Overview of Dosage Determination Asthma and Nasal Polyps Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with both asthma and nasal polyps,
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