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XOLAIR Prescribing Information HIGHLIGHTS OF PRESCRIBING INFORMATION measured before the start of treatment, and body weight (kg). See the dose determination charts. (2.3) These highlights do not include all the information needed to use XOLAIR safely and effectively. See full prescribing information for Chronic Spontaneous Urticaria: XOLAIR 150 or 300 mg SC every XOLAIR. 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight. (2.4) ® XOLAIR (omalizumab) injection, for subcutaneous use ----------------------DOSAGE FORMS AND STRENGTHS--------------------- ® XOLAIR (omalizumab) for injection, for subcutaneous use Injection: 75 mg/0.5 mL and 150 mg/mL solution in a single-dose Initial U.S. Approval: 2003 prefilled syringe (3) For Injection: 150 mg lyophilized powder in a single-dose vial for WARNING: ANAPHYLAXIS reconstitution (3) See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, ------------------------------CONTRAINDICATIONS------------------------------- urticaria, and/or angioedema of the throat or tongue, has been reported Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (4, to occur after administration of XOLAIR. Anaphylaxis has occurred 5.1) after the first dose of XOLAIR but also has occurred beyond 1 year after -----------------------WARNINGS AND PRECAUTIONS------------------------ 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 administration and be prepared to manage anaphylaxis which can be life- manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration. (5.1) threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Malignancy: Malignancies have been observed in clinical studies. (5.2) Selection of patients for self-administration of XOLAIR should be based Acute Asthma Symptoms: Do not use for the treatment of acute on criteria to mitigate risk from anaphylaxis. (2.5, 5.1, 6.1, 6.3) bronchospasm or status asthmaticus. (5.3) Corticosteroid Reduction: Do not abruptly discontinue corticosteroids ---------------------------RECENT MAJOR CHANGES--------------------------- upon initiation of XOLAIR therapy. (5.4) Boxed Warning 04/2021 Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, Indications and Usage (1.1, 1.2) 04/2021 worsening pulmonary symptoms, cardiac complications, and/or Dosage and Administration (2.1, 2.3, 2.5, 2.6, 2.7) 04/2021 neuropathy, especially upon reduction of oral corticosteroids. (5.5) Warnings and Precautions (5.1, 5.3, 5.4, 5.8) 04/2021 Fever, Arthralgia, and Rash: Stop XOLAIR if patients develop signs and symptoms similar to serum sickness. (5.6) ----------------------------INDICATIONS AND USAGE--------------------------- ------------------------------ADVERSE REACTIONS------------------------------ XOLAIR is an anti-IgE antibody indicated for: Asthma: The most common adverse reactions (≥ 1% of patients) in clinical Moderate to severe persistent asthma in adults and pediatric patients 6 studies with adult and adolescent patients ≥12 years of age were arthralgia, years of age and older with a positive skin test or in vitro reactivity to a pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, perennial aeroallergen and symptoms that are inadequately controlled dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 with inhaled corticosteroids (1.1) years of age, the most common adverse reactions were nasopharyngitis, Nasal polyps in adult patients 18 years of age and older with inadequate headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis response to nasal corticosteroids, as add-on maintenance treatment (1.2) media, viral gastroenteritis, arthropod bites, and epistaxis. (6.1) Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of Nasal Polyps: The most common adverse reactions (≥ 3% of patients) in age and older who remain symptomatic despite H1 antihistamine clinical studies with adult patients included the following: headache, treatment (1.3) injection site reaction, arthralgia, upper abdominal pain, and dizziness. (6.1) Limitations of Use: Chronic Spontaneous Urticaria: The most common adverse reactions (2% Not indicated for acute bronchospasm or status asthmaticus. (1.1, 5.3) of patients) included the following: nausea, nasopharyngitis, sinusitis, Not indicated for other allergic conditions or other forms of urticaria. (1.1, upper respiratory tract infection, viral upper respiratory tract infection, 1.2) arthralgia, 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: 07/2021 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), FULL PRESCRIBING INFORMATION: CONTENTS* 5.1 Anaphylaxis 5.2 Malignancy WARNING: ANAPHYLAXIS 5.3 Acute Asthma Symptoms and Deteriorating Disease 1 INDICATIONS AND USAGE 5.4 Corticosteroid Reduction 1.1 Asthma 5.5 Eosinophilic Conditions 1.2 Nasal Polyps 5.6 Fever, Arthralgia, and Rash 1.3 Chronic Spontaneous Urticaria (CSU) 5.7 Parasitic (Helminth) Infection 2 DOSAGE AND ADMINISTRATION 5.8 Laboratory Tests 2.1 Overview of Dosage Determination 6 ADVERSE REACTIONS 2.2 Recommended Dosage for Asthma 6.1 Clinical Trials Experience 2.3 Recommended Dosage for Nasal Polyps 6.2 Immunogenicity 2.4 Recommended Dosage for Chronic Spontaneous 6.3 Postmarketing Experience Urticaria (CSU) 7 DRUG INTERACTIONS 2.5 Administration Overview 8 USE IN SPECIFIC POPULATIONS 2.6 XOLAIR Prefilled Syringe 8.1 Pregnancy 2.7 Preparation for Use and Injection of XOLAIR 8.2 Lactation Lyophilized Powder 8.4 Pediatric Use 3 DOSAGE FORMS AND STRENGTHS 8.5 Geriatric Use 4 CONTRAINDICATIONS 11 DESCRIPTION 5 WARNINGS AND PRECAUTIONS 12 CLINICAL PHARMACOLOGY 1 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Asthma 14.2 Nasal Polyps 14.3 Chronic Spontaneous Urticaria (CSU) 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 2 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 Spontaneous Urticaria (CSU) XOLAIR is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous 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, dosing determination should
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