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ILARIS® (Canakinumab)

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ILARIS® (Canakinumab) 4 mg/kg (with a maximum of 300 mg) for patients with a body weight greater HIGHLIGHTS OF PRESCRIBING INFORMATION than or equal to 7.5 kg. Administer subcutaneously every 4 weeks. (2.4) These highlights do not include all the information needed to use ILARIS safely and effectively. See full prescribing information for ILARIS. ----------------------DOSAGE FORMS AND STRENGTHS--------------------­ ® For Injection: 150 mg lyophilized powder in single-dose vials for ILARIS (canakinumab) for injection, for subcutaneous use reconstitution. (3) Initial U.S. Approval: 2009 -------------------------RECENT MAJOR CHANGES------------------------------­ --------------------------------CONTRAINDICATIONS----------------------------­ Indications and Usage (1.1) 09/2016 Confirmed hypersensitivity to the active substance or to any of the excipients. (4) Dosage and Administration (2.3, 2.5) 09/2016 Warnings and Precautions, Immunizations (5.4) 07/2016 -------------------------WARNINGS AND PRECAUTIONS---------------------­ • ---------------------------INDICATIONS AND USAGE-----------------------------­ Interleukin-1 blockade may interfere with immune response to infections. Treatment with medications that work through inhibition of IL-1 has been ILARIS is an interleukin-1β blocker indicated for the treatment of: associated with an increased risk of serious infections. ILARIS has been Periodic Fever Syndromes: associated with an increased incidence of serious infections. Physicians • Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children should exercise caution when administering ILARIS to patients with 4 years of age and older including: infections, a history of recurring infections or underlying conditions which . Familial Cold Autoinflammatory Syndrome (FCAS) (1.1) may predispose them to infections. Discontinue treatment with ILARIS if a . Muckle-Wells Syndrome (MWS) (1.1) patient develops a serious infection. Do not administer ILARIS to patients • Tumor Necrosis Factor Receptor Associated Periodic Syndrome during an active infection requiring medical intervention. (5.1) (TRAPS) in adult and pediatric patients. (1.1) • Live vaccines should not be given concurrently with ILARIS. Prior to • Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase initiation of therapy with ILARIS, patients should receive all recommended Deficiency (MKD) in adult and pediatric patients (1.1) vaccinations. (5.4) • Familial Mediterranean Fever (FMF) in adult and pediatric patients. (1.1) -------------------------------ADVERSE REACTIONS-----------------------------­ Active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years CAPS: The most common adverse reactions greater than 10% reported by and older (1.2) patients treated with ILARIS are nasopharyngitis, diarrhea, influenza, rhinitis, -------------------------DOSAGE AND ADMINISTRATION----------------------­ nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight increased, musculoskeletal pain, and vertigo. (6) • Administer by subcutaneous injection (2.1) Cryopyrin-Associated Periodic Syndromes (CAPS) TRAPS, HIDS/MKD, and FMF: The most common adverse reactions 150 mg for CAPS patients with body weight greater than 40 kg and 2 mg/kg for greater than 10% reported by patients treated with ILARIS are injection site CAPS patients with body weight greater than or equal to 15 kg and less than or reactions and nasopharyngitis. (6) equal to 40 kg. For children 15 to 40 kg with an inadequate response, the dose SJIA: The most common adverse drug reactions greater than 10% reported by can be increased to 3 mg/kg. Administer subcutaneously every 8 weeks. (2.2) patients treated with ILARIS are infections (nasopharyngitis and upper Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), respiratory tract infections), abdominal pain and injection site reactions. (6) Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency To report SUSPECTED ADVERSE REACTIONS, contact Novartis (MKD), and Familial Mediterranean Fever (FMF) (2.3) Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA­ • Body weight less than or equal to 40 kg 1088 or www.fda.gov/medwatch . The recommended starting dose is 2 mg/kg every 4 weeks. The dose ----------------------------------DRUG INTERACTIONS--------------------------­ can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. No formal drug interaction studies have been conducted with ILARIS. (7) • Body weight greater than 40 kg See 17 for PATIENT COUNSELING INFORMATION and Medication . The recommended starting dose is 150 mg every 4 weeks. The dose Guide can be increased to 300 mg every 4 weeks if the clinical response is not adequate. Revised: 09/2016 Systemic Juvenile Idiopathic Arthritis (SJIA) FULL PRESCRIBING INFORMATION: CONTENTS* 7 DRUG INTERACTIONS 7.1 TNF-Blocker and IL-1 Blocking Agent 1 INDICATIONS AND USAGE 7.2 Immunization 1.1 Periodic Fever Syndromes 7.3 Cytochrome P450 Substrates 1.2 Systemic Juvenile Idiopathic Arthritis (SJIA) 8 USE IN SPECIFIC POPULATIONS 2 DOSAGE AND ADMINISTRATION 8.1 Pregnancy 2.1 General Dosing Information 8.2 Lactation 2.2 Cryopyrin-Associated Periodic Syndromes (CAPS) 8.4 Pediatric Use 2.3 Tumor Necrosis Factor Receptor Associated Periodic Fever 8.5 Geriatric Use Syndrome (TRAPS), Hyperimmunoglobulin D 8.6 Patients with Renal Impairment Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD), and 8.7 Patients with Hepatic Impairment Familial Mediterranean Fever (FMF) 10 OVERDOSAGE 2.4 Systemic Juvenile Idiopathic Arthritis (SJIA) 11 DESCRIPTION 2.5 Preparation and Administration of ILARIS Lyophilized 12 CLINICAL PHARMACOLOGY Powder 12.1 Mechanism of Action 3 DOSAGE FORMS AND STRENGTHS 12.2 Pharmacodynamics 4 CONTRAINDICATIONS 12.3 Pharmacokinetics 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY 5.1 Serious Infections 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.2 Immunosuppression 14 CLINICAL STUDIES 5.3 Hypersensitivity 14.1 Treatment of CAPS 5.4 Immunizations 14.2 Treatment of Periodic Fever Syndromes TRAPS, 5.5 Macrophage Activation Syndrome HIDS/MKD, and FMF 6 ADVERSE REACTIONS 14.3 Treatment of SJIA 6.1 Clinical Trial Experience 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Hypersensitivity 17 PATIENT COUNSELING INFORMATION 6.3 Immunogenicity 6.4 Laboratory Findings Reference ID: 3989830 * Sections or subsections omitted from the full prescribing information are not listed Reference ID: 3989830 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Periodic Fever Syndromes ILARIS (canakinumab) is an interleukin-1β blocker indicated for the treatment of the following autoinflammatory Periodic Fever Syndromes: Cryopyrin-Associated Periodic Syndromes (CAPS) ILARIS is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older including: • Familial Cold Autoinflammatory Syndrome (FCAS) • Muckle-Wells Syndrome (MWS) Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) ILARIS is indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients. Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) ILARIS is indicated for the treatment of Hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients. Familial Mediterranean Fever (FMF) ILARIS is indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients. 1.2 Systemic Juvenile Idiopathic Arthritis (SJIA) ILARIS is indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. 2 DOSAGE AND ADMINISTRATION 2.1 General Dosing Information INJECTION FOR SUBCUTANEOUS USE ONLY. 2.2 Cryopyrin-Associated Periodic Syndromes (CAPS) The recommended dose of ILARIS is 150 mg for CAPS patients with body weight greater than 40 kg. For CAPS patients with body weight greater than or equal to 15 kg and less than or equal to 40 kg, the recommended dose is 2 mg/kg. For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg. ILARIS is administered every eight weeks. 2.3 Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF) The recommended dose of ILARIS for TRAPS, HIDS/MKD, and FMF patients is based on body weight. For patients with body weight less than or equal to 40 kg, the recommended dose is 2 mg/kg administered every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. For patients with body weight greater than 40 kg, the recommended dose is 150 mg administered every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate. 2.4 Systemic Juvenile Idiopathic Arthritis (SJIA) The recommended dose of ILARIS for SJIA patients with a body weight greater than or equal to 7.5 kg is 4 mg/kg (with a maximum of 300 mg) administered every 4 weeks. Reference ID: 3989830 2.5 Preparation and Administration of ILARIS Lyophilized Powder STEP 1: Using aseptic technique, reconstitute each vial of ILARIS lyophilized powder by slowly injecting 1 mL of Sterile Water for Injection with a 1-mL syringe and an 18-gauge x 2” needle. STEP 2: Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for 5 minutes. Do not shake. Then gently turn the vial
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