Ilaris

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Gout
  • Miscellaneous immune disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ilaris Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Canakinumab 150mg/vial; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-1beta blocker.

    How Supplied

    Single-dose vial—1

    Manufacturer

    Novartis Pharmaceuticals Corp

    Generic Availability

    NO

    Mechanism of Action

    Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. It binds to human IL1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra).

    Ilaris Indications

    Indications

    Active Still's disease, including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA).

    Ilaris Dosage and Administration

    Adults and Children

    <2yrs: not established. Avoid injecting into scar tissue. Give as SC inj every 4 weeks. ≥2yrs (≥7.5kg): 4mg/kg; max 300mg.

    Ilaris Contraindications

    Not Applicable

    Ilaris Boxed Warnings

    Not Applicable

    Ilaris Warnings/Precautions

    Warnings/Precautions

    Do not start in patients with active infection; discontinue if serious infection develops. History of recurring infections or conditions that predispose to infection. Test for and treat TB before starting therapy. Discontinue if severe hypersensitivity reaction occurs. Prior to initiation, update all recommended vaccinations according to guidelines (including pneumococcal, influenza). Macrophage activation syndrome (esp. in Still's disease). Pregnancy. Nursing mothers.

    Ilaris Pharmacokinetics

    Absorption

    Peak serum concentration: 16 ± 3.5 mcg/mL (~7 days after SC administration).

    Distribution

    Volume of distribution: 6.01 L (CAPS patient); 3.2 L (SJIA patient); 6.34 L (Periodic Fever Syndrome patient); 7.9 L (patient with gout flares).

    Elimination

    Mean terminal half-life: 26 days. Clearance: 0.174 L/day (CAPS patient); 0.11 L/day (SJIA); 0.17 L/day (Periodic Fever Syndrome patient); 0.23 L/day (patient with gout flares).

    Ilaris Interactions

    Interactions

    Concomitant TNF inhibitors, other IL-1 blockers, live vaccines: not recommended. Monitor warfarin, other agents with narrow therapeutic indexes; may need dose adjustments.

    Ilaris Adverse Reactions

    Adverse Reactions

    Nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, inj site reactions, weight increased, musculoskeletal pain, vertigo, abdominal pain, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia, back pain; increased risk of infections, malignancies.

    Ilaris Clinical Trials

    See Literature

    Ilaris Note

    Not Applicable

    Ilaris Patient Counseling

    See Literature

    Ilaris Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Canakinumab 150mg/vial; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-1beta blocker.

    How Supplied

    Single-dose vial—1

    Manufacturer

    Novartis Pharmaceuticals Corp

    Generic Availability

    NO

    Mechanism of Action

    Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. It binds to human IL1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra).

    Ilaris Indications

    Indications

    Gout flares in adults in whom NSAIDs and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.

    Ilaris Dosage and Administration

    Adult

    Avoid injecting into scar tissue. Give as 150mg SC inj. If re-treatment is required, separate by ≥12 weeks before a new dose is given.

    Children

    Not established.

    Ilaris Contraindications

    Not Applicable

    Ilaris Boxed Warnings

    Not Applicable

    Ilaris Warnings/Precautions

    Warnings/Precautions

    Do not start in patients with active infection; discontinue if serious infection develops. History of recurring infections or conditions that predispose to infection. Test for and treat TB before starting therapy. Discontinue if severe hypersensitivity reaction occurs. Prior to initiation, update all recommended vaccinations according to guidelines (including pneumococcal, influenza). Macrophage activation syndrome (esp. in Still's disease). Pregnancy. Nursing mothers.

    Ilaris Pharmacokinetics

    Absorption

    Peak serum concentration: 16 ± 3.5 mcg/mL (~7 days after SC administration).

    Distribution

    Volume of distribution: 6.01 L (CAPS patient); 3.2 L (SJIA patient); 6.34 L (Periodic Fever Syndrome patient); 7.9 L (patient with gout flares).

    Elimination

    Mean terminal half-life: 26 days. Clearance: 0.174 L/day (CAPS patient); 0.11 L/day (SJIA); 0.17 L/day (Periodic Fever Syndrome patient); 0.23 L/day (patient with gout flares).

    Ilaris Interactions

    Interactions

    Concomitant TNF inhibitors, other IL-1 blockers, live vaccines: not recommended. Monitor warfarin, other agents with narrow therapeutic indexes; may need dose adjustments.

    Ilaris Adverse Reactions

    Adverse Reactions

    Nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, inj site reactions, weight increased, musculoskeletal pain, vertigo, abdominal pain, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia, back pain; increased risk of infections, malignancies.

    Ilaris Clinical Trials

    See Literature

    Ilaris Note

    Not Applicable

    Ilaris Patient Counseling

    See Literature

    Ilaris Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Canakinumab 150mg/vial; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-1beta blocker.

    How Supplied

    Single-dose vial—1

    Manufacturer

    Novartis Pharmaceuticals Corp

    Generic Availability

    NO

    Mechanism of Action

    Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. It binds to human IL1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra).

    Ilaris Indications

    Indications

    Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children ≥4yrs of age including: Familial Cold Autoinflammatory Syndrome (FCAS); Muckle-Wells Syndrome (MWS). Treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF) in adults and children.

    Ilaris Dosage and Administration

    Adults and Children

    Avoid injecting into scar tissue. CAPS: Give as SC inj every 8 weeks. <4yrs: not established. ≥4yrs: (≥15–≤40kg): 2mg/kg; children (15–40kg) with inadequate response: may increase to 3mg/kg; (>40kg): 150mg. TRAPS, HIDS/MKD, FMF: Give as SC inj every 4 weeks. <2yrs: not recommended. ≥2yrs: (≤40kg): 2mg/kg, may increase to 4mg/kg every 4 weeks if inadequate response; (>40kg): 150mg, may increase to 300mg every 4 weeks if inadequate response.

    Ilaris Contraindications

    Not Applicable

    Ilaris Boxed Warnings

    Not Applicable

    Ilaris Warnings/Precautions

    Warnings/Precautions

    Do not start in patients with active infection; discontinue if serious infection develops. History of recurring infections or conditions that predispose to infection. Test for and treat TB before starting therapy. Discontinue if severe hypersensitivity reaction occurs. Prior to initiation, update all recommended vaccinations according to guidelines (including pneumococcal, influenza). Macrophage activation syndrome (esp. in Still's disease). Pregnancy. Nursing mothers.

    Ilaris Pharmacokinetics

    Absorption

    Peak serum concentration: 16 ± 3.5 mcg/mL (~7 days after SC administration).

    Distribution

    Volume of distribution: 6.01 L (CAPS patient); 3.2 L (SJIA patient); 6.34 L (Periodic Fever Syndrome patient); 7.9 L (patient with gout flares).

    Elimination

    Mean terminal half-life: 26 days. Clearance: 0.174 L/day (CAPS patient); 0.11 L/day (SJIA); 0.17 L/day (Periodic Fever Syndrome patient); 0.23 L/day (patient with gout flares).

    Ilaris Interactions

    Interactions

    Concomitant TNF inhibitors, other IL-1 blockers, live vaccines: not recommended. Monitor warfarin, other agents with narrow therapeutic indexes; may need dose adjustments.

    Ilaris Adverse Reactions

    Adverse Reactions

    Nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, inj site reactions, weight increased, musculoskeletal pain, vertigo, abdominal pain, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia, back pain; increased risk of infections, malignancies.

    Ilaris Clinical Trials

    See Literature

    Ilaris Note

    Not Applicable

    Ilaris Patient Counseling

    See Literature

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