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ILARIS
Arthritis/rheumatic disorders
Miscellaneous immune disorders
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Drug Name:

ILARIS Rx

Generic Name and Formulations:
Canakinumab 150mg/vial; lyophilized pwd for SC inj after reconstitution; or 150mg/mL soln for SC inj; preservative-free.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for ILARIS:

Systemic juvenile idiopathic arthritis (SJIA) in patients ≥2yrs of age.

Adult:

Not recommended.

Children:

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

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. Patients should receive all recommended vaccines (eg, pneumococcal, influenza) prior to initiating therapy. Macrophage activation syndrome (esp. in SJIA). Pregnancy. Nursing mothers.

Interactions:

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

Pharmacological Class:

Interleukin-1beta blocker.

Adverse Reactions:

Nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, inj site reactions; increased risk of infections, malignancies.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Indications for ILARIS:

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.

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.

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. Patients should receive all recommended vaccines (eg, pneumococcal, influenza) prior to initiating therapy. Macrophage activation syndrome (esp. in SJIA). Pregnancy. Nursing mothers.

Interactions:

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

Pharmacological Class:

Interleukin-1beta blocker.

Adverse Reactions:

Nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, inj site reactions; increased risk of infections, malignancies.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

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