canakinumab (Rx)

Brand and Other Names:Ilaris
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 180mg/vial (150mg/mL after reconstitution)
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Cryopyrin-Associated Periodic Syndrome

Indicated for treatment of cryopyrin-associated periodic syndrome (CAPS), including familial old autoinflammatory syndrome and Muckle-Wells syndrome in adults and children

>40 kg: 150 mg SC q8wk

15-40 kg: 2 mg/kg SC q8wk; may increase to 3 mg/kg if inadequate response 

Tumor Necrosis Factor Receptor-Associated Periodic Syndrome

Indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients

150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate

Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency

Indicated for the treatment of hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS) (HIDS)/mevalonate kinase deficiency (MKD) in adult and pediatric patients

150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate

Familial Mediterranean Fever

Indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients

150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate

Still Disease (Orphan)

Orphan designation for treatment of adult-onset Still disease

Sponsor

  • Novartis Pharmaceuticals Corporation; One Health Plaza; East Hanover, New Jersey 07936

Dosage Forms & Strengths

powder for injection

  • 180mg/vial (150mg/mL after reconstitution)
more...

Cryopyrin-Associated Periodic Syndrome

Indicated for treatment of cryopyrin-associated periodic syndrome, including familial old autoinflammatory syndrome and Muckle-Wells syndrome in adults and children

<4 years

  • Safety and efficacy not established

≥4 Years

  • 15-40 kg: 2 mg/kg SC q8wk 
  • ≥40 kg: 150 mg SC q8wk

Tumor Necrosis Factor Receptor-Associated Periodic Syndrome

Indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients

≤40 kg: 2 mg/kg SC q4wk; may increase to 4 mg/kg q4wk if the clinical response is not adequate 

>40 kg: 150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate

Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency

Indicated for the treatment of hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS) (HIDS)/mevalonate kinase deficiency (MKD) in adult and pediatric patients

≤40 kg: 2 mg/kg SC q4wk; may increase to 4 mg/kg q4wk if the clinical response is not adequate 

>40 kg: 150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate

Familial Mediterranean Fever

Indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients

≤40 kg: 2 mg/kg SC q4wk; may increase to 4 mg/kg q4wk if the clinical response is not adequate 

>40 kg: 150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate

Systemic Juvenile Idiopathic Arthritis

Indicated for active SJIA

<2 years: Safety and efficacy not established

≥2 years and weight ≥7.5 kg: 4 mg/kg SC qMonth; not to exceed 300 mg/dose

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Interactions

Interaction Checker

and canakinumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
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            Adverse Effects

            >10%

            Bronchitis (11%)

            Diarrhea (20%)

            Gastroenteritis (11%)

            Headache (14%)

            Influenza (17%)

            Musculoskeletal pain (11%)

            Nasopharyngitis (34%)

            Nausea (14%)

            Pharyngitis (11%)

            Rhinitis (17%)

            Weight increase (11%)

            Vertigo (11%)

            1-10%

            Inj site pain (9%)

            Decrease in calcium (4-8%)

            Increase eosinophilis (3-7%)

            Increase in ALT (3%)

            Increase in bilirubin (3-7%)

            Creatinine clearance (3-8%)

            Proteinuria (4-8%)

            < 1%

            Hypersensitivity reactions

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            Warnings

            Contraindications

            Active serious infection

            Concomitant live vaccines

            Hypersensitivity

            Cautions

            Concomitant use of TNF-alpha or IL-1 antagonists

            Risk of infections, reactivation of latent hepatitis/TB; interrupt if serious infection develops

            Increase risk of lymphoma

            May impair defenses against malignancies

            MWS: increase risk of vertigo

            Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop with rheumatic conditions, particularly SJIA; based on clinical trials, canakinumab did not increase incidence of MAS

            Infections, predominantly of upper respiratory tract, in some instances serious, reported in isolated cases of unusual or opportunistic infections including aspergillosis, atypical mycobacterial infections, cytomegalovirus, herpes zoster; causal relationship of therapy to infections cannot be excluded

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            Pregnancy & Lactation

            Pregnancy: The limited human data from postmarketing reports on use of therapy in pregnant women are not sufficient to inform a drug associated risk; monoclonal antibodies, such as canakinumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential fetal exposure is likely to be greater during the second and third trimesters of pregnancy

            Lactation: There is no information regarding the presence of canakinumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk; the effects of canakinumab in breast milk and possible systemic exposure in the breastfed infant are unknown; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant, human monoclonal antibody that reduces inflammation by inhibiting to interleukin-1-beta and preventing its interaction with cell surface receptors;

            Pharmacokinetics

            Bioavailability: 66%

            Peak plasma time: 2-7 days (children); 7 days (adults)

            Peak plasma concentration: 16 +/- 3.5 mcg/mL

            Vd: 6 L

            Half-life: 26 days

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            Administration

            SC Preparation

            Reconstitute lyophilized powder with 1 mL sterile water for injection to obtain 150 mg/mL solution

            Swirl the vial slowly at an angle of about 45° for ~1 minute and allow to stand for 5 minutes

            Do not shake; gently turn the vial upside down and back again 10 times; avoid touching the rubber stopper with your fingers

            Allow stand for 15 minutes at room temperature

            Do not shake

            Do not use if particulate matter is present in the solution

            Tap the side of the vial to remove any residual liquid from the stopper

            The reconstituted solution should be clear to opalescent, colorless to a slightly brownish yellow tint, and essentially free from particulates

            If the solution has a distinctly brown discoloration, do not use

            Slight foaming of the product upon reconstitution is not unusual

            Protect from light

            Reconstituted solution can be kept at room temperature if used within 1 hr; otherwise, refrigerate at 2-8°C (36-46°F) and use within 4 hr

            SC Administration

            Using a sterile 1-mL syringe and needle, carefully withdraw the required volume depending on the dose to be administered and inject SC using a 27-gauge x 0.5-inch needle

            Avoid injecting scar tissue as this may result in insufficient exposure

            Discard any unused product or waste material in accordance with local requirements

            Storage

            Unopened vial

            • Refrigerate at 2-8°C (36-46° F)
            • Do not freeze
            • Store in the original carton to protect from light

            Reconstituted vial

            • Room temperature if used within 1 hr; otherwise, refrigerate at 2-8°C (36-46°F) and use within 4 hr
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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