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)

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

Indicated for the treatment of active Still disease, including adult-onset Still disease (AOSD)

4 mg/kg SC q4Weeks; not to exceed 300 mg/dose

Dosage Forms & Strengths

powder for injection

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

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 Still disease and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older

<2 years: Safety and efficacy not established

≥2 years and weight ≥7.5 kg: 4 mg/kg SC q4Weeks; not to exceed 300 mg/dose

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Interactions

Interaction Checker

and canakinumab

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nasopharyngitis (34%)

            Diarrhea (20%)

            Influenza (17%)

            Rhinitis (17%)

            Headache (14%)

            Nausea (14%)

            Vertigo (9-14%)

            Gastroenteritis (11%)

            Pharyngitis (11%)

            Weight increase (11%)

            Bronchitis (11%)

            Musculoskeletal pain (11%)

            WBC count ≤0.8x LLN (10.4%)

            1-10%

            Injection site pain (9%)

            Decreased platelets (6.3%)

            ANC <1x 109/L (6%)

            Increased AST/ALT (4.1%)

            Frequency Not Defined

            Mild bilirubin elevation

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Risk of serious infections, including opportunistic infections and reactivation of latent hepatitis or TB; interrupt therapy if serious infection develops; 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

            Hypersensitivity reported postmarketing; disease symptoms may be similar to symptoms of hypersensitivity; if a severe hypersensitivity reaction occurs, therapy should be discontinued and appropriate therapy initiated

            May impair defenses against malignancies

            Macrophage activation syndrome (MAS) is a life-threatening disorder that may develop with rheumatic conditions, particularly with Still disease or SJIA; it should be aggressively treated; it is important to be attentive to symptoms of infection or worsening of Still’s disease, as these are known triggers for MAS; based on clinical trials, canakinumab did not increase incidence of MAS;

            Drug interaction overview

            • IL-1 or TNF blockers
              • Avoid coadministration
              • Coadministration with other IL-1 antagonists or TNF inhibitors increases risk of neutropenia and serious infection
            • Live vaccines
              • Avoid coadministration
              • Data are not available on effects of live vaccination or secondary infection transmission by live vaccines if administered while on canakinumab
              • Recommended to complete immunization before initiating canakinumab
            • CYP450 substrates
              • CYP450 enzymes are suppressed by increased levels of cytokines (eg, IL-1) during chronic inflammation
              • CYP450 enzymes are expected to normalize once IL-1 levels decrease
              • Monitor CYP450 substrates with narrow therapeutic indices, where the dose is individually adjusted (eg, warfarin); dose adjustment may be necessary
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            Pregnancy & Lactation

            Pregnancy

            Limited human data from postmarketing reports on use 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

            Animal data

            • Studies with marmoset monkeys showed no evidence of embryotoxicity or fetal malformations with during organogenesis and later in gestation at doses that produced exposures ~11 times the exposure at the maximum recommended human dose (MRHD) and greater
            • Delays in fetal skeletal development were observed in marmoset monkeys following prenatal exposure at concentrations ~11 times the MRHD and greater; similar delays in fetal skeletal development were observed in mice administered a murine analog of canakinumab during organogenesis

            Lactation

            Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production

            Human IgG is known to be present in human milk; 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 binds to human interleukin (IL)-1β and neutralizes its activity by blocking its interaction with IL-1 receptors; does not bind IL-1α or IL-1 receptor antagonist (IL-1ra)

            Absorption

            Absolute bioavailability: 66%

            Peak plasma concentration: 16 mcg/mL

            Peak plasma time

            • Adults: ~7 days
            • Pediatric patients: 2-7 days

            Distribution

            Vd (steady-state)

            • CAPS (70-kg patient): 6.01 L
            • SJIA (33-kg patient): 3.2 L
            • Periodic fever syndrome (70-kg patient): 6.34 L

            Elimination

            Clearance

            • CAPS (70-kg patient): 0.174 L/day
            • SJIA (33-kg patient): 0.11 L/day
            • Periodic fever syndrome (70-kg patient): 0.17 L/day

            Half-life

            • Adults, 150-mg dose: 26 days
            • Children and adolescents, 150-mg or 2-mg/kg dose: 22.9-25.7 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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            Formulary

            FormularyPatient Discounts

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

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.