Dosing & Uses
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 (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)
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
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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
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
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.
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
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
Images
Patient Handout
Formulary
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