canakinumab

REMS

Cryopyrin-associated periodic syndromes including familial cold autoinflammatory syndrome and Muckle-Wells syndrome.
Tumor necrosis factor receptor associated periodic syndrome.
Hyperimmunoglobulin D syndrome/mevalonate kinase deficiency.
Familial Mediterranean fever.
Active Still disease, including adult-onset Still disease and systemic juvenile idiopathic arthritis.
Gout flares when NSAIDs and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and when repeated courses of corticosteroids are not appropriate.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

Active untreated infection, history of recurrent infections, or conditions increasing the propensity of infections;
OB: Use during pregnancy only if clearly needed;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children <2 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)

EENT: nasopharyngitis

GI: diarrhea, nausea, gastroenteritis

Local: injection site reactions

Metab: weight gain

MS: musculoskeletal pain

Neuro: headache, vertigo

Resp: bronchitis

Misc: influenza, hypersensitivity reactions, INFECTION, MACROPHAGE ACTIVATION SYNDROME

Interactions ⬆ ⬇

Drug-drug:

Avoid concurrent use of live vaccines; all vaccinations should be completed prior to treatment.
Concurrent use with tumor necrosis factor inhibitors may ↑ risk of serious infections.
May alter activity of CYP450 substrates, including warfarin; careful monitoring of such drugs with narrow therapeutic indices should be undertaken.

Availability ⬆ ⬇

Solution for injection: 150 mg/mL

Route/Dosage ⬆ ⬇

Cryopyrin-Associated Periodic Syndromes

SC (Adults >40 kg): 150 mg every 8 wk.
SC (Adults and Children 15–40 kg): 2 mg/kg every 8 wk; may be ↑ to 3 mg/kg every 8 wk if response inadequate.

Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, and Familial Mediterranean Fever

SC (Adults >40 kg): 150 mg every 4 wk; may be ↑ to 300 mg every 4 wk if inadequate response.
SC (Adults and Children ≤40 kg): 2 mg/kg every 4 wk; may be ↑ to 4 mg/kg every 4 wk if inadequate response.

Still Disease (Adult-Onset Still Disease and Systemic Juvenile Idiopathic Arthritis

SC (Adults and Children ≥2 yr and ≥7.5 kg): 4 mg/kg (max dose = 300 mg) every 4 wk.

Gout Flares

SC (Adults ): 150 mg as single dose. If retreatment necessary, wait ≥12 wk before administering another dose.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds and neutralizes the activity of interleukin (IL)-1β by blocking its interaction with IL-1 receptors.

Therapeutic effects:

Decreased flares of disease symptoms.
Reduction in pain associated with gout flares and in risk of new gout flares.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: interleukin antagonists

Pharmacokinetics ⬆ ⬇

Absorption: 70% absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 26 days.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 8 days‡	7 days‡	8 wk

‡Noted as normalization of markers of inflammation.

‡Blood levels.

Patient/Family Teaching ⬆ ⬇

Instruct patient to read Medication Guide prior to starting therapy.
May cause vertigo. Caution patient to avoid driving and other activities requiring alertness until response to canakinumab is known.
Advise patient to notify health care professional immediately if signs of infection (fever, sore throat, dyspnea) or macrophage activation syndrome (fever lasting >3 days, persistent cough, redness in one part of body, warm feeling or swelling of skin) occur.
Inform patient to avoid receiving live vaccines during therapy.
May cause injection site reactions (pain, erythema, swelling, pruritus, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, hemorrhage). Notify health care professional if reaction is persistent.
Advise patient to notify health care professional if signs and symptoms of hypersensitivity reactions (difficulty breathing or swallowing, nausea, dizziness, skin rash, itching, hives, palpitations, low BP) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. May interfere with immune response; consider risks and benefits before administering live vaccines to infants exposed to canakinumab in utero for ≥4–12 mo after mother's last dose.

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Indications ⬇