Canakinumab detailed instructions

1. Indications and Usage

Canakinumab(Canakinumab) is an interleukin-1β blocker, suitable for the treatment of the following diseases:

• Periodic fever syndrome:

- Cryogenic protein-associated periodic syndrome (CAPS), applicable to adults and children 4 years old and above, including :

◾Familial cold autoinflammatory syndrome (FCAS)

◾Markle-Wells Syndrome

- Adult and Pediatric Patients with Tumor Necrosis Factor Receptor-Associated Periodic Syndrome

- HyperimmunoglobulinD syndromeHIDS) mevalonate kinase deficiency (MKD) in adults and children

- Familial Mediterranean fever (FMF) in adults and children

• Active Still's disease, including adult Still's diseaseAOSD and systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older

• Gout flare-ups in adults for whom nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, cannot be tolerated, or do not provide an adequate response, and in adults who are not candidates for repeated courses of corticosteroids

2. Dosage and Administration

• Cryptoprotein-associated periodic syndrome:The recommended weight-based dosage is:

-For patients > 40kg:subcutaneous injection of 150mg every 8 weeks

-for≥ For patients 15 kg and < 40 kg: : 2 mg/kg every 8 weeks. In pediatric patients who weigh 15 to 40kg and have an inadequate response, the dose may be increased to 3 mg/kg.

• Traps, HIDS/MKD, and FMF:The recommended weight-based dosage is :

-For patients >40 kg: The starting dose is 150 mg subcutaneously every 4 weeks. If clinical response is inadequate, the dose may be increased to 300 mg every 4weeks.

-For patients ≤ 40 kg: The starting dose is 2 mg/kg subcutaneously every 4 weeks. If clinical response is inadequate, the dose may be increased to 4 mg/kg every 4weeks.

Still's disease (AOSD and SJIA):For≥ 7.5 kgFor patients, the recommended weight-based dose is 4 mg/kg (maximum dose 300 mg), administered subcutaneously once every 4 weeks.

Gout attack:The recommended dose is150mg subcutaneously. For patients requiring retreatment, at least 12 weeks should elapse before a new dose of canakinumab is administered.

Three. Dosage form and strength

Injection: 150mg/ml solution in a single-dose vial.

Four. Contraindications

Confirmed allergy tocanakinumab or any excipients.

Five. Warnings and Precautions

Serious infections: Canakinumab is associated with an increased incidence of serious infections. Caution should be exercised when usingILARISin patients with a history of infection, a history of recurrent infections, or potentially susceptible infectious diseases. Discontinue canakinumab if the patient develops a serious infection. Avoid giving canakinumab to patients during an active infection requiring medical intervention.

Immunization: Avoid simultaneous administration of live vaccines withcanakinumab. Update on all recommended vaccinations before initiatingcanakinumabtreatment.

6. Adverse reactions

Cryogenic protein-related periodic syndrome:The most common adverse reactions (》10%) are nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight gain, musculoskeletal pain, and dizziness. (6)

Traps, HIDS/MKD, and FMF:The most common adverse reactions (≥10%) are injection site reactions and nasopharyngitis. (6)

Still's disease:The most common adverse drug reactions (》10%) are infections (nasopharyngitis and upper respiratory tract infection), abdominal pain, and injection site reactions.

Gout attacks:The most common adverse reactions reported (》2%) were nasopharyngitis, upper respiratory tract infection, urinary tract infection, hypertriglyceridemia, and back pain.

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