Canakinumab is an IL-1β inhibitor indicated for various autoinflammatory diseases.

I. Common Side Effects of Canakinumab

1. Common Side Effects in CAPS Patients

(1) Side effects with an incidence rate exceeding 10% include: nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight gain, musculoskeletal pain and dizziness.

(2) Dizziness is only observed in MWS patients.

2. Common Side Effects in TRAPS/HIDS/MKD/FMF Patients

Side effects with an incidence rate ≥ 10% are injection site reactions and nasopharyngitis.

3. Common Side Effects in Still’s Disease Patients

Side effects with an incidence rate exceeding 10% include: infections (nasopharyngitis and upper respiratory tract infections), abdominal pain and injection site reactions.

4. Common Side Effects in Patients with Gout Flare

Side effects with an incidence rate exceeding 2% include: nasopharyngitis, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia and back pain.

5. Abnormal Laboratory Findings

(1) Blood routine: Transient decreases in neutrophils, white blood cells and platelets may occur.

(2) Liver function: Elevations in ALT/AST may be observed, which are usually mild and reversible.

(3) Uric acid: A slightly higher proportion of elevated uric acid is seen in gout patients.

(4) Blood lipids: The incidence of hypertriglyceridemia in gout patients is 5.6%.

II. Serious Side Effects and Management

1. Serious Infections

(1) Canakinumab may increase the risk of serious infections, predominantly upper respiratory tract infections.

(2) Seek immediate medical attention if infection symptoms such as fever, cough and fatigue occur.

(3) In the event of a serious infection, discontinue the drug and administer anti-infective treatment.

2. Hypersensitivity Reactions

(1) Anaphylactic shock has not been reported in clinical trials; however, DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) has been observed post-marketing.

(2) Discontinue the drug immediately and seek emergency medical care if rash, itching, dyspnea, or swelling of the face or lips occurs.

3. Immunosuppression

(1) Long-term use may increase the risk of malignancies.

(2) Regular physical examinations are recommended during treatment to monitor for abnormal masses or persistent discomfort.

4. Macrophage Activation Syndrome

(1) Still’s disease patients should be alert to MAS, which manifests as persistent high fever, hepatosplenomegaly, bleeding tendency, etc.

(2) Immediate medical intervention with intensive treatment is required once it occurs.

III. Methods to Alleviate Side Effects

1. Management of Injection Site Reactions

(1) Redness, itching and pain may occur at the injection site, which can be relieved by cold compresses; scratching should be avoided.

(2) Avoid injecting into scar tissue to prevent insufficient drug absorption.

(3) Inform a doctor if the reaction persists or worsens.

2. Infection Prevention and Monitoring

(1) Tuberculosis screening and vaccinations such as pneumococcal and inactivated influenza vaccines should be completed prior to treatment.

(2) Avoid contact with infected individuals during treatment, wash hands frequently, and seek medical advice promptly if signs of infection appear.

(3) Concurrent administration of live vaccines is not recommended.

3. Management of Abnormal Laboratory Parameters

(1) Regular monitoring of blood routine, liver and kidney function, and blood lipids is required.

(2) Most cytopenias are transient and do not require special intervention.

(3) Elevated ALT/AST levels usually resolve spontaneously.

(4) Hypertriglyceridemia can be managed through dietary control (low-fat, low-sugar diet) and pharmacological intervention if necessary.

4. Alleviation of Gastrointestinal Symptoms

(1) Nausea, diarrhea, gastroenteritis and other symptoms can be relieved by small and frequent meals, a bland diet and fluid replacement.

(2) Consult a doctor regarding the need for antiemetic or antidiarrheal medications if symptoms are severe.

5. Management of Dizziness

(1) Dizziness in CAPS patients usually resolves spontaneously with continued treatment.

(2) Avoid driving or operating machinery when dizziness occurs; change positions slowly to prevent falls.

IV. Storage Conditions for Canakinumab

1. Temperature Requirements

(1) Unopened vials must be stored under refrigeration at 2°C to 8°C (36°F to 46°F).

(2) Do not freeze.

2. Light Protection and Packaging

(1) Store in the original carton to protect from light.

(2) Do not use the drug beyond the expiration date printed on the label.

3. Post-Use Disposal

(1) Canakinumab contains no preservatives.

(2) Any unused medicinal solution or waste should be disposed of in accordance with local requirements.

(3) Keep out of the reach of children.