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Ilaris

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Canakinumab is a recombinant humanized monoclonal antibody that specifically targets interleukin-1β (IL-1β) and belongs to the IgG1/κ subtype.

1. Drug name and main ingredients

1. Generic name :Canakinumab (Canakinumab)

2. Trade name :ILARIS®

3. Dosage form : Lyophilized powder for subcutaneous injection

4. Main ingredients : Each bottle contains 180 mg canakinumab (active ingredient), and excipients are sucrose, L-histidine, polysorbate 80, etc.

2. Indications

Cryopyroline-associated periodic syndrome (CAPS) : Suitable for the treatment of CAPS in adults and children aged 4 years and above, including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS).

3. Specifications and properties of

1. Specifications of : 180mg/bottle (single dose 6mL glass bottle of freeze-dried powder).

2. Characteristics : White freeze-dried powder, after reconstitution, it becomes a colorless to light brown clear or slightly opalescent solution with no visible particles.

IV. Usage and Dosage

1. Recommended dosage of : 150mg each time for patients weighing >40kg, 2mg/kg each time for patients weighing 15-40kg (can be increased to 3mg/kg if the efficacy is insufficient), subcutaneous injection once every 8 weeks.

2. Reconstitution method : Dissolve each bottle slowly with 1 mL of sterile water for injection, shake gently at a 45° angle for 1 minute, and let stand for 15 minutes to avoid shaking. Use within 60 minutes after reconstitution or use within 4 hours of refrigeration (2-8°C).

3. Treatment of missed doses : Skip if more than 12 hours, the next dose will be administered according to the original plan; there is no need to take another dose after vomiting.

5. Dose adjustment

1. Weight adjustment : Children 15-40kg start with 2mg/kg, which can be increased to 3mg/kg;

2. Combined use of the strong CYP3A inhibitor : needs to be reduced.

6. Precautions for medication

1. Risk of infection : Screen for latent tuberculosis before treatment and avoid medication during active infection period;

2. Vaccination : Live vaccines are prohibited, and recommended vaccinations must be completed before treatment;

3. Reconstitution : Strict aseptic operation to avoid injection into scar tissue.

7. Medication for special groups

1. Pregnant women : Use only when necessary (animal experiments show delayed fetal bone development);

2. U200c during lactation: Use with caution (unknown whether it is secreted by breast milk);

3. Children : It is safe and effective for ≥4 years old, and there is insufficient data for <4 years old.

8. Adverse reactions

1. Common (≥10%) : Nasopharyngitis (34%), diarrhea (20%), runny nose Sensation (17%), headache (14%), nausea (14%);

2. Severe reactions : Dizziness (9-14%), serious infection (3%).

9. Contraindications

There are no absolute contraindications, but it is prohibited for those who are allergic to the ingredients.

10. Drug interactions

1. TNF inhibitor : Combined use increases the risk of serious infection, avoid combined use;

2. CYP450 substrate : The dosage of narrow therapeutic index drugs such as warfarin may need to be adjusted.

11. Storage method

Keep unopened bottles refrigerated at 2-8°C and away from light. After reconstitution, use within 1 hour at room temperature or within 4 hours of refrigeration.

12. Manufacturer

Manufacturer : Novartis Pharma Stein AG, Switzerland.

Note : If persistent infection, severe dizziness or allergic reaction occurs, seek medical attention immediately.