Siltuximab For Injection | Castleman’s Disease

Siltuximab Application Scope

Siltuximab, the new and special drug is indicated for the treatment of multicentric Castleman’s disease (MCD) in patients who are human immunodeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative.

Siltuximab Characteristics

• Ingredients: Siltuximab, a monoclonal antibody targeting interleukin-6 (IL-6).
• Properties: A biologic agent that inhibits the action of IL-6, reducing inflammation and the proliferation of affected cells in MCD.
• Specification: 100 mg/5 mL or 400 mg/20 mL per vial.
• Packaging Specification: Single-use glass vials with protective caps.
• Storage: Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
• Expiry Date: Typically 24 months from the date of manufacture when stored under proper conditions.
• Executive Standard: In compliance with FDA and EMA regulations for biologic products.
• Approval Number: Refer to the regulatory body of the specific region (e.g., FDA BLA number for the U.S.).
• Date of Revision: As per the latest label update by the manufacturer.
• Manufacturer: Janssen Biotech, Inc.

Guidelines For The Use Of Siltuximab

• Dosage and Administration:
  Administer as an intravenous infusion at a recommended dose of 11 mg/kg every 3 weeks. Infuse over 1 hour; ensure the infusion rate is adjusted based on tolerance.
• Adverse Reactions:
  Common adverse reactions include fatigue, pruritus, rash, upper respiratory infections, and peripheral edema. Severe reactions such as infusion-related hypersensitivity and gastrointestinal disorders may occur.

Medication Limitations

• Contraindications:
  Patients with severe hypersensitivity to siltuximab or any excipients in the formulation.
• Precautions:
  • Monitor for infusion-related reactions during and after administration.
  • Not recommended for use in patients with severe infections or active tuberculosis.
  • Regularly assess liver function and blood cell counts due to potential hematological effects.

Siltuximab Interactions

Caution should be exercised when co-administering with other immunosuppressive agents, as the combination may increase the risk of infections. Interactions with CYP450-metabolized drugs should also be monitored, as IL-6 inhibition may alter their metabolism.

 

Note: If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYueMed(登越药业). It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.