Tofidence (Tocilizumab) Application Scope

An IL‑6 receptor antagonist for treating various autoimmune and inflammatory conditions, including arthritis types, vasculitis, lung disease, cytokine release syndrome, and severe COVID‑19.

Tocilizumab Characteristics

Ingredients:
Tocilizumab, a humanized monoclonal antibody targeting soluble and membrane-bound IL‑6 receptors
Properties:
Inhibits IL‑6 signaling to reduce inflammation and modulate immune response
Packaging Specification:
IV vials or SC prefilled syringe/autoinjector; packaged in cartons with safety caps
Storage: Refrigerate at 2–8 °C; do not freeze; protect from light; IV diluted solution stable up to manufacturer guidelines
Expiry Date: As labeled on the container (typically up to 30 months when refrigerated)
Executive Standard: Meets FDA, EMA, ICH Q6B, European Pharmacopoeia standards for monoclonal antibodies
Approval Number: FDA-approved 2010; EMA and others per local regulatory filings
Date of Revision: /
Manufacturer: Tofidence

Guidelines for the Use of Tocilizumab

Dosage and Administration:
- Recommended Dose: Varies by indication and route (IV or SC). For RA, typically 162 mg SC once weekly or IV infusion every 4 weeks.
- Administration:
  Administer via intravenous infusion or subcutaneous injection, depending on formulation.
- Missed Dose:
  If a dose is missed, administer as soon as possible. Resume schedule based on most recent dose timing.
Adverse Reactions:
- Common Adverse Reactions: Upper respiratory tract infections, headache, hypertension, increased liver enzymes.
- Serious Adverse Reactions: Serious infections, gastrointestinal perforation, anaphylaxis, demyelinating disorders, elevated liver enzymes.
Contraindications:

Patients with known hypersensitivity to Tocilizumab or any excipients.
Precautions:
- Infections: Do not administer during active infection. Monitor closely for signs of infection.
- Liver Function: Monitor ALT/AST levels regularly.
- Neutrophil and Platelet Count: Monitor during treatment.
- Live Vaccines: Avoid concurrent administration of live vaccines.
- Pregnancy and Lactation: Use only if potential benefit justifies the risk. Inform healthcare provider if pregnant or breastfeeding.

Tocilizumab Interactions

May interact with CYP450 substrates due to IL-6 inhibition. Monitor drugs with narrow therapeutic index (e.g., warfarin, cyclosporine).

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.