ACTEMRA (Tocilizumab) – Rheumatoid Arthritis | HongKong DengYue Medicine

ACTEMRA Application Scope

Tocilizumab (Actemra®) is a humanized monoclonal antibody targeting IL-6 receptors. It is indicated for:

• Moderate to severe rheumatoid arthritis (RA) (alone or with MTX/DMARDs)

ACTEMRA Characteristics

• Ingredients: Tocilizumab – humanized anti-IL-6 receptor monoclonal antibody

• Properties:
  Solution for injection, colorless to slightly yellow, sterile, preservative-free.
• Packaging Specification:
  Glass vials:

  • 80 mg/4 mL: 1 vial/box or 4 vials/box

  • 200 mg/10 mL: 1 vial/box or 4 vials/box

  • 400 mg/20 mL: 1 vial/box or 4 vials/box

• Storage:
  Store at 2 °C–8 °C. Protect from light. Do not freeze.
• Expiry Date:
  36 months from the date of manufacture.
• Executive Standard:
  Imported Drug Registration Standard JS20220010
• Approval Number:

• 80 mg/4 mL: SJ20171024

• 200 mg/10 mL:  SJ20171025

• 400 mg/20 mL:  SJ20171026

• Date of Revision:
  2025-05-09
• Manufacturer:
  Chugai Pharma Manufacturing Co., Ltd.
  16-3 Kiyohara-Kogyodanchi, Utsunomiya-city, Tochigi, 321-3231, Japan

Guidelines for the Use of ACTEMRA

• Dosage and Administration:

  Recommended Dose:

  • SC: 162 mg once weekly (e.g., for RA)

  • IV: Typically every 4 weeks — dose varies per indication (Refer to label)

  • • Administration: Subcutaneous via syringe or autoinjector (ACTPen®), or IV infusion with proper dilution

    • Missed Dose: Administer as soon as possible; resume regular schedule

• Adverse Reactions:

  • Common Adverse Reactions (≥5%): Upper respiratory infections, headache, hypertension, elevated liver enzymes.

  • Serious Adverse Reactions: Serious infections (including TB), gastrointestinal perforation, demyelinating disorders, elevated liver enzymes.

  • Contraindications: Hypersensitivity to tocilizumab or excipients

  • Precautions: Avoid in active infection; monitor liver function, blood counts, and infection risk; avoid live vaccines; pregnancy/lactation – use only if benefit outweighs risk.

ACTEMRA Interactions

• May affect CYP450 substrates (e.g., warfarin, cyclosporine); monitor accordingly

 

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.