Erenumab Application Scope

For prophylaxis of migraine in adult patients (preventive treatment of episodic migraine and chronic migraine according to local label).

Erenumab Characteristics

Ingredients:
- - Active ingredient: Erenumab (recombinant human monoclonal antibody, produced in CHO cells).
  - Excipients: Refer to local label for exact excipient list (stabilizers, buffers, etc.).
  Properties:Clear to slightly opalescent, colorless to pale-yellow sterile solution for injection. Supplied as single-use prefilled syringe or autoinjector.
Packaging Specification:
- 70 mg / 1 mL prefilled syringe / autoinjector (70 mg/mL).
- Some markets also supply 140 mg / 1 mL presentations (140 mg/mL) — check local packaging.
Storage:
- Refrigerate 2 °C – 8 °C (36 °F – 46 °F). Do not freeze. Protect from light. Keep in original carton until use.
- If removed from refrigeration, follow label guidance (some labels permit room-temperature storage up to a limited number of days — check local label).
Expiry Date: See vial/carton for expiry. Typical shelf life per product label is 36 months from manufacture (confirm on packaging).
Executive Standard: Manufactured and released according to applicable regulatory standards for therapeutic biological products (NMPA/ICH/GMP as applicable).
Approval Number: Manufactured and released according to applicable regulatory standards for therapeutic biological products (NMPA/ICH/GMP as applicable).
Date of Revision: China approval publicly announced Sept 21, 2023 (see local press/MAH announcement); check carton/label for the official revision date.
Manufacturer:
- Manufacturer (example on label): Amgen Manufacturing Limited (manufacturing).
- Marketing Authorization Holder (example for China import): Novartis Europharm Limited (local MAH/authorization may vary by market).

Guidelines for the Use of Erenumab

Dosage and Administration:
- Recommended Dose:
  - 70 mg subcutaneously once every 4 weeks, OR
  - 140 mg subcutaneously once every 4 weeks (as 2 × 70 mg or single 140 mg formulation) for patients requiring higher dose.
    (Use the dosing regimen specified in the local prescribing information.)
- Administration: For subcutaneous injection only. Administer with prefilled syringe or autoinjector. Can be administered by a healthcare professional or by a trained patient/caregiver following instruction.
- Missed Dose: If a dose is missed, administer as soon as possible and then resume the regular monthly dosing schedule. Do not double the dose to make up for a missed dose. Follow local label guidance.
Adverse Reactions:
- Common Adverse Reactions:
  - Injection site reactions (pain, erythema, swelling) — one of the most frequently reported events.
  - Constipation (reported at a higher frequency in some pooled data).
  - Upper respiratory tract infection, muscle spasms, pruritus, and other mild events.
- Serious Adverse Reactions:
  - Hypersensitivity reactions (including rare anaphylaxis) — monitor after administration.
  - Serious constipation with complications has been reported rarely; evaluate severe constipation promptly.
Contraindications: Known hypersensitivity to Erenumab or any excipient in the formulation.
Precautions:
- Observe patients for signs of hypersensitivity after injection.
- Use caution and clinical judgment in populations with limited data (pregnancy, lactation, pediatric <18 where not indicated, severe hepatic/renal impairment).
- Counsel patients about constipation risk and to seek care for severe or persistent constipation.

Erenumab Interactions

No clinically significant pharmacokinetic drug–drug interactions identified to date. Concomitant use with other monoclonal antibodies or immunomodulators should follow standard clinical judgment. Consult the full prescribing information for details.

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.