Copaxone (Glatiramer Acetate) – Multiple Sclerosis | DengYue

Copaxone Application Scope

Copaxone (glatiramer acetate) is an injectable medication used to treat relapsing forms of multiple sclerosis.

Characteristics

• Ingredients: Glatiramer Acetate

• Properties: Immunomodulator mimicking myelin to reduce MS relapses

• Packaging Specification:

  • Supplied as prefilled syringes:

    • 20 mg/mL (white plunger)

    • 40 mg/mL (blue plunger)

• Storage:

  • Refrigerate at 2–8 °C

  • May be kept at room temperature (15–30 °C) up to 1 month

  • Do not freeze or expose to intense light

• Expiry Date: As printed on carton, based on stability studies;

• Executive Standard:

  • Meets FDA-approved prescribing information standards

  • Packaging aligns with USP and WHO GMP guidelines

• Approval Number:

  • U.S. initial approval 1996

  • Current FDA NDA updates (latest revision Jan 2025)

• Date of Revision: Full prescribing info revised January 2025

• Manufacturer: Teva Neuroscience, Inc., Parsippany, NJ

Guidelines for the Use of Copaxone

• Dosage and Administration:

  • 20 mg/mL: subcutaneous injection once daily

  • 40 mg/mL: subcutaneous injection three times per week, ≥48 hours apart

  • Warm to room temp ~20 minutes before injection, inspect for cloudiness or particles

  • Rotate injection sites (arms, thighs, abdomen, hips) and use cleaner techniques

• Adverse Reactions:

  • Common: injection‐site reactions, vasodilation/flushing, rash, dyspnea, chest pain

  • Others (≥1%): cough, pruritus, urticaria, lipoatrophy, hepatic injury

  • Serious:

    • anaphylaxis (life‑threatening, can occur at any time)

    • chest pain, skin necrosis, hepatic dysfunction

• Contraindications: Known hypersensitivity to glatiramer acetate or mannitol

• Precautions:

  • Monitor for immediate post-injection reactions

  • Monitor for chest pain; if hepatic dysfunction signs appear, consider discontinuation

  • Skin atrophy risk—rotate sites, inspect regularly

Copaxone Interactions

• Drug Interactions:

  • No major known interactions

  • But discuss all medications and supplements with your healthcare provider

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• 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.