Copaxone (Glatiramer Acetate) - Indications and Dosage

INDICATIONS AND USAGE

COPAXONE^® Injection is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.

DOSAGE AND ADMINISTRATION

The recommended dose of COPAXONE^® Injection for the treatment of RR MS is 20 mg/day injected subcutaneously.

Instructions for Use

Remove one blister with the syringe inside from the COPAXONE^® Injection Pre-filled syringes package from the refrigerator. For refrigerated product, let the pre-filled syringe package stand at room temperature for 20 minutes to allow the solution to warm up to room temperature. Inspect the product visually and discard or return the product to the pharmacist before use if it contains any particulate matter.

Sites for self-injection include arms, abdomen, hips, and thighs. The pre-filled syringe is suitable for single use only; unused portions should be discarded. (See the COPAXONE^® Injection PATIENT INFORMATION  Leaflet for INSTRUCTIONS FOR INJECTING COPAXONE ^®.)

HOW SUPPLIED

COPAXONE^® Injection is supplied as a single-use pre-filled syringe containing 1.0 mL of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution containing 20 mg of glatiramer acetate and 40 mg of mannitol, USP in cartons of 30 single-use pre-filled syringes, 33 alcohol preps (wipes) and instructions for use.

The recommended storage condition for the COPAXONE^® Injection is refrigeration (2°C to 8°C / 36°F to 46°F). However, excursions from recommended storage conditions to room temperature conditions (15° to 30°C/ 59° to 86° F) for up to one month have been shown to have no adverse impact on the product. Exposure to higher temperatures or intense light should be avoided.

COPAXONE^® Injection contains no preservative. Do not use if the solution contains any particulate matter.

COPAXONE^® Injection is available in packs of 30 single-use Pre-Filled Syringes (NDC 0088-1153-30).

Rx only.