"The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).
Sandoz has received FDA approval to market "...
COPAXONE is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
DOSAGE AND ADMINISTRATION
COPAXONE is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:
- COPAXONE 20 mg per mL: administer once per day or
- COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart
COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.
Instructions For Use
Remove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration prior to administration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe.
Areas for subcutaneous self-injection include arms, abdomen, hips, and thighs. The prefilled syringe is for single use only. Discard unused portions.
Dosage Forms And Strengths
- Injection: 20 mg per mL in a single-dose, prefilled syringe with a white plunger. For subcutaneous use only.
- Injection: 40 mg per mL in a single-dose, prefilled syringe with a blue plunger. For subcutaneous use only.
Storage And Handling
COPAXONE (glatiramer acetate injection) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution supplied as:
- 20 mg per mL in a single-dose, prefilled syringe with a white plunger, in individual blister packages supplied in 30-count cartons (NDC 68546-317-30).
- 40 mg per mL in a single-dose, prefilled syringe with a blue plunger, in individual blister packages supplied in 12-count cartons (NDC 68546-325-12).
Store COPAXONE refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the patient may store COPAXONE at room temperature, 15°C to 30°C (59°F to 86°F), for up to one month, but refrigeration is preferred. Avoid exposure to higher temperatures or intense light. Do not freeze COPAXONE. If a COPAXONE syringe freezes, it should be discarded.
Marketed by: TEVA Neuroscience, Inc., Overland Park, KS 66211 Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454 Product of Israel. Revised: January 2014
Last reviewed on RxList: 2/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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