"The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
MS is a chronic, inflammatory, autoimmune disease of the central nervous system"...
DOSAGE AND ADMINISTRATION
COPAXONE (glatiramer acetate) is for subcutaneous use only. Do not administer intravenously. The recommended dose of COPAXONE (glatiramer acetate) is 20 mg/day.
Instructions for Use
Remove one blister that contains the syringe from the COPAXONE (glatiramer acetate) prefilled syringes package. Since this product should be refrigerated, let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Inspect the COPAXONE (glatiramer acetate) syringe visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the COPAXONE (glatiramer acetate) syringe.
Areas for self-injection include arms, abdomen, hips, and thighs. The prefilled syringe is for single use only. Discard unused portions.
Dosage Forms And Strengths
Single-use prefilled syringe containing 1 mL solution with 20 mg of glatiramer acetate and 40 mg of mannitol.
COPAXONE (glatiramer acetate) is supplied as a single-use prefilled syringe containing 1 mL of a clear, colorless to slightly yellow, sterile, nonpyrogenic solution containing 20 mg of glatiramer acetate and 40 mg of mannitol in cartons of 30 single-use prefilled syringes with 33 alcohol preps (NDC 68546-317-30).
The recommended storage condition for the COPAXONE (glatiramer acetate) is refrigeration (2°C to 8°C /36°F to 46°F). However, excursions from recommended storage conditions (15°C to 30°C / 59°F 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 (glatiramer acetate) should not be frozen. If a COPAXONE (glatiramer acetate) syringe freezes, it should be discarded.
COPAXONE (glatiramer acetate) contains no preservative. Do not use if the solution contains any particulate matter.
Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131. Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454. Product of Israel.
Last reviewed on RxList: 4/15/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Copaxone Information
Copaxone - User Reviews
Copaxone User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.