Glatiramer acetate

Glatiramer acetate is a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This drug seems to block myelin-damaging T-cells through a mechanism that is not completely understood. In controlled clinical trials with relapsing-remitting MS, those taking the glatiramer acetate had a significant reduction in annual relapse rate and a reduction in new lesions as shown on magnetic resonance imaging (MRI), when compared to control subjects who were given a placebo.

Approval by the U.S. Food and Drug Administration (FDA)

Glatiramer acetate is approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency of relapses in patients with relapsing-remitting MS. It is also approved for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with multiple sclerosis.
In January, 2014, the FDA approved a new 40 mg/mL dose of this medication, injected three times per week, which is double the standard 20 mg/mL dose that is injected daily. The approval was based on benefits and safety demonstrated in a one-year phase III trial comparing the higher, less-frequent dose of the medication with placebo. The standard dosing option continues to be available.

Proper Usage

• Glatiramer acetate is injected subcutaneously (between the fat layer just under the skin and the muscles beneath), either once a day (20 mg per mL dose) or three times per week (40 mg per mL dose). The 40 mg/mL doses should be taken at least 48 hours apart.
• The two dosages are not interchangeable. The 20 mg/mL syringe has a white plunger; the 40 mg/mL syringe has a blue plunger.
• The physician or nurse will instruct you in correct injection procedures, using a specially designed set of training materials. Do not attempt to inject yourself until you are sure that you understand the procedures.
• The pre-filled syringes of glatiramer acetate should be kept refrigerated. If refrigeration is not available, the drug may be safely stored at room temperature for up to one month. Allow the pre-filled syringe to stand at room temperature for 20 minutes before injecting.
• Glatiramer acetate is light-sensitive; protect it from light when not injecting.
• Use each pre-filled syringe for only one injection. Dispose of the syringes as directed by your physician and keep them out of the reach of children.
• Because injection-site reactions (swelling, redness, discoloration, or pain) are relatively common, it is recommended that the sites be rotated according to a schedule provided for you by your physician. Do not use any one site more than once per week.

Warnings and Precautions

• Do not use a pre-filled syringe that appears cloudy or contains particles.
• Do not change the dose or dosing schedule of this medication without consulting your physician.
• Glatiramer acetate is not recommended for use during pregnancy. Women who wish to become pregnant should discuss this medication, and all others they are taking, with their physician. If you become pregnant while on the medication, inform your physician. Glatiramer acetate is a Pregnancy Category B medication, meaning that although no adverse effects have been found in animal studies, no adequate, well-controlled studies have been done in pregnant women to demonstrate its safety in humans.
• It is not known whether glatiramer acetate passes into the breast milk. Nursing women should discuss the use of this medication with their physician.

Possible Side Effects

• Side effects that generally resolve on their own and do not require medical attention unless they continue for several weeks or are bothersome: injection-site reactions (e.g., swelling, the development of a hardened lump, redness, tenderness, increased warmth of the skin, itching at the site of the injection); runny nose; tremor*; unusual tiredness or weakness*; weight gain.
• Unusual side effects that should be discussed as soon as possible with your doctor:
  Hives (an itchy, blotchy swelling of the skin) or severe pain at the injection site.
• Possible immediate post-injection reaction: Approximately 13% of individuals using Copaxone will experience, at one time or another, a transient (very temporary) reaction immediately after injecting glatiramer acetate. This reaction, which usually occurs only once, includes flushing or chest tightness with heart palpitations, anxiety, and difficulty breathing. During the clinical trials, these reactions occurred very rarely, usually within minutes of an injection. They lasted approximately 15 minutes and resolved without further problem.

*Since it may be difficult to distinguish between certain common symptoms of MS and some side effects of glatiramer acetate, be sure to consult your health care professional if an abrupt change of this type occurs.