Glatiramer acetate

Glatiramer acetate (brand name Copaxone, Glatopa, and generics) is used to treat relapsing forms of multiple sclerosis (MS) in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Glatiramer acetate's mechanism of action is not fully understood but it is thought to modify immune processes responsible for the development of MS and act locally rather than causing broad immune suppression. Glatiramer acetate injection contains a combination of the acetate salts of four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. These amino acids resemble the myelin protein surrounding nerve fibers and are thought to act as a decoy to divert an immune attack away from your myelin (see How does Copaxone work for multiple sclerosis?). Glatiramer acetate will not cure MS, but it can make relapses occur less often.

Glatiramer acetate belongs to the drug class immunomodulatory agents. It may also be called an immunostimulant.

Glatiramer acetate gained FDA approval on December 20, 1996, under the brand name Copaxone. Generic glatiramer acetate is available and manufacturers include Mylan, Synthon Pharms Inc., and Sandoz (under the name Glatopa).

Use glatiramer acetate injection exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Read and carefully follow any Instructions for Use provided with your medicine. Do not use glatiramer acetate if you don't understand all the instructions for proper use. Ask your doctor or pharmacist if you have questions.

Glatiramer acetate is injected under the skin (this is called subcutaneously).

Glatiramer acetate injections are given either daily or 3 times per week, depending on your dose.

Some glatiramer acetate products can be used with an optional compatible autoinjector. Compatible autoinjectors are supplied separately if available, but the availability of compatible autoinjectors may change with time.

Some people receiving a glatiramer acetate injection have had a severe reaction. Tell your caregiver right away if you feel anxious, warm, itchy, tingly, or have a pounding heartbeat, tightness in your throat, or trouble breathing during the injection. This type of reaction may occur even after you have been using this medicine for several months.

Call your doctor at once if you have:

Do not use glatiramer acetate if you are allergic to glatiramer acetate, Copaxone, Glatopa, or any inactive ingredients in the injection, including mannitol.

Tell your healthcare provider about all of your medical conditions, including if you:

Pregnancy

It is not known if glatiramer acetate will harm your unborn baby.

Breastfeeding

Clinically relevant levels of glatiramer acetate are not expected to pass into breast milk, but it is not known if glatiramer acetate affects breast milk production. Talk to your healthcare provider about the best way to feed your baby while using glatiramer acetate.

The most common side effects of glatiramer acetate are:

• skin problems at your injection site, such as redness, lumps, pain, itching, or swelling
• rash
• shortness of breath
• flushing (vasodilation)
• chest pain.

Serious side effects and warnings

Glatiramer acetate has a Boxed Warning for serious allergic reactions that may occur minutes or years after starting this medicine.

Serious allergic reactions (anaphylactic reactions). Serious allergic reactions that may be life-threatening or lead to death may happen any time after you start using glatiramer acetate. These reactions may happen right after your first dose up to years after starting treatment, even if you never had an allergic reaction before. Many reactions have happened within 1 hour of using glatiramer acetate. Some signs and symptoms may be the same as those of an immediate post-injection reaction. Stop using this medicine and get emergency help right away if you have:

• widespread rash
• swelling of the face, eyelids, lips, mouth, throat, or tongue
• sudden shortness of breath, difficulty breathing, or wheezing
• uncontrolled shaking (convulsions)
• trouble swallowing or speaking
• fainting, feeling dizzy or faint.

Immediate post-injection reactions. Serious side effects may happen right after or within minutes after you inject glatiramer acetate injection at any time during your course of treatment. Call your healthcare provider right away if you have any of these immediate post-injection reaction symptoms including:

If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a healthcare provider tells you to.

Chest Pain. You can have chest pain as part of an immediate post-glatiramer acetate injection reaction or by itself. This type of chest pain usually lasts a few minutes and can begin around 1 month after you start using glatiramer acetate. Call your healthcare provider right away if you have chest pain while using glatiramer acetate injection.

Damage to your skin. Damage to the fatty tissue just under your skin’s surface (lipoatrophy) and, rarely, death of your skin tissue (necrosis) can happen when you use glatiramer acetate. Damage to the fatty tissue under your skin can cause a “dent” at the injection site that may not go away. You can reduce your chance of developing these problems by:

Liver problems. Liver problems, including liver failure, can occur with glatiramer acetate. Call your healthcare provider right away if you have symptoms, such as:

It is not known if glatiramer acetate is safe and effective in children aged less than 18 years. Glatiramer acetate is not approved for use by anyone younger than 18 years old.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of glatiramer acetate. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose of Glatiramer Acetate for Multiple Sclerosis: glatiramer acetate 20 mg subcutaneously once a day or glatiramer acetate 40 mg subcutaneously 3 times a week.

Although glatiramer acetate starts working after your first injection, it may take 6 to 9 months to become fully effective and is considered a long-term treatment for MS (see How long can you take Copaxone?). In older patients, discontinuing glatiramer acetate does not appear to make any difference to MS relapse rates (see What happens if an MS patient stops taking Copaxone?).

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with glatiramer acetate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Store glatiramer acetate prefilled syringes in the refrigerator. Do not freeze. Throw away any syringe that has been frozen.

If refrigeration is not available, a glatiramer acetate prefilled syringe will keep for up to 30 days if stored at room temperature. Protect from moisture, light, and high heat.

Active ingredient: glatiramer acetate Inactive ingredient (Copaxone, Glatopa, generics): mannitol.

Available as:

• Glatiramer acetate 20 mg/mL in a single-dose prefilled syringe with a white plunger. • Glatiramer acetate 40 mg/mL in a single-dose, prefilled syringe with a blue plunger.

Teva Neuroscience, Inc., manufactures glatiramer acetate under the brand name Copaxone.

Sandoz manufactures glatiramer acetate under the generic name Glatopa.

Mylan and Synthon Pharms Inc., manufacture generic glatiramer acetate.