Glatiramer Acetate Solution for injection

What is this medicine?

GLATIRAMER (gla TIR a mer) helps to decrease the number of multiple sclerosis relapses in people with relapsing-remitting forms of the disease. The medicine does not cure multiple sclerosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• immune system problems
• infection
• an unusual or allergic reaction to glatiramer, mannitol, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• chest pain or tightness
• difficulty breathing
• fever, chills, or any other sign of infection
• rapid heartbeat or palpitations
• severe pain at the injection site
• swelling of the ankles

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• anxiety
• dizziness
• drowsiness
• flushing
• joint aches
• nausea, vomiting
• pain, redness, itching, or irritation at the injection site
• tremor
• weakness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). An unused prefilled syringe may be stored for up to 7 days between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Throw away any unused diluted injection. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.