DrugindexOnline^{2nd edition}

Generic Name: Glatiramer (glah-TEER-ah-mer)
Brand Name: Copaxone

Glatiramer is used for:

Reducing the frequency of relapses with relapsing-remitting multiple sclerosis.

Glatiramer is a polypeptide mixture. How Glatiramer works is not fully understood. However, it is thought to act by changing immune processes responsible for the effects of multiple sclerosis.

Do NOT use Glatiramer if:

• you are allergic to any ingredient in Glatiramer or mannitol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Glatiramer :

Some medical conditions may interact with Glatiramer . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Glatiramer . However, no specific interactions with Glatiramer are known at this time.

Ask your health care provider if Glatiramer may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Glatiramer :

Use Glatiramer as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Glatiramer . Talk to your pharmacist if you have questions about this information.
• Glatiramer is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using this medicine at home, a health care provider will teach you how to use it. Be sure you understand how to use Glatiramer . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Glatiramer if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Glatiramer is only to be injected beneath the skin. Do not inject it into a vein.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• Glatiramer works best if it is given at the same time each day.
• If you miss a dose of Glatiramer , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Glatiramer .

Important safety information:

• Glatiramer may cause drowsiness, dizziness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Glatiramer with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Glatiramer should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Glatiramer while you are pregnant. It is not known if Glatiramer is found in breast milk. If you are or will be breast-feeding while you use Glatiramer , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Glatiramer :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety upon injection; back pain; chest tightness; diarrhea; ear pain; fever; flu symptoms or infection (fever, chills, sore throat); flushing; joint pain; loss of appetite; mild redness, pain, itching, or a lump at the injection site; nausea; neck pain; nervousness; pain; painful menstrual flow; rapid eye movement; skin nodules; stomach pain; sweating; swelling of the legs and feet; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain or tightness; continuing flushing and anxiety long after injection; dizziness; fast heartbeat; memory loss; pounding in the chest; severe pain, redness, or swelling at injection site; sweating; tightness in the throat; tremor.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Glatiramer :

Store Glatiramer in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted for up to 7 days. Protect from light. Keep Glatiramer out of the reach of children and away from pets.

General information:

• If you have any questions about Glatiramer , please talk with your doctor, pharmacist, or other health care provider.
• Glatiramer is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Glatiramer . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.