Copaxone is a combination of four amino acids (proteins) that affect the immune system.

Copaxone injection is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Copaxone will not cure MS, but it can make relapses occur less often.

Use Copaxone 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. Follow the instructions on your prescription label.

Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Copaxone is given as an injection under your skin. You may be given instructions on how to inject your medicine at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

Some people receiving a Copaxone 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 month

Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Copaxone if you are allergic to glatiramer or to mannitol.

Tell your doctor if you are pregnant or breastfeeding.

Copaxone is not approved for use by anyone younger than 18 years old.

Use Copaxone injection exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Copaxone is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself. Copaxone injections are given either daily or 3 times per week, depending on your dose.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Copaxone if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

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

Take the medicine out of the refrigerator and let it reach room temperature for 20 minutes before injecting your dose.

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

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Multiple Sclerosis:

20 mg subcutaneously once a day or 40 mg subcutaneously 3 times a week

Comments:
-For the 3 times a week dosage regimen, each dose must be separated by at least 48 hours.
-Length of treatment should be individualized.

Approved indication: For the treatment of patients with relapsing forms of multiple sclerosis

You should not use Copaxone if you are allergic to glatiramer or to mannitol.

Tell your doctor if you are pregnant or breastfeeding.

Copaxone is not approved for use by anyone younger than 18 years old.

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.

Get emergency medical help if you have signs of an allergic reaction to Copaxone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur within minutes after an injection. Tell your doctor if you have any of these symptoms: itching, rash, swelling, warmth, skin redness, tingling, anxiety, fast or pounding heartbeats, chest pain, tightness in your throat, or trouble breathing.

This type of reaction may occur even after you have been using Copaxone for several months.

Call your doctor at once if you have:

• chest pain (may occur alone or with other side effects shortly after an injection); or

• hollowing or other skin changes where the injection was given.

Common Copaxone side effects include:

• feeling short of breath;

• flushing (sudden warmth, redness, or tingly feeling);

• rash; or

• redness, pain, itching, swelling, or a lump where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with glatiramer, 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.