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

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

Glatiramer may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Glatiramer can be given using a prefilled syringe or an optional autoinjector. Use the medicine exactly as directed.

Glatiramer is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself. Do not inject into the same place two times in a row. Glatiramer 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 glatiramer if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

If you are using an autoinjector, make sure it is the right one. You can get the wrong dose if you use the incorrect autoinjector. Talk to your doctor or pharmacist if you have any 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.

Throw away a prefilled syringe after one use, even if there is still medicine left inside.

Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep 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 glatiramer if you are allergic to glatiramer or to mannitol.

Tell your doctor if you are pregnant or breastfeeding.

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: 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 glatiramer for several months.

Glatiramer may cause serious side effects. Call your doctor at once if you have:

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

• pain, burning, irritation, or skin changes where the injection was given; or

• symptoms of liver failure--diarrhea, loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes).

Common 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 affect glatiramer, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.