Glatiramer Acetate (gla-TIR-a-mer AS-e-tate)

Treats relapsing-forms of multiple sclerosis (MS).

Brand Name(s):

Copaxone, Glatopa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that have scars or dents. Do not inject this medicine into your veins.
• This medicine comes in a prefilled syringe. It may also be given using an autoinjector that is compatible with glatiramer. Do not use an autoinjector that is not meant to be used with this medicine.
• Check the liquid in the prefilled syringe. It should be colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.
• Allow the prefilled syringe to warm to room temperature for 20 minutes before using it.
• Use a new needle and syringe each time you inject your medicine.
• Do not stop using this medicine without first checking with your doctor.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may also store this medicine at room temperature for up to 1 month. Avoid exposing this medicine to higher temperatures or bright or intense light.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how glatiramer works. Tell your doctor if you are using interferon beta.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or any type of infection.
• This medicine may cause the following problems:
  • Chest pain
  • Serious skin problems
  • Liver problems, including liver failure or hepatitis with jaundice
• Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.
• Avoid people who are sick or have infections.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, fast, pounding, or uneven heartbeat, trouble swallowing, warmth or redness in your face, neck, arms, or upper chest
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Severe pain, redness, swelling, itching, peeling, or lump where the shot is given
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Unusual bleeding, bruising, or tiredness

If you notice these less serious side effects, talk with your doctor:

• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088