Copaxone (Glatiramer Acetate)

(gla tir' a mer)

Glatiramer is used to reduce episodes of symptoms in patients with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Glatiramer is in a class of medications called immunomodulators. It works by stopping the body from damaging its own nerve cells (myelin).

Glatiramer comes as a solution to inject in the fatty layer just under the skin (subcutaneously). It is usually injected once a day. To help you remember to inject glatiramer, inject it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use glatiramer exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. You will receive your first dose of glatiramer in your doctor's office. After that, you can inject glatiramer yourself or have a friend or relative perform the injections. Before you use glatiramer yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. Glatiramer comes in prefilled syringes. Use each syringe only once and inject all the solution in the syringe. Even if there is still some solution left in the syringe after you inject, do not inject again. Dispose of used syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container. You can inject glatiramer into seven parts of your body: right and left arms, thighs, and hips; and lower stomach. There are specific spots on each of these body parts where you can inject glatiramer. Refer to the diagram in the manufacturer's patient information for the exact places you can inject. You should inject in each of the body parts once a week, and you should pick a different place on the body part each time. Keep a list of the places where you have given injections so that you will not inject in these places again until some time has passed. To inject glatiramer, follow these steps:

• Remove one blister pack from the carton of glatiramer syringes and place it on a clean flat surface. Wait 20 minutes to allow the medication to warm to room temperature.
• Wash your hands thoroughly with soap and water and dry them with a clean towel.
• Peel back the paper label and remove the syringe from the blister pack. Check your prefilled syringe to be sure it is safe to use. It should be labeled with the correct name of the medication and should contain a clear colorless solution. Do not use the syringe if it is expired, is cloudy, or contains any particles. Small air bubbles in the syringe will not cause any problems and you should not try to remove them.
• Wipe the place on your skin where you will inject glatiramer with a fresh alcohol pad and wait several seconds to allow it to dry.
• Pick up the syringe like a pencil and remove the needle cover.
• Use your other hand to pinch a 2-inch (5-centimeter) fold of skin between your thumb and index finger.
• Hold the syringe at a 90-degree angle to your body and push the needle straight into your skin. When the needle is all the way in, let go of the pinched fold of skin.
• Hold the syringe steady while slowly pushing down the plunger until the syringe is empty.
• Pull the needle straight out.
• Press a dry cotton ball on the injection site for a few minutes, but do not rub it.

Glatiramer controls multiple sclerosis but does not cure it. Continue to use glatiramer even if you feel well. Do not stop using glatiramer without talking to your doctor.

Before taking glatiramer,
• tell your doctor and pharmacist if you are allergic to glatiramer, mannitol, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using glatiramer, call your doctor.
• you should know that you may have a reaction immediately after you inject glatiramer. You may experience the following symptoms: flushing, chest pain, pounding heartbeat, anxiety, trouble breathing, closing of the throat, and hives. This reaction is most likely to occur several months into your treatment, but may happen at any time. These symptoms will usually go away without treatment in a short time. Get emergency medical care if these symptoms become severe or last longer than a few minutes. It is important to tell your doctor if this happens.

Unless your doctor tells you otherwise, continue your normal diet.

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

Glatiramer may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, redness, swelling, itching, or lump in the place where you injected glatiramer
• weakness
• flushing
• depression
• abnormal dreams
• pain in the back, neck, or any other part of the body
• severe headache
• loss of appetite
• diarrhea
• nausea
• vomiting
• weight gain
• swelling of the hands, feet, ankles, or lower legs
• purple patches on skin
• joint pain
• confusion
• nervousness
• crossed eyes
• difficulty speaking
• shaking hands that you cannot control
• sweating
• ear pain
• painful or changed menstrual periods
• vaginal itching and discharge
• urgent need to urinate or defecate
• tightness in muscles
• white patches in the mouth

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately. In some cases, your doctor may tell you to stop using glatiramer:

• dizziness
• excessive sweating
• chest pain
• sore throat, fever, chills, and other signs of infection
• runny nose
• coughing
• fast heartbeat
• fainting
• skin rash
• hives
• itching
• difficulty breathing or swallowing
• very severe pain at the injection site

Glatiramer affects your immune system, so it may increase your risk of developing cancer or a serious infection. Talk to your doctor about the risks of using this medication. Glatiramer may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in a refrigerator but do not freeze it. If you will not have access to a refrigerator, you can store glatiramer at room temperature for up to 7 days, but do not expose it to bright light. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.