Glatiramer Acetate, Injection

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KEY POINTS

• This medicine is given by injection to reduce the number of attacks of relapsing-remitting multiple sclerosis. Use it exactly as directed. Do not stop these shots or change the dose or dose schedule unless you talk with your healthcare provider.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immunomodulator

Generic and brand names: glatiramer acetate, injection; Copaxone; Glatopa

What is this medicine used for?

This medicine is given by injection (shots) just under the skin to reduce the number of attacks of relapsing-remitting multiple sclerosis (RR MS). This medicine will not cure MS.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine or to mannitol (a sweetener).

Females of childbearing age: Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breast-feeding. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Your healthcare provider will give you the first shot. After that, you may be able to give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Do not stop these shots unless your healthcare provider tells you to stop. Do not change the dose or dose schedule without talking with your healthcare provider. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Your healthcare provider will want to check you regularly while you are receiving this medicine. Keep all appointments.

This medicine may cause chest pain that lasts a few minutes. This effect usually starts 1 month or longer after the start of treatment. You may have chest pain more than once during the treatment. Some side effects, including flushing of the face, fast or pounding heartbeat, anxiety, shortness of breath, trouble breathing, or hives may happen right after an injection and can last up to 15 minutes. These side effects can happen early in your treatment, or they can start several months after the start of treatment. They may go away as you continue with the treatment.

Tell your healthcare provider about any skin changes near the injection site. Talk with your healthcare provider about any side effects that continue or get worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; skin rash with irritation, dizziness, sweating, or severe pain at injection site; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Flushing, rapid or pounding heartbeat, anxiety, chest pain; skin discoloration or peeling at the injection site; signs of infection such as fever, chills, cough, or sore throat; swelling of the hands or feet.

Other: Nausea; vomiting; headache; weight gain; runny nose; redness, pain, swelling, or itching at the injection site; backache, weakness, nervousness.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the prefilled glass syringes in the refrigerator. Do not freeze them. You may keep the medicine at room temperature for up to 1 month. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.