Glatiramer Acetate

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once daily or 3 times a week (at least 48 hours apart). The injection is given in the hip, thigh, abdomen, or back of the upper arm. The dosage is based on your medical condition and response to treatment.

Take the medication out of the refrigerator 20 minutes before you inject it to allow it to reach room temperature. Do not inject cold glatiramer because this can be painful. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Keep track of your injections and do not reuse the same injection site for at least 1 week. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. Do not change your dose or stop using this medication without talking with your doctor.

Tell your doctor if your condition gets worse.

See also Warning section.

Injection site reactions (such as pain, redness, soreness, and swelling) may occur. Nausea, chills, joint aches, neck pain, and headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Immediately after injection, you may experience flushing, chest pain, fast heartbeat, or anxiety. This post-injection reaction usually starts to occur after you have used the drug for a few months but can occur after any injection. These symptoms disappear fairly quickly and usually do not require treatment. If these symptoms do not go away in a few minutes, get medical help right away. Tell your doctor right away about this reaction before your next injection. Ask your doctor if you should keep using this medication.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: chest pain, signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of infection (such as sore throat that doesn't go away, fever), mental/mood changes (such as depression), severe pain at the injection site, shakiness (tremor), swelling of the legs/feet (water retention), vision problems.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Before using glatiramer, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as chest pain, heart attack), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Do not share this medication, needles, or syringes with others.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Store in the refrigerator. Do not freeze. Do not use this medication if it has been frozen. Keep the medication in the original carton to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, discard after 1 month. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.