Uses

This medication is used to treat multiple sclerosis (MS). It is a protein that is thought to work by preventing your immune system from attacking the nerves in your brain and spinal cord. This effect can decrease the number of periods of disease worsening (relapses) and prevent or delay disability. It is not a cure for MS.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using glatiramer and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin as directed by your doctor. This medication is available in 2 different doses. Depending on your dose, it is usually given once daily or 3 times a week at least 48 hours apart. Follow your doctor's instructions carefully on how often you should use this medication. If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Your doctor will usually have you give your first injection in the office.

Wash and dry your hands before injecting glatiramer. Before using, warm the drug if it has been refrigerated by keeping the syringe at room temperature for 20 minutes. Do not inject cold glatiramer because this can be painful. This medication is normally clear and colorless to slightly yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the injection site daily to prevent problem areas under the skin. Keep track of your injections and do not reuse the same injection site for at least 1 week. Inject the medication under the skin of the hip, thigh, abdomen, or back of the upper arm. Do not inject into a vein. After pulling out the needle, apply gentle pressure on the injection site. Do not rub the area. Discard any unused portion in the syringe after a single use. Do not save for later use.

The dosage is based on your condition and response to treatment. 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.

Learn how to discard needles and medical supplies safely.

Tell your doctor if your condition worsens.

Side Effects

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, anxiety, shortness of breath, or itching. This 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 continue 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:

• dizziness/fainting
• 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

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

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 www.fda.gov/medwatch.

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

Precautions

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 breast-feeding.

Drug Interactions

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.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

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

Missed Dose

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 you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Refrigerate the syringes in their carton. Do not freeze. Do not use syringes that have been frozen. If refrigeration is not possible, the drug may be stored at room temperature for up to 1 month. Do not expose medication to light or high temperatures. 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.