Glatiramer Injection

IMPORTANT WARNING:

Glatiramer injection may cause serious or life-threatening allergic reactions. These reactions may happen within minutes after your injection or at any time during your treatment. If you experience any of the following symptoms at any time during your treatment, call your doctor immediately or get emergency medical care: rash; hives; itching; flushing; difficulty swallowing, speaking, or breathing; shortness of breath; wheezing; hoarseness; swelling of the face, throat, tongue or lips; fainting; dizziness; chest pain or discomfort; fast heartbeat; feeling anxious; or uncontrollable shaking.

You will be given the Medication Guide when you begin treatment with glatiramer injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

WHY is this medicine prescribed?

Glatiramer injection is used to treat various forms of multiple sclerosis (MS; a disease that damages nerves and can cause weakness, numbness, trouble walking or talking, vision changes, and other problems).

Glatiramer is in a class of medications called immunomodulators. It works by stopping the body from damaging its own nerve cells (myelin).

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Glatiramer comes as a solution to inject subcutaneously (under the skin). Depending on your dose, it is usually injected either once a day or three days every week (with at least 48 hours between doses, for example every Monday, Wednesday, Friday). To help you remember to inject glatiramer, inject it around the same time every day.

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 give the injections. Before you use glatiramer yourself the first time, read the written instructions that come with 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.

Your doctor or pharmacist may tell you that you can use an automatic injection device to inject glatiramer. Talk to your doctor or pharmacist about which device can be used with your medication.

You can inject glatiramer anywhere on the front of your thighs, back of your arms, upper hips, and lower stomach area except your belly button and the area 2 inches (5 centimeters) around it. Choose a different spot each time you inject your medication. Keep a record of the date and spot of each injection. Do not use the same spot two times in a row. Do not inject into an area where the skin is sore, red, bruised, scarred, infected, or abnormal in any way.

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.

What SPECIAL PRECAUTIONS should I follow?

Before using glatiramer injection,

• tell your doctor and pharmacist if you are allergic to this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• 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 liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using glatiramer injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

Glatiramer injection 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 at the injection site
• abnormal dreams
• back pain
• vomiting
• weight gain
• swelling of the hands, feet, ankles, or lower legs
• sweating
• vaginal itching and discharge
• eye or vision problems
• white patches in the mouth

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• sore throat, fever, runny nose, cough, chills, or other signs of infection
• nausea, loss of appetite, tiredness or sleepiness, pain in the upper right part of the stomach, bruising or bleeding, yellowing of the skin or eyes, confusion, dark urine, or pale stools

Glatiramer may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of 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 1 month, but do not expose it to bright light or higher temperatures.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.