Glatiramer Injection

(gla tir' a mer)

Brand Name(s): Copaxone^®, Glatopa^®; also available generically

Other Name(s): copolymer-1

IMPORTANT NOTICE:

FDA Medwatch Warning

• On January 22, 2025, the US Food and Drug Administration (FDA) issued a safety warning about the risk of a rare but serious allergic reaction called anaphylaxis with glatiramer. Anaphylaxis can occur at any time during treatment with glatiramer. In most cases, symptoms of anaphylaxis occurred one hour after an injection. In some cases, the anaphylaxis caused hospitalization and death.
• The following are symptoms of anaphylaxis: wheezing or difficulty breathing; swelling of the face, lips, or throat; hives; rash
• If you experience any of the symptoms of anaphylaxis, you should stop using glatiramer and call 911 or go to an emergency department right away. If you are told you have anaphylaxis from glatiramer, you should not use glatiramer again.
• Symptoms of anaphylaxis can be similar to an immediate post injection reaction that is temporary and usually goes away within 15-30 minutes. These symptoms include: flushing, chest pain, rash, palpitations (feeling of racing, fluttering or fast beating heart), anxiety, shortness of breath, rash or hives.
• If you experience symptoms of an injection reaction, you should call your prescriber right away. If the symptoms worsen or do not go away, you should call 911 or go to an emergency department. Do not take any more injections of glatiramer until told to do so.
• You can find more details regarding the FDA safety warning for glatiramer injection here: https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-called-anaphylaxis-multiple-sclerosis?utm_medium=email&utm_source=govdelivery

On May 16, 2024, the FDA issued a warning that some glatiramer products come with prefilled syringes while others can be used with an optional autoinjector. These cannot be used interchangeably. Doing so may result in an incorrect dose being given. If you are not sure if an autoinjector works with your specific glatiramer product, you are being encouraged to talk with your doctor or pharmacist.

WHY is this medicine prescribed?

Glatiramer injection is used to treat adults with various forms 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) including:

• clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours),
• relapsing-remitting forms (course of disease where symptoms flare up from time to time), or
• secondary progressive forms (course of disease where relapses occur more often).

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. 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: arms, thighs, 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. 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 near your navel (belly button) or waistline or into an area where the skin is sore, red, bruised, scarred, infected, or abnormal in any way.

You may experience a reaction immediately after you inject glatiramer such as flushing, chest pain, pounding heartbeat, anxiety, difficulty breathing, closing of the throat, or hives. This reaction is most likely to occur several months into your treatment, but could happen at any time during your treatment. These symptoms will usually go away without treatment in a short time. However, if these symptoms become severe or last longer than a few minutes, call your doctor and get emergency medical care.

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,

• tell your doctor and pharmacist if you are allergic to glatiramer, mannitol, or any other medications. Ask your pharmacist for a list of the ingredients.

• 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.

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 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
• weakness
• depression
• abnormal dreams
• pain in the back, neck, or other parts 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
• muscle tightness
• 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:

• dizziness
• excessive sweating
• sore throat, fever, runny nose, cough, chills, or other signs of infection
• fast heartbeat
• fainting
• rash
• itching
• difficulty swallowing

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.

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.

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. https://www.upandaway.org

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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2025.