Satralizumab-mwge Injection

WHY is this medicine prescribed?

Satralizumab-mwge injection is used to treat neuromyelitis optica spectrum disorder (NMOSD; an autoimmune disorder of the nervous system that affects eye nerves and the spinal cord) in certain adults. Satralizumab-mwge is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It works by blocking the activity of the part of the immune system that may damage certain areas of the nervous system in people with NMOSD.

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?

Satralizumab-mwge comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually injected once every 2 weeks for the first 3 doses and then once every 4 weeks as long as your doctor recommends that you receive treatment. Your doctor may decide that you or your caregiver can perform the injections at home. Your doctor will show you or the person who will be injecting the medication how to inject it. You or the person who will be injecting the medication should also read the written instructions for use that come with the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Remove the carton containing the medication from the refrigerator 30 minutes before your are ready to inject the medication. Check the carton to be sure that the expiration date printed on the package has not passed. Open the carton and remove the syringe. Look closely at the liquid in the syringe. The liquid should be clear and colorless to slightly yellow and should not be cloudy or discolored or contain particles. Call your pharmacist if there are any problems and do not inject the medication. Place the syringe on a flat surface and allow it to reach room temperature. Do not shake the syringe. Do not try to warm the medication by heating it in a microwave, placing it in warm water or in direct sunlight, or through any other method.

You may inject satralizumab-mwge injection on the front and middle of the thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. Do not inject the medication into skin that is tender, bruised, damaged, or scarred. Change (rotate) the injection site with each injection. Choose a different spot each time you inject the medication. Use the syringe within 5 minutes of removing the cap or the needle may clog.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with satralizumab-mwge 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 the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before using satralizumab-mwge injection,

• tell your doctor and pharmacist if you are allergic to satralizumab-mwge, any other medications, or any of the ingredients in satralizumab-mwge injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. 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 tuberculosis (TB; a serious lung infection) or hepatitis B (HBV; a virus that affects the liver). Your doctor will test you to see if you have TB or HBV before you begin your treatment. If you have TB or HBV, your doctor will probably tell you not to use satralizumab-mwge injection.

• tell your doctor if you have an infection or have had or have been in contact with someone with tuberculosis. Also, tell your doctor if you have liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using satralizumab-mwge, call your doctor.

• ask your doctor whether you should receive any vaccinations before you begin your treatment with satralizumab-mwge injection. Do not have any vaccinations before or during your treatment without talking to 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?

If you miss a dose of satralizumab-mwge, call your doctor about restarting your treatment schedule.

What SIDE EFFECTS can this medicine cause?

Satralizumab-mwge may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• joint or muscle pain
• pain in hands or feet
• depression
• headache

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

• fever, cough, diarrhea, runny nose, sore throat, chills, aches, burning when you urinate, urinating more often than usual or other signs of infection
• skin redness, swelling, tenderness, pain or sores
• rash or hives
• swelling of the face, lips, or tongue
• difficulty swallowing or breathing

Satralizumab-mwge 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 (http://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, out of reach of children, and away from light. Store prefilled syringes in the refrigerator; do not freeze. Unopened cartons containing the syringes can be removed and returned to the refrigerator, but should not be out of the refrigerator for a total time of greater than 8 days.

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. http://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 (http://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 and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to satralizumab-mwge.

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.