Satralizumab is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, chronic autoimmune disease that causes inflammation in the central nervous system. This can lead to damage of the optic nerves, spinal cord, and/or brain.

Satralizumab is used only if your body produces antibodies to a protein called aquaporin-4 (AQP4). Your doctor will test you for this antibody.

Satralizumab may also be used for purposes not listed in this medication guide.

Satralizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have signs of infection (fever, chills, cough, tiredness, muscle pain, diarrhea, stomach cramps, increased urination, burning when you urinate, skin sores or redness, swelling or tenderness).

Your doctor may perform tests to make sure you do not have conditions that would prevent you from safely using satralizumab.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Satralizumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not shake the prefilled syringe. Do not use if the syringe is damaged or if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Satralizumab is given in 3 loading doses once every 2 weeks, followed by maintenance doses given once every 4 weeks. Your doctor will determine how long to treat you with this medicine.

Inject all of the medicine in the prefilled syringe. Tell your doctor if you don't receive the full dose.

Your healthcare provider will show you where on your body to inject satralizumab. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You will need frequent medical tests.

Call your doctor if you have any signs of infection (fever, chills, cough, sore throat). Do not inject this medicine while you are having signs of an active infection.

If you stop using satralizumab for a short time, you may need to restart the medicine using loading doses once every 2 weeks. Follow your doctor's instructions very carefully.

Store in the refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not leave the medicine out of a refrigerator for longer than 8 days. Do not warm the medicine, and protect it from high heat.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Usual Adult Dose for Neuromyelitis Optica:

120 mg subcutaneously at Weeks 0, 2, and 4, followed by 120 mg subcutaneously every 4 weeks

Use: For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

You should not use satralizumab if you are allergic to it, or if you have an active infection such as:

• hepatitis B; or

• tuberculosis.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Tell your doctor if you have ever had:

• an active or chronic infection;

• liver problems, hepatitis B (or if you are a carrier of hepatitis B); or

• if you have recently received or are scheduled to receive a vaccine.

Make sure you are current on all vaccines before you begin treatment with satralizumab.

You should not receive a "live" vaccine for at least 4 weeks before using satralizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You should not receive a "non-live" (sometimes called inactivated) vaccine for at least 2 weeks before using satralizumab. Non-live vaccines include the flu (influenza) shot and injected vaccines for hepatitis A, polio, or rabies.

Tell your doctor if you are pregnant or breastfeeding.

If you use satralizumab while you are pregnant, make sure any doctor caring for your new baby knows that you used satralizumab during pregnancy. Being exposed to satralizumab in the womb could affect your baby's vaccination schedule.

Call your doctor for instructions if you miss a dose.

If you have stopped treatment for a side effect or infection, carefully follow your doctor's instructions about the schedule for restarting the medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not inject satralizumab into scars, moles, broken skin, or skin that is red, bruised, tender, or hard.

Do not receive any vaccine while using satralizumab.

Stop using satralizumab and get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; stomach pain, vomiting; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, night sweats;

• sore throat. ongoing cough, feeling very tired;

• muscle pain;

• diarrhea, stomach cramps;

• loss of appetite, weight loss;

• increased urination, burning when you urinate; or

• skin sores, redness, swelling or tenderness.

Common side effects of satralizumab may include:

• headache, joint pain;

• nausea, stomach pain;

• feeling tired;

• pain in your arms, hands, legs, or feet;

• rash; or

• cold symptoms such as stuffy nose, runny nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect satralizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.