Satralizumab (sat-ra-LIZ-ue-mab)

Treats neuromyelitis optic spectrum disorder (NMOSD).

Brand Name(s):

Enspryng

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the thighs or stomach.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, hard, or not intact, or areas with moles or scars.
• Remove the prefilled syringe from the refrigerator before using. Allow 30 minutes for the medicine to warm up to room temperature outside of the carton. Do not warm it in any other way.
• Check the liquid in the prefilled syringe. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake. Do not use the prefilled syringe if it has been damaged or broken.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep it in its original container. Do not use it if it has been frozen, even if it has been thawed. Protect from light. You may also store this medicine at room temperature for up to 8 days.
• Throw away used syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should have completed any needed vaccines at least 4 weeks for live or live-attenuated vaccines and at least 2 weeks for non-live (inactivated) vaccines before treatment with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or any type of infection.
• You will need to have a TB skin test before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick. You will be at risk for infections including hepatitis B infection reactivation or tuberculosis (TB) infection. Take precautions to prevent illness and injury.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dizziness or feeling faint

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint, arm, or leg pain
• Skin rash
• Sore throat, runny nose, cough
• Stomach upset
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088