Uses

This medication is used to treat a certain nervous system disorder that affects the eye (optic) nerve and spinal cord (neuromyelitis optica spectrum disorder-NMOSD). Satralizumab belongs to a class of drugs known as monoclonal antibodies. It is not a cure for NMOSD but is thought to help by blocking interleukin-6, a substance made by the body. This effect may help to reduce the risk of attacks and delay or slow disability.

How To Use

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using satralizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before starting treatment with this medication, your doctor will test you for hepatitis B and tuberculosis (TB). If needed, treatment for hepatitis B, tuberculosis, or other infections should be done before receiving this medication.

This medication is given by injection under the skin of the abdomen or thigh as directed by your doctor. The first 3 doses are usually given 2 weeks apart. Later (maintenance) doses are usually given every 4 weeks.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.

Remove this medication from the refrigerator and leave it at room temperature for at least 30 minutes before use. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into moles, scars, or skin that is tender, bruised, red, hard, or damaged. Learn how to store and discard medical supplies safely.

The dosage and treatment schedule are based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days you need to inject the medication on a calendar.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Irritation, itching, or a lump at the injection site may occur. Joint/extremity pain, nausea, upset stomach, tiredness, or headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Satralizumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using satralizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• past/current/recent infection (especially of hepatitis B, tuberculosis)

Satralizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Your doctor may direct you to have any required vaccines at least 2 to 4 weeks before starting this medication. Tell your health care professional that you are using satralizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as complete blood count, liver function, tests for tuberculosis and hepatitis B) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original package in the refrigerator away from moisture and light. Do not freeze. The unopened package may be taken out of the refrigerator and put back in the refrigerator, if needed. The total time out of the refrigerator should not be more than 8 days. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).