Satralizumab

Pronunciation: SAT-ra-LIZ-ue-max
Brand name: Enspryng
Dosage form: injection (120mg/mL)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 18, 2025.

What is satralizumab?

Satralizumab is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) a rare, chronic autoimmune disease that causes inflammation in the central nervous system. Satralizumab is used to reduce the risk of relapse in people who produce antibodies to a protein called aquaporin-4 (AQP4). Your doctor will test you for this antibody. This can lead to damage to the optic nerves, spinal cord, and/or brain.

Satrlizumab is given as a subcutaneous (under-the-skin) injection every 4 weeks for the maintenance treatment. These can be self-administered at home, offering a more convenient option for long-term disease management.

Satralizumab brand name is Enspryng made by Genentech, a member of the Roche Group.

Satralizumab mechanism of action is as an interleukin-6 (IL-6) receptor antagonist. it works by blocking the action of iIL-6 — a protein in the immune system that may play an important role in NMOSD. Satralizumab drug class is Interleukin inhibitors.

Satralizuma FDA approval was granted for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.  Satralizuma FDA approval was granted on August 14, 2020, based on positive results from clinical trials  SAkuraStar (NCT02073279) and SAkuraSky (NCT02028884) which demonstrated a significant reduction in the risk of relapse compared with placebo as a monotherapy, over 96 weeks. 

Satralizumab side effects

Common satralizumab side effects

Common satralizumab side effects from study 1 include:

• Rash (17%)
• Joint pain (17%)
• Pain in extremity (15%)
• Fatigue - tiredness (15%)
• Nausea (15%)
• Nasopharyngitis (12%)
• Itchy skin (10%)
• Depression (10%)
• Cellulitis (10%)
• Neutropenia -  lower levels of neutrophils in your blood (10%)
• Blood creatine phosphokinase increased (10%)
• Fall (10%)

Serious satralizumab side effects

Stop using satralizumab and get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; stomach pain, vomiting; difficulty 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.

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.

Related/similar drugs

Warnings

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 healthcare provider will check if you have an infection and treat it if needed before you start or continue to take this medicine

Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking satralizumab.

Before taking this medicine

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.

How should I use satralizumab?

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.

Satralizumab dosing information

Usual Adult Dose for Neuromyelitis Optica:

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

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

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking satralizumab?

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.

What other drugs will affect satralizumab?

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.

Storage

• Store ENSPRYNG in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton.
• Protect from light.
• Do not freeze or use the syringe if it has been frozen.
• Do not shake.
• ENSPRYNG, if unopened, can be removed from and returned to the refrigerator, if needed. The total combined time out of the refrigerator should not be more than 8 days at a temperature that does not go above 86°F (30°C).

Ingredients

Active ingredient: satralizumab-mwge

Inactive ingredients: L-arginine, L-histidine, poloxamer 188, L-aspartic acid, and Water for Injection.

Company

 Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 ENSPRYNG® is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan U.S. License No.: 1048 

Satralizumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for satralizumab.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer