How is Enspryng administered?

Enspryng is given as an injection under the skin (a subcutaneous injection) in the thigh or stomach area to treat neuromyelitis optica spectrum disorder (NMOSD) in adults. Your healthcare provider can teach you how to give these injections at home. After the first 3 doses given 2 weeks apart, you will administer one injection every 4 weeks thereafter.

Your healthcare professional will teach you or your caregiver how to inject Enspryng. You may also receive injections from your healthcare provider if you prefer. Do not inject the medicine until you have received proper training.

• The first 3 Enspryng injections are given once (1 time) every 2 weeks. After this, the injection is given once every 4 weeks (the maintenance phase).
• Keep using Enspryng once every 4 weeks for as long as your healthcare provider tells you to. Follow their instructions exactly.
• Review the Instructions for Use and diagrams found inside the carton for instructions on how to prepare and inject Enspryng. The medicine can be stored in your refrigerator.

Why is Enspryng given?

Enspryng (satralizumab-mwge) is approved by the FDA for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

What is neuromyelitis optica spectrum disorder (NMOSD)?

Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune disease of the central nervous system that leads to inflammation (swelling) in the nerves of the eye and the spinal cord. It occurs when the immune system attacks your own cells. It can occur after an infection or may be related to another autoimmune disease.

NMOSD can cause blindness, weakness in the arms or legs, painful spasms, numbness, uncontrollable vomiting and hiccups, and bladder or bowel trouble. Confusion, seizures, or comas can occur in children.

Tips for using Enspryng

Keep the unused syringe in the refrigerator between 36°F to 46°F (2°C to 8°C) until you are ready to use it. Do not freeze. Take the Enspryng carton out of the refrigerator about 30 minutes before injection time, this way it will warm up to room temperature and will be a more comfortable injection. Keep the carton and syringe away from sunlight, heat and any moisture.

If the Enspryng package has not been opened, it can be taken out of the refrigerator and put back, if needed, over time. Keep the syringe in its original package. 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).

The syringe has a needle-shield that automatically covers the needle when the injection is complete to help prevent accidental needle sticks. Do not replace the needle cover after removing it. You may also damage the needle.

Do not insert the syringe needle through your clothing, change the angle of the injection, or insert the needle again after injection.

Put your used syringe in an FDA-cleared sharps disposal container immediately after use. Do not throw away (dispose of) the syringe in your household trash.

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

Where do you inject Enspryng?

• Enspryng is given by a subcutaneous (under the skin) injection in the thigh or abdomen (stomach) area. You or a caregiver can learn to give these shots from a healthcare provider, or your doctor can give them to you.
• If you are self-administering Enspryng, change injection sites each time you give an injection.
• Do not inject into moles, scars, or areas that are tender, bruised, red, hard, or not intact.

How do you administer / inject Enspryng?

For more information on how to administer this medicine and see printed diagrams, review the “Instructions for Use” found in the Enspryng Patient Counseling information.

Before you inject this medicine for the first time, you should have received training from a healthcare professional.

• Step 1. To start, get your prefilled syringe carton out the fridge. Gather an alcohol wipe, a cotton ball or gauze pad, a small bandage, and an FDA-approved sharps disposal container.
• Step 2. Wash your hands with soap and water before you start. Clean the injection site with an alcohol wipe and let the areas dry. Do not blow on it.
• Step 3. Open the carton and carefully take out the syringe by holding the barrel. Do not shake the syringe. Do not use the medicine if it is expired, if the seal is broken on the package or if the solution inside the syringe looks cloudy, discolored, or contains particles. It is normal to see one or more bubbles in the syringe. If the syringe looks like it has been damaged, use a new one instead. Do not use it if the injection has been frozen.
• Step 4. You can inject into either the lower part of your stomach area (the abdomen) or the front and middle of your thighs. Do not inject into the 2-inch (5 cm) area around your belly button. Choose a different injection site for each new injection at least 1 inch (2.5 cm) away from the place where you last injected.
• Step 5. Remove the needle cap from the syringe and throw it away. Do not replace the needle cap as it may damage the syringe. You may see a drop of liquid at the end of the needle but this is normal. Use the syringe within 5 minutes of removing the cap or the needle may clog.
• Step 6. Hold the prefilled syringe in one hand. With the other hand gently pinch the skin at the chosen injection site to form a small raised area. Insert the needle at a 45-degree to 90-degree angle into the raised area, making sure you push the needle all the way in. Use a quick, dart-like motion to insert the needle.
• Step 7. After the needle is inserted, let go of the pinched skin. Slowly inject all of the medicine by gently pushing the plunger all the way down until it touches the activation guards.
• Step 8. Gently release the plunger and allow the needle to come out of the skin at the same angle it was inserted. The needle will now be covered by the needle-shield. If the needle is not covered, carefully place the syringe into an FDA-approved sharps container to avoid injury.
• Step 9. If there is bleeding at the injection site you can press a cotton ball or gauze over the area but do not rub it. Cover with a small band-aid if needed. If the medicine gets into contact with your skin, wash the area with water.
• Step 10. Throw away the used syringe into your sharps disposal container. Do not throw it away in your household trash.

This information does not take the place of talking to your healthcare provider about your medical condition, treatment or how to administer this medicine.

Bottom line

• Enspryng is given as a subcutaneous (under the skin) injection in adults for the treatment of neuromyelitis optica spectrum disorder (NMOSD), an autoimmune disorder that can affect the eyes and the spinal cord.
• Enspryng prefilled syringes can be self administered by the patient or a caregiver, or administered by your doctor. If you use it at home, your health provider should teach you how to inject yourself properly before your first use.
• The injections can be given into the top of the thighs or the abdomen area, but not in the two inches around the belly button. You should change (rotate) injection sites each time you give an injection.
• Follow the storage and administration instructions fully. Contact your doctor or pharmacist if you have any questions.

This is not all the information you need to know about Enspryng (satralizumab-mwge) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.