This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00031/0916.
Enspryng 120 mg solution for injection in pre-filled syringe
Enspryng 120 mg solution for injection in pre-filled syringe
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
In addition to this leaflet, your doctor will also give you a patient alert card, which contains important safety information that you need to be aware of before and during treatment with Enspryng. Keep this alert card with you at all times.
1. What Enspryng is and what it is used for
2. What you need to know before you use Enspryng
3. How to use Enspryng
4. Possible side effects
5. How to store Enspryng
6. Contents of the pack and other information
Instructions for use
Enspryng contains the active substance satralizumab. It is a type of protein called a monoclonal antibody. Monoclonal antibodies are designed to recognise and attach to a specific substance in the body.
Enspryng is a medicine for treating neuromyelitis optica spectrum disorders (NMOSD) in adults and young people from 12 years of age.
NMOSD is a disease of the central nervous system that mainly affects the optic nerves and spinal cord. It is caused by the immune system (the body’s defences) working incorrectly and attacking nerves in the body.
In an attack of NMOSD, there is swelling in the nervous system. This also happens when the disease comes back (relapse). The swelling causes new symptoms or a return of previous symptoms.
Enspryng blocks the action of a protein called interleukin-6 (IL-6), which is involved in the processes that lead to damage and swelling in the nervous system. By blocking its effects, Enspryng reduces the risk of a relapse or attack of NMOSD.
If the above applies to you or you are not sure, do not use Enspryng and talk to your doctor, pharmacist or nurse.
Talk to your doctor immediately if you experience any allergic reaction (see section 4. Possible side effects).
Talk to your doctor, pharmacist or nurse before using Enspryng if any of the below apply to you (or if you are not sure).
You cannot use Enspryng while you have an infection. Tell your doctor or nurse straight away if you think you have any signs of infection before, during, or after Enspryng treatment such as:
You will also find this information in the patient alert card you have been given by your doctor. It is important that you keep this alert card with you at all times and show it to any doctor, nurse or caregiver.
Your doctor will wait until the infection is controlled before giving you Enspryng or allowing you to continue to inject Enspryng.
Tell your doctor if you have recently been given any vaccine or might be given a vaccine in the near future.
Enspryng can have effects on your liver and increase the amount of some liver enzymes in your blood. Your doctor will do blood tests before you are given Enspryng, and during your treatment, to check how well your liver is working. Tell your doctor or nurse straight away if you have any of these signs of liver damage during or after Enspryng treatment:
White blood cell count
Your doctor will perform blood tests before you are given Enspryng, and during your treatment, to check your white blood cell count.
Do not give this medicine to children under 12 years of age. This is because it has not yet been studied in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist if you are taking medicines such as warfarin, carbamazepine, phenytoin and theophylline as doses might need to be adjusted.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor may advise you to stop breast-feeding if you are to be given Enspryng. It is not known whether Enspryng passes into breast milk.
Enspryng is not likely to affect you being able to drive, cycle or use any tools or machines.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Each injection contains 120 mg of satralizumab. The first injection will be given under the supervision of your doctor or nurse.
At the start, your doctor or nurse may inject Enspryng. However, your doctor may decide that you or an adult caregiver can inject Enspryng.
Read carefully and follow the “Instructions for use” at the end of this leaflet on how to inject Enspryng.
Because Enspryng is in a pre-filled syringe, it is unlikely that you will receive too much. However, if you are worried, talk to your doctor, pharmacist or nurse.
If you accidentally inject more doses than you should, call your doctor. Always take the outer carton with you when you go to see the doctor.
For the treatment to be fully effective, it is very important to keep having the injections.
If your doctor or nurse is giving your injections and you miss an appointment, make another one straight away.
If you are injecting Enspryng yourself and you miss an injection, inject it as soon as possible. Do not wait until the next planned dose. After you have had the injection for the missed dose, your next injection should be either:
Check with your doctor, pharmacist or nurse if you are not sure.
Do not suddenly stop using Enspryng without asking your doctor first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away or go to the emergency department of your nearest hospital, if you have any signs of allergic reactions during or after the injection. They include:
Do not take the next dose until you have spoken with your doctor and your doctor has told you to take the next dose.
Injection-related reactions (very common: may affect more than 1 in 10 people)
In most cases these are mild reactions, but some can be serious.
Tell your doctor or nurse straight away if you have any of these signs during or after the injection, particularly in the first 24 hours after the injection:
Tell your doctor or nurse straight away if you have any of the signs above.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Do not use this medicine if it is cloudy, discoloured or contains particles. Enspryng is a colourless to slightly yellow liquid.
The medicine must be injected right after removing the cap and no later than 5 minutes to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of removing the cap, you must dispose of it in a puncture-resistant container and use a new pre-filled syringe.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
This leaflet was last revised in June 2023
Supplies needed to give your injection
Each Enspryng carton contains:
You also need the following but they are not included in the carton:
Enspryng pre-filled syringe
(See Figure A and Figure B)
The syringe has an automatic needle-guard that covers the needle when the injection is complete.
Prepare to use Enspryng
1. Take the carton containing the syringe out of the refrigerator and place it on a clean, flat work surface (like a table).
2. Check the expiry date on the back of the carton (see Figure C). Do not use if the carton has expired.
3. Check that the front of the carton is sealed (see Figure C). Do not use if the seal is broken.
If the expiry date has passed or the seal is broken, go to step 21 “Disposing of Enspryng” and contact your doctor or nurse.
4. Open the sealed carton (see Figure D).
5. Carefully lift the syringe out of the carton by holding the barrel (see Figure E).
Check the syringe
(See Figure F)
6. Check the expiry date on the syringe. Do not use the syringe if it has expired.
7. Check the syringe for any damage. Do not use if it is cracked or broken.
8. Check that the liquid through the viewing window is clear and colourless to slightly yellow. Do not inject the medicine if the liquid is cloudy, discoloured, or has particles in it.
If the expiry date has passed, the syringe is damaged or the liquid is cloudy, discoloured or has particles in it, do not use. Then go to step 21 “Disposing of Enspryng” and contact your doctor or nurse.
Let your syringe get to room temperature
9. Once you have checked the syringe, place it on a clean, flat work surface (like a table) for 30 minutes. This will allow it to reach room temperature (see Figure G).
It is important to let the syringe gently reach room temperature because injecting cold medicine may feel uncomfortable and make it harder to push the plunger.
Wash your hands
10. Wash your hands with soap and water (see Figure H).
Choose the injection site
11. Choose your injection site in either:
Choose a different injection site for each new injection. Choose a different site for each new injection at least 2.5 cm away from the place used last time.
Clean the injection site
12. Wipe the injection site with an alcohol pad and let it air dry.
13. Hold the barrel of the syringe between your thumb and index finger. With your other hand, pull the needle cap straight off. You may see a drop of liquid at the end of the needle. This is normal and will not affect your dose (see Figure K).
14. Throw away the needle cap in a puncture-resistant sharps container immediately. See step 21 “Disposing of Enspryng”.
15. Hold the barrel of the syringe using your thumb and index finger. With your other hand, pinch the area of skin you have cleaned (see Figure L).
16. Use a quick, dart-like motion to insert the needle at an angle between 45° to 90° (see Figure L).
17. After the needle is inserted, let go of the pinched skin.
18. Slowly inject all of the medicine by gently pushing the plunger all the way down until it touches the activation guards (see Figure M).
19. Gently release the plunger and allow the needle to come out of the skin at the same angle it was inserted (see Figure N).
Taking care of the injection site
20. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site until any bleeding stops but do not rub it. If needed, you may also cover the area you injected with a small bandage. If the medicine comes into contact with your skin, wash the area with water.
Disposing of Enspryng
21. Do not try to re-cap your syringe. Put your used syringe in a sharps disposal container immediately after use (see Figure O). Do not throw the syringe in your household waste and do not recycle it.