Enspryng

Satralizumab.

It is a colourless to slightly yellow liquid.
The active substance is satralizumab. Each pre-filled syringe contains 120 mg of satralizumab in 1 mL.
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.
Excipients/Inactive Ingredients: The other ingredients are histidine, aspartic acid, arginine, poloxamer 188, water for injections.

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.
The damage to the optic nerves causes swelling, leading to pain and loss of sight.
The damage to the spinal cord causes weakness or loss of movement in the legs or arms, loss of feeling, and problems with bladder and bowel function.
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.

Enspryng is a medicine for treating neuromyelitis optica spectrum disorders (NMOSD) in adults and young people from 12 years of age.

This medicine should always be taken exactly as prescribed.
How much Enspryng to use: Each injection contains 120 mg of satralizumab. Patients must be advised that the first injection will be given under the supervision of the doctor or nurse.
The first three injections are given once every 2 weeks. These are called 'loading doses'.
After this, the injection is given every 4 weeks. This is called the 'maintenance dose'. The injections should be continued once every 4 weeks for as long as instructed/prescribed.
How to use Enspryng: Enspryng is given by injection under the skin (sub-cutaneously).
The entire content of the syringe should be injected each time.
At the start, Enspryng may be injected by a doctor or a nurse. However, it may be decided that the patient or an adult caregiver can inject Enspryng.
The patient or the caregiver must be advised regarding the training on how to inject Enspryng and questions about giving injections.
Read carefully and follow Instructions for use under Patient Counselling Information on how to inject Enspryng.
Forgotten administration of Enspryng: For the treatment to be fully effective, it is very important to keep having the injections.
If the doctor or nurse is giving the injections and the patient misses an appointment, the patient must be advised to make another one straight away.
If the patient is injecting Enspryng himself/herself and misses an injection, Enspryng should be injected as soon as possible. Advise the patient not to wait until the next planned dose. After having the injection for the missed dose, the next injection should be either: for loading doses - 2 weeks later; for maintenance doses - 4 weeks later.
Stopping administration of Enspryng: Enspryng should not be suddenly stopped unless advised/instructed.

Because Enspryng is in a pre-filled syringe, it is unlikely that the patient will receive too much.
Patients should seek medical attention if Enspryng is accidentally injected more than the prescribed dose.

Enspryng should not be administered to patients who are allergic to satralizumab or any of the other ingredients of this medicine (listed in Description).

Patients should seek medical attention immediately if the patient experiences any allergic reaction (see Side Effects).
Before taking Enspryng, caution should be exercised in case of taking, have recently taken or might take any other medicines such as warfarin, carbamazepine, phenytoin and theophylline as doses might need to be adjusted.
Infections: Enspryng cannot be used on patients with infection. Caution should be exercised in case of signs of infection before, during, or after Enspryng treatment such as: fever or chills; cough that does not go away; sore throat; cold sore or genital sores (herpes simplex); shingles (herpes zoster); skin redness, swelling, tenderness or pain; feeling or being sick, diarrhoea or belly pain.
This information can also be found in the patient alert card. Patients must be advised that the alert card should be kept at all times.
The infection should be controlled before giving the Enspryng or allowing the patient to continue to inject Enspryng.
Vaccinations: Before Enspryng administration, caution should be exercised in case of any vaccine given recently or might be given in the near future.
The need to administer any vaccines before starting Enspryng should be checked.
Live or live attenuated vaccines should not be administered (for example BCG for tuberculosis or vaccines against yellow fever) while being treated with Enspryng.
Liver enzymes: Enspryng can have effects on the liver and increase the amount of some liver enzymes in the blood. Blood tests should be done before the patient is given Enspryng, and during the treatment, to check how well the liver is working. Urgent medical advice or treatment may be needed in case of signs of liver damage during or after Enspryng treatment: yellowing of the skin and the whites of the eyes (jaundice); dark-coloured urine; feeling and being sick; abdominal pain.
White blood cell count: Blood tests should be performed before the patient is given Enspryng, and during the treatment, to check the patient's white blood cell count.
Driving and using machines: Enspryng is not likely to affect the ability to drive, cycle or use any tools or machines.
Use in Children: This medicine should not be given to children under 12 years of age. This is because it has not yet been studied in this age group.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Patients must be advised if the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby.
The patient may be advised to stop breast-feeding if Enspryng is to be given. It is not known whether Enspryng passes into breast milk.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions: Urgent medical advice or treatment may be needed in case of any signs of allergic reactions during or after the injection. They include: tight chest or wheezing; feeling short of breath; fever or chills; severe dizziness or light-headedness; swelling of the lips, tongue, face; skin itching, hives or rash.
The next dose should not be taken until instructed/advised.
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.
Urgent medical advice or treatment may be needed in case of any of these signs during or after the injection, particularly in the first 24 hours after the injection: redness, itching, pain or swelling where the injection is given; rash, red or itchy skin or hives; feeling flushed; headache; throat irritation, swelling or pain; feeling short of breath; low blood pressure (dizziness and light-headedness); fever or chills; feeling tired; feeling or being sick, or diarrhoea; fast heart rate, fluttering or pounding heart (palpitations).
Other side effects: Very common (may affect more than 1 in 10 people): headache; joint pain; high levels of blood lipids (fats); low level of white blood cells in tests.
Common (may affect up to 1 in 10 people): feeling stiff; migraine; slow heart beat (bradycardia); increase in blood pressure; being unable to sleep; swelling in the lower legs, feet or hands; rash or itching; allergies or hay fever; stomach inflammation (gastritis), including stomach pain and nausea; weight increase; blood tests showing: low fibrinogen levels (a protein involved in blood clotting), high level of liver enzymes (transaminases, possible sign of liver problems), high level of bilirubin (possible sign of liver problems), low level of platelets (which may lead to bleeding or bruising easily).

Do not throw away any medicines via wastewater or household waste. Patients must be advised on how to throw away medicines no longer used. These measures will help protect the environment.

Store in a refrigerator (2°C-8°C). Do not freeze. Do not use the syringe if it has been frozen. Always keep the syringe dry.
Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.
If unopened and kept in the outer carton, Enspryng may be left out of the refrigerator below 30°C for a single period up to 8 days. Do not return Enspryng to the refrigerator.
Do not use and discard the pre-filled syringe if it has been left out of the refrigerator for longer than 8 days.
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, it must be disposed in a puncture-resistant container and use a new pre-filled syringe.

Instructions for use: Read these instructions for use: Before you start using your pre-filled syringe; Each time you get a prescription refill, because it may contain new information.
This information does not take the place of talking to your doctor or nurse about your medical condition or treatment.
Your doctor or nurse will decide if you or a caregiver can give you injections of Enspryng at home. They will also show you or a caregiver the correct and safe way to use the syringe before you use it for the first time.
Talk to your doctor or nurse if you have any questions.
Important Information: Each syringe is pre-filled with a medicine called Enspryng.
Each carton of Enspryng contains only 1 pre-filled syringe.
Each pre-filled syringe can be used only once.
Do not share your syringes with other people.
Do not take the needle cap off until you are ready to inject Enspryng.
Do not use the syringe if it has been dropped or damaged.
Do not try to take the syringe apart at any time.
Do not leave the syringe unattended.
Do not re-use the same syringe.
Supplies needed to give your injection: Each Enspryng carton contains: 1 pre-filled syringe for one-time use only.
You also need the following but they are not included in the carton: 1 alcohol pad; 1 sterile cotton ball or gauze; 1 small bandage; 1 puncture-resistant sharps container for safe disposal of the needle cap and used syringe. See step 21 "Disposing of Enspryng" at the end of these instructions for use.
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. Do not use if the carton has expired.
3. Check that the front of the carton is sealed. 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" as follows and contact your doctor or nurse.
Check expiration date (back). Check if carton is sealed.
4. Open the sealed carton.
5. Carefully lift the syringe out of the carton by holding the barrel.
Do not turn the carton upside down to remove the syringe.
Do not touch the activation guards. This may damage the syringe.
Do not hold the plunger or needle cap.
Check the syringe: 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.
There may be some small air bubbles in the syringe. This is normal and you should not try to remove them.
Check expiration date. Check liquid. Check syringe for damage.
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" as follows 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.
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.
Do not speed up the warming process by heating the syringe in any way.
Do not remove the needle cover while the syringe is reaching room temperature.
Wash your hands: 10. Wash your hands with soap and water.
Choose the injection site: 11. Choose your injection site in either: the lower part of your stomach (abdomen) or, the front and middle of your thighs.
Do not inject into the 5 cm area around your belly button.
Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or broken.
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.
Do not fan or blow on the area which you have cleaned.
Do not touch the injection site again before you give the injection.
Inject Enspryng: 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.
Use the syringe within 5 minutes of removing the cap or the needle may clog.
Do not take the needle cap off until you are ready to inject Enspryng.
Do not put the needle cap back on once it has been removed as this may damage the needle.
Do not touch the needle or let it touch any surfaces after removing the needle cap.
14. Throw away the needle cap in a puncture-resistant sharps container immediately. See step 21 "Disposing of Enspryng" as follows.
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.
16. Use a quick, dart-like motion to insert the needle at an angle between 45° to 90°.
Do not change the angle of the injection while performing the injection.
Do not insert the needle again.
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.
19. 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 automatic needle-guard. If the needle is not covered, carefully place the syringe into a puncture-resistant sharps container to avoid injury. See step 21 "Disposing of Enspryng" as follows.
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. Do not throw the syringe in your household waste and do not recycle it.
Ask your doctor or nurse or pharmacist for information about where you can get a "sharps" container or what other types of puncture-resistant containers you can use to safely dispose of your used syringes and needle caps.
Dispose of the used sharps disposal container as instructed by your healthcare provider or pharmacist.
Do not dispose of your used sharps disposal container in your household waste.
Do not recycle your used sharps disposal container.

Immunosuppressants

L04AC19 - satralizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.

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