Enspryng 120 mg solucion inyectable en jeringa precargada

Prospect: information for the patient

Enspryng 120 mg injectable solution in pre-filled syringe

satralizumab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they do not appear in this prospect. See section 4.

In addition to this prospect, your doctor will also give you a patient information leaflet, which contains important safety information that you should know before and during treatment with Enspryng. Keep this leaflet with you at all times.

Instructions for use

What is Enspryng

Enspryng contains the active ingredient satralizumab. It is a type of protein called a monoclonal antibody. Monoclonal antibodies are designed to recognize a specific substance in the body and bind to it.

What is Enspryng used for

Enspryng is a medication used for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults and adolescents 12 years of age and older.

What is NMOSD

NMOSD refers to a central nervous system disease that primarily affects the optic nerves and spinal cord. It is caused by an incorrect functioning of the immune system (the body's defenses) that attacks the body's nerves.

• Damage to the optic nerves causes inflammation, which in turn causes pain and loss of vision.
• Damage to the spinal cord causes weakness or loss of mobility in the legs or arms, loss of sensation, and problems with bladder or intestinal function.

NMOSD flare-ups occur when there is inflammation in the nervous system. It also occurs when the disease recurs (recurs). Inflammation causes new symptoms or recurring previous symptoms.

How Enspryng works

Enspryng blocks the action of a protein called interleukin 6 (IL-6), which is involved in the process that leads to nerve damage and inflammation in the nervous system. By blocking its effects, Enspryng reduces the risk of recurrence or flare-up of NMOSD.

Do not use Enspryng:

• if you are allergic to satralizumab or any of the other ingredients of this medicine (listed in section 6).

If you are in any of the above situations or are unsure, do not use Enspryng and consult your doctor, pharmacist or nurse.

Warnings and precautions

Immediately contact your doctor if you experience any adverse reaction (see section 4. Possible side effects).

Consult your doctor, pharmacist or nurse before starting to use Enspryng if you are in any of the following situations (or if you are unsure).

Infections

You cannot use Enspryng while you have an infection.Inform your doctor or nurse immediately if you think you have any signs of infectionbefore, during or after treatment with Enspryng, such as:

• fever or chills
• persistent cough
• sore throat
• herpes labial or genital ulcers (herpes simplex)
• shingles (herpes zoster)
• redness, swelling, sensitivity or pain in the skin
• nausea or vomiting, diarrhea or stomach pain.

You will also find this information in the patient information leaflet that your doctor has provided to you. It is essential that you have this leaflet with you at all times and show it to any doctor, nurse or caregiver.

Your doctor will wait for the infection to be controlled before administering Enspryng to you or allowing you to continue with Enspryng injections.

Vaccines

Inform your doctor if you have recently received any vaccineor may receive one in the near future.

• Your doctor will check if you need any vaccine before starting treatment with Enspryng.
• You should not receive live or live attenuated vaccines (such as the BCG vaccine against tuberculosis or yellow fever vaccines) while on Enspryng treatment.

Liver enzymes

Enspryng may affect your liver and increase the levels of certain liver enzymes present in your blood. Your doctor will perform blood tests before starting Enspryng treatment and during it to check the proper functioning of your liver.Inform your doctor or nurse immediatelyif you experience any of the following signs of liver damage during or after Enspryng treatment:

• yellowing of the skin and the white part of the eyes (jaundice)
• dark-colored urine
• nausea and vomiting
• abdominal pain

White blood cell count

Your doctor will perform blood tests before starting Enspryng treatment and during it to review your white blood cell count.

Children and adolescents

This medicine should not be administered to children under 12 years old, as it has not yet been studied in this age group.

Other medicines and Enspryng

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medicine.

Inform your doctor or pharmacist if you are taking medicines such as warfarin, carbamazepine, phenytoin and theophylline, as the doses may need to be adjusted.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor may recommend that you stop breastfeeding if you need to receive Enspryng treatment. It is unknown whether Enspryng passes into breast milk.

Driving and operating machinery

It is unlikely that Enspryng will affect your ability to drive, ride a bike or use tools or machines.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount of Enspryng to be used

Each injection contains 120 mg of satralizumab. The first injection will be administered under the supervision of your doctor or nurse.

• The first three injections are administered once every 2 weeks. They are called "loading doses".
• From then on, the injection will be administered every 4 weeks. It is called "maintenance dose". You must continue with the injections once every 4 weeks for the time your doctor tells you.

How to use Enspryng

• Enspryng is administered by subcutaneous injection.
• In each injection, you must inject the complete content of the syringe.

At first, it is possible that your doctor or nurse will put the Enspryng injection for you. However, your doctor may decide that you can put the Enspryng injections yourself or that an adult caregiver can put them for you.

• You or your caregiver will receive training to learn how to put the Enspryng injections.
• Talk to your doctor or nurse if you or your caregiver have any questions about administering the injections.

Read carefully and follow the "Instructions for use" that appear at the end of this leaflet on how to inject Enspryng.

If you use more Enspryng than you should

Since Enspryng is contained in a pre-filled syringe, it is unlikely that you will receive an excessive amount. However, if you are concerned, consult your doctor, pharmacist, or nurse.

If you accidentally inject more doses than you should, you must contact your doctor. When you visit your doctor, always bring the outer packaging.

If you forgot to use Enspryng

It is very important not to miss any injections for the treatment to be fully effective.

If your doctor or nurse is administering the injections and you miss an appointment, you must schedule another one immediately.

If you are putting the Enspryng injections yourself and you miss one, put it as soon as possible. Do not wait until the next scheduled dose. After injecting the missed dose, you must put the next dose:

• if it is a loading dose: 2 weeks later
• if it is a maintenance dose: 4 weeks later

Consult your doctor, pharmacist, or nurse if you are unsure.

If you interrupt the treatment with Enspryng

Do not stop the treatment with Enspryng suddenly without consulting your doctor first. If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reaction

Inform your doctor immediately or go to the nearest hospital emergency department if you experience any signs of an allergic reaction during or after the injection. For example:

• Chest tightness or wheezing
• Sensation of difficulty breathing
• Fever or chills
• Intense dizziness or feeling of fainting
• Swelling of the lips, tongue, or face
• Itching, urticaria, or skin rash.

Do not take the next dose until you have spoken with your doctor and they tell you it is safe to do so.

Reactions related to the injection(very common: may affect more than 1 in 10 people)

Most cases are mild, although some can be severe.

Inform your doctor or nurse immediately if you experience any of the following signs during or after the injection, especially within the first 24 hours after the injection:

• Redness, itching, pain, or swelling at the injection site
• Skin rash, redness, or itching, or urticaria
• Headaches
• Irritation, swelling, or pain in the throat
• Sensation of difficulty breathing
• Low blood pressure (dizziness and feeling of fainting)
• Fever or chills
• Feeling tired
• Nausea, vomiting, or diarrhea
• Fast heart rate, rapid heartbeats, or increased pulse (palpitations).

Inform your doctor or nurse immediately if you experience any of the above symptoms.

Other side effects:

Very common(may affect more than 1 in 10 people):

• Headaches
• Joint pain
• High levels of lipids in the blood (fats)
• Low white blood cell count

Common(may affect up to 1 in 10 people):

• Sensation of stiffness
• Migraine
• Slow heart rate (bradycardia)
• Increased blood pressure
• Inability to fall asleep
• Swelling in the lower legs, feet, or hands
• Skin rash or itching
• Allergies or allergic rhinitis
• Stomach inflammation (gastritis), including stomach pain and nausea
• Weight gain
• Blood tests showing:

-Low levels of fibrinogen (a protein involved in blood clotting)

-High levels of liver enzymes (transaminases, possible sign of liver problems)

-High levels of bilirubin (possible sign of liver problems)

-Low platelet count (which may cause easy bleeding and bruising)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the pre-filled syringe label and on the box after “CAD”. The expiration date is the last day of the month indicated.
• Store in refrigerator (between 2 °C and 8 °C). Do not freeze. Do not use the syringe if it has frozen. Keep the syringe always dry.
• Store pre-filled syringes in the outer packaging to protect them from light and humidity.
• If stored in the outer packaging and unopened, Enspryng can remain outside the refrigerator below 30°C for a maximum period of 8 days. Do not re-store Enspryng in the refrigerator.
• Do not use and discard the pre-filled syringe if it has been outside the refrigerator for more than 8 days.

Do not use this medication if you observe that it is cloudy, has changed color, or contains particles. Enspryng is a colorless to slightly yellow liquid.

The medication must be injected immediately after removing the needle cap, and before 5 minutes to avoid the medication from drying and blocking the needle. If the pre-filled syringe is not used within 5 minutes after removing the needle cap, it must be discarded in a puncture-resistant container and a new one must be used.

Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

Composition of Enspryng

• The active ingredient is satralizumab. Each pre-filled syringe contains 120 mg of satralizumab in 1 ml.
• The other components are histidine, aspartic acid, arginine, poloxamer 188, and water for injection.

Appearance of the product and contents of the pack

• It is a colourless to slightly yellowish liquid.
• Enspryng is a solution for injection.
• Each pack of Enspryng contains 1 pre-filled syringe. Each multiple pack of Enspryng contains 3 pre-filled syringes (3 packs of 1). Some pack sizes may only be marketed.

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

There are also links to other websites on rare diseases and orphan medicines.

Instructions for use

Read these instructions for use:

• Before starting to use the pre-filled syringe
• Each time the prescribed medicine is dispensed, in case there is new information.

• This information does not replace a consultation with your doctor or nurse about your disease or treatment.
• Your doctor or nurse will decide whether you can administer the Enspryng injections yourself at home or whether it should be done by a caregiver. They will also show you or your caregiver how to use the syringe correctly and safely before you use it for the first time.
• If in doubt, consult your doctor or nurse.

Important information

• Each syringe is pre-filled with a medicine called Enspryng.
• Each pack of Enspryng contains only 1 pre-filled syringe.
• Each pre-filled syringe can only be used once.
• Do not share your syringes with others.
• Do not remove the needle cap until you are ready to administer the Enspryng injection.
• Do not use the syringe if it has fallen or is damaged.
• Do not attempt to disassemble the syringe at any time.
• Do not leave the syringe unattended.
• Do not re-use the same syringe.

Materials needed to administer the injection

Each pack of Enspryng contains:

• 1 pre-filled syringe for single use.

You will also need the following, as it is not included in the pack:

• 1 alcohol wipe
• 1 sterile cotton ball or gauze
• 1 bandage
• 1 puncture-proof container for safe disposal of the needle and syringe. See step 21 “How to dispose of Enspryng” at the end of these instructions for use.

Enspryng pre-filled syringe

(see figures A and B)

Before use:

Figure A

After use:

Figure B

The syringe has an automatic needle guard that covers the needle when the injection is finished.

Prepare for Enspryng administration

1. Take the pack containing the syringe out of the refrigerator and place it on a clean, flat surface (such as a table).
2. Check the expiration date on the back of the pack (see figure C).Do not use the syringe if the pack has expired.
3. Check that the front of the pack is properly sealed (see figure C).Do not use the syringe if the pack seal is broken.

If the expiration date has passed or the seal is broken, go to step 21 “How to dispose of Enspryng” and contact your doctor or nurse.

Figure C

1. Open the sealed pack(see figure D).

Figure D

1. Carefully remove the syringe from the pack by grasping the barrel(see figure E).

• Do not place the pack upside down to remove the syringe.
• Do not touch the activation protectors, as this may damage the syringe.
• Do not grasp the syringe by the plunger or the needle cap.

Figure E

Examine the syringe

(see figure F)

1. Check the expiration date of the syringe.Do not use the syringe if it has expired.
2. Inspect the syringe to check for any damage.Do not use the syringe if it is cracked or broken.
3. Through the view window, check that the liquid is transparent and colourless to slightly yellowish.

Do not administer the medicine if the liquid is cloudy, has changed colour, or contains particles.

• You may see small air bubbles in the syringe. This is normal and you should not attempt to remove them.

Figure F

If the expiration date has passed, the syringe is damaged, or the liquid is cloudy, has changed colour, or contains particles, do not use the medicine. Go to step 21 “How to dispose of Enspryng” and contact your doctor or nurse.

Let the syringe reach room temperature

1. Once you have examined the syringe, leave it on a clean, flat surface (such as a table) for30 minutesto allow it to reach room temperature(see figure G).

It is important to let the syringe reach room temperature slowly, as cold medicine may be uncomfortable and harder to push the plunger.

• Do not accelerate the warming process by heating the syringe in any way.
• Do not remove the needle cap while waiting for the syringe to reach room temperature.

Figure G

Wash your hands

10. Wash your hands with soap and water(see figure H).

Figure H

Choose the injection site

11. Choose an injection site from the following:

• the lower abdomen or
• the front and middle of the thighs(see figure I).

Figure I

• Do not inject in the 5 cm around the navel.
• Do not inject in moles, scars, haematomas, or areas where the skin is sensitive, red, hard, or damaged.

Choose a different injection site for each new injection. Choose a different site for each new injection, which is at least 2.5 cm away from the site used last time.

Clean the injection site

12. Clean the injection site with an alcohol wipe and let it dry.

• Do not fan or blow on the cleaned area.
• Do not touch the injection site again before administering the injection.

Figure J

How to administer Enspryng

13. Hold the syringe barrel with your thumb and index finger. With your other hand, pull the needle cap off. You may see a drop of liquid at the end of the needle, which is normal and will not affect the dose(see figure K).

• Use the syringe within 5 minutes of removing the needle cap; otherwise, the needle may become blocked.
• Do not remove the needle cap until you are ready to administer the Enspryng injection.
• Do not put the needle cap back on the needle once it has been removed, as this may damage the needle.
• Do not touch the needle or let it touch any surface after the needle cap has been removed.

Figure K

14. Immediately dispose of the needle cap in a puncture-proof container for safe disposal of needles. See step 21 “How to dispose of Enspryng”.

15. Hold the syringe barrel with your thumb and index finger. With your other hand, pinch the cleaned skin(see figure L).

16. With a quick movement, like throwing a dart, insert the needle into the skin at an angle of between 45° and 90°(see figure L).

• Do not change the angle of the injection while administering it.
• Do not insert the needle again.

Figure L

17. Once the needle is inserted, release the skin you were pinching.

18. Administer the medicine slowly by gently pushing the plunger down until it touches the activation protectors(see figure M).

Figure M

19. Carefully release the plunger and let the needle come out of the skin, keeping the same angle as when it was inserted(see figure N).

Figure N

• Next, the automatic needle guard will cover the needle. If the needle does not become covered, place the syringe in a puncture-proof container for safe disposal of needles to avoid injury. See step 21 “How to dispose of Enspryng”.

Care of the injection site

20. It is possible that there may be some bleeding at the injection site. You can press the injection site with a cotton ball or gauze until the bleeding stops, but do not rub. If necessary, you can also cover the injection site with a bandage. If the medicine comes into contact with the skin, wash the area with water.

How to dispose of Enspryng

21. Do not attempt to put the needle cap back on the syringe. Place the used syringe in a puncture-proof container for safe disposal of needles immediately after use(see figure O).Do not throw the syringe away in your home trash or recycle it.

Figure O

• Ask your doctor, nurse, or pharmacist where you can get a “needle” container or what other type of puncture-proof container you can use to safely dispose of used syringes and needle caps.
• Dispose of the puncture-proof container for safe disposal of needles as instructed by your doctor or pharmacist.
• Do not throw the puncture-proof container away in your home trash.
• Do not recycle the used puncture-proof container.