Enspryng

Package leaflet: Information for the patient

Enspryng 120 mg solution for injection in pre-filled syringe

satralizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

In addition to this package leaflet, your doctor will also provide you with a patient alert card containing important safety information you should be aware of before and during treatment with Enspryng. Always carry the patient alert card with you.
Contents of this leaflet

1. What Enspryng is and what it is used for
2. What you need to know before using 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

1. What Enspryng is and what it is used for

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

What Enspryng is used for
Enspryng is a medicine used to treat neuromyelitis optica spectrum disorders (NMOSD) in adults and children from the age of 12 years.

What is NMOSD?
NMOSD is a disease of the central nervous system that mainly affects the optic nerves and the spinal cord. It is caused by a malfunction of the immune system (the body's defences), which attacks the nerves of the affected person.

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

When an NMOSD "attack" occurs, it causes inflammation in the nervous system. The same happens when the disease reappears (relapse). This inflammation leads to the appearance of new symptoms or the return of previous symptoms.

How Enspryng works
Enspryng blocks the action of a protein called "interleukin-6" (IL-6), which is involved in the processes that cause damage and inflammation in the nervous system. By blocking the effects of this protein, Enspryng reduces the risk of relapse or an NMOSD attack.

2. What you should know before using Enspryng

Do not use Enspryng

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

If the condition described above applies to you or if you have any doubts, do not use Enspryng and speak with your doctor,
pharmacist, or nurse.
Warnings and precautions
If you experience any allergic reaction, contact your doctor immediately (see section 4 “Possible side effects”).
Before using Enspryng, if you have any of the following conditions (or if you have any doubts), speak with your
doctor, pharmacist, or nurse.
Infections
You must not use Enspryng while you have an active infection. Inform your doctor or nurse immediately if
you think you have signs of an infection before, during, or after treatment with Enspryng, such as:

• fever or chills
• persistent cough
• sore throat
• cold sores or genital herpes (herpes simplex)
• shingles (herpes zoster)
• redness, swelling, tenderness, or pain of the skin
• feeling unwell, vomiting, diarrhoea, or stomach pain.

You will also find this information in the patient alert card provided to you by your doctor. It is important that you
always carry this alert card with you and show it to any doctor, nurse, or caregiver.
Before administering Enspryng or allowing you to continue Enspryng injections, your doctor will wait until the
infection is under control.
Vaccinations
Inform your doctor if you have recently received any vaccine or might receive a vaccine in the near future.

• Your doctor will check whether you need to receive vaccines before starting treatment with Enspryng.
• Do not receive vaccinations with live or live-attenuated vaccines (for example, the BCG vaccine against tuberculosis or vaccines against yellow fever) while you are receiving treatment with Enspryng.

Liver enzymes (hepatic)
Enspryng may affect the liver and increase the levels of certain liver enzymes in the blood. Before administering
Enspryng and during treatment, your doctor will perform a blood test to monitor how well your liver is functioning.
Inform your doctor or nurse immediately if you notice any of the following signs of liver damage during or after
treatment with Enspryng:

• yellowing of the skin or the whites of the eyes (jaundice)
• dark urine
• feeling unwell
• abdominal pain.

White blood cell count
Before administering Enspryng and during treatment, your doctor will perform blood tests to monitor your
white blood cell count.
Children and adolescents
Do not give this medicine to children under 12 years of age, as it has not been studied in this age group.
Other medicines and Enspryng
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking medicines such as warfarin, carbamazepine,
phenytoin, or theophylline, as dose adjustments may be necessary.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
Your doctor may advise you to stop breastfeeding if you are to receive Enspryng. It is not known whether Enspryng
passes into breast milk.
Driving and using machines
It is unlikely that Enspryng will affect your ability to drive vehicles, ride a bicycle, or operate any tools or machinery.

3. How to use Enspryng

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Enspryng to use
Each injection contains 120 mg of satralizumab. The first injection will be administered under
the supervision of a doctor or nurse.

• The first three injections are given every 2 weeks and are called the “loading doses”.
• After that, the injection should be administered every 4 weeks. This is known as the “maintenance dose”. Continue receiving injections every 4 weeks for as long as your doctor directs.

How to use Enspryng

• Enspryng is administered by subcutaneous injection (“subcutaneous route”).
• Each time, inject the entire contents of the syringe.

Initially, your doctor or nurse may administer Enspryng to you. However, your doctor may decide that you, or an adult caregiver assisting you, can administer the Enspryng injection.

• You or your caregiver will receive detailed instructions on how to inject Enspryng.
• Inform your doctor or nurse if you or your caregiver have any questions about how to give the injections.

Read carefully and follow the instructions for injecting Enspryng provided in the “Instructions for use” at the end of this leaflet.
If you use more Enspryng than you should
Since Enspryng comes in a pre-filled syringe, it is unlikely that you will receive too much. However, if you have any concerns, contact your doctor, pharmacist, or nurse.
If you accidentally inject more than the prescribed dose, contact your doctor. Always bring the package with you when visiting your doctor.
If you forget to use Enspryng
To ensure the treatment remains fully effective, it is very important to continue your injections as scheduled.
If your doctor or nurse administers the injections and you miss an appointment, schedule another one immediately.
If you self-administer Enspryng injections and miss a dose, administer it as soon as possible. Do not wait until your next scheduled dose. After administering the missed dose, the next injection should be given as follows:

• for loading doses – after 2 weeks
• for maintenance doses – after 4 weeks.

If you have any doubts, consult your doctor, pharmacist, or nurse.
If you stop using Enspryng
Do not stop treatment with Enspryng abruptly without first consulting your doctor. If you have any questions about using this medicine, speak to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Allergic reactions
If you experience any sign of an allergic reaction during or after the injection, inform your doctor immediately or go to the nearest hospital emergency department. Such signs include:

• tightness in the chest or wheezing
• shortness of breath
• fever or chills
• severe dizziness or mild confusion
• swelling of the lips, tongue, or face
• itching, hives, or skin rash.

Do not take the next dose until you have spoken with your doctor and the doctor has told you to continue.
Injection-related reactions (very common: may affect more than 1 in 10 people)
In most cases, these reactions are mild in intensity, but some may be life-threatening.
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, itching, or hives
• feeling of hot flushes
• headache
• irritation, swelling, or pain in the throat
• shortness of breath
• low blood pressure (dizziness and mild confusion)
• fever or chills
• feeling tired
• feeling unwell or diarrhea
• rapid heartbeat, "fluttering," or sensation of a pounding heart (palpitations).

Inform your doctor or nurse immediately if you experience any of the symptoms listed above.
Other side effects
Very common (may affect more than 1 in 10 people)

• headache
• joint pain
• high levels of lipids (fats) in the blood
• low levels of white blood cells in blood tests

Common (may affect up to 1 in 10 people)

• feeling of stiffness
• migraine
• slow heartbeat (bradycardia)
• increased blood pressure
• difficulty sleeping
• swelling in the lower legs, feet, or hands
• skin rash or itching
• allergies or hay fever
• inflammation of the stomach (gastritis), including stomach pain and nausea
• weight gain
• blood tests showing:
  • decreased fibrinogen levels (a protein involved in blood clotting)
  • increased liver enzymes (transaminases, possible sign of liver problems)
  • increased bilirubin levels (possible sign of liver problems)
  • decreased platelet count (which may lead to increased tendency to bleed or bruise)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enspryng

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label of the pre-filled syringe and on the packaging after "Exp". The expiry date refers to the last day of that month.
• 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 their outer packaging to protect the medicine from light and moisture.
• If unopened and kept in the outer packaging, Enspryng may be stored outside the refrigerator at a temperature below 30 °C for a single period of up to 8 days. Do not return Enspryng to the refrigerator.
• Do not use and discard the pre-filled syringe if it has been kept outside the refrigerator for more than 8 days.

Do not use the medicine if it is not clear, if the colour has changed, or if it contains particles. Enspryng is a liquid that ranges from colourless to slightly yellow.
The medicine must be injected immediately after removing the protective cap and within 5 minutes, to prevent the medicine from drying and the needle from becoming blocked. If the pre-filled syringe is not used within 5 minutes after removing the protective cap, it must be disposed of in a puncture-resistant container and a new pre-filled syringe must be used.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enspryng contains

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

Description of the appearance of Enspryng and contents of the pack

• It is a liquid, colourless to slightly yellow.
• Enspryng is an injectable solution.
• Enspryng is available in packs containing 1 pre-filled syringe and in multiple packs consisting of 3 cartons, each containing 1 pre-filled syringe. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg UAB “Roche Lietuva”
N.V. Roche S.A. Tel: +370 5 2546799
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11
България
Рош България ЕООД
Тел: +359 2 818 44 44
Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 12 794 500
Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99
Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050
Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00
Ελλάδα, Κύπρος Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Ελλάδα Tel: +43 (0) 1 27739
Τηλ: +30 210 61 66 100
España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88
France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00
Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01
Ireland, Malta Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Ireland/L-Irlanda Tel: +386 - 1 360 26 00
Tel: +353 (0) 1 469 0700
Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000
Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500
Sverige
Roche AB
Tel: +46 (0) 8 726 1200
Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Links to other websites on rare diseases and related therapeutic treatments are also provided.

Instructions for use

Read these instructions for use:

• before starting to use the pre-filled syringe
• each time the prescription is renewed, as they may contain new information.
• These instructions do not replace discussions with your doctor or nurse about your condition or treatment.
• Your doctor or nurse will decide whether you or your caregiver may administer Enspryng injections at home. In addition, they will show you or your caregiver the correct and safe way to use the syringe before you use it for the first time.
• For any questions, please consult your doctor or nurse.

Important information

• Each syringe is pre-filled with the medicine called Enspryng.
• Each Enspryng carton contains only 1 pre-filled syringe.
• Each pre-filled syringe may be used only once.
• Do not share syringes with other people.
• Do not remove the protective needle cap until you are ready to administer the injection.
• Do not use the syringe if it has been dropped or is damaged.
• Never attempt to disassemble the syringe.
• Do not leave the syringe unattended.
• Do not reuse the same syringe.

Materials needed to administer the injection
Each Enspryng carton contains:

• 1 single-use pre-filled syringe.

You will also need the following materials, which are not included in the package:

• 1 alcohol swab
• 1 sterile cotton ball or gauze pad
• 1 adhesive bandage
• 1 puncture-resistant sharps container for safe disposal of the used needle cap and syringe. See step 21 “Disposal of Enspryng” at the end of these instructions for use.

Enspryng pre-filled syringe
(see Figure A and Figure B)
Before use

Figure A
After use

Figure B
The syringe is equipped with an automatic needle protection device that covers the needle after the injection.
Preparing to use Enspryng

1. Remove the syringe packaging from the refrigerator and place it on a clean, flat work surface (e.g., a table).
2. Check the expiration date printed on the back of the packaging (see Figure C). Do not use the syringe if the expiration date has passed.
3. Verify that the front of the packaging is sealed (see Figure C). Do not use the syringe if the seal is broken. If the expiration date has passed or the seal is broken, go to step 21 “Disposal of Enspryng” and contact your doctor or nurse.

Figure C

4. Open the sealed packaging (see Figure D).

Figure D

5. Carefully remove the syringe from the packaging by holding it by the barrel (see Figure E).
   • Do not turn the carton upside down to remove the syringe.
   • Do not touch the activation wings of the syringe. The syringe could be damaged.
   • Do not hold the syringe by the plunger or the needle protective cap.

Figure E
Check the syringe
(See Figure F)

6. Check the expiration date on the syringe. Do not use the syringe if the expiration date has passed.
7. Check that the syringe is not damaged. Do not use it if it has cracks or is broken.
8. Through the viewing window, check that the liquid is clear and colourless or slightly yellow. Do not administer the medicine if the liquid is cloudy, discoloured, or contains particles.
   • Small air bubbles may be present in the syringe. This is normal and you do not need to remove them.

Figure F
Do not use the syringe if the expiration date has passed, or if the syringe is damaged, or if the liquid is
cloudy, discoloured, or contains particles. Go to step 21 “Disposal of Enspryng” and contact your doctor or nurse.
Allow the syringe to reach room temperature

9. After checking the syringe, leave it on a clean, flat work surface (e.g., a table) for 30 minutes to reach room temperature (see Figure G). It is important to allow the syringe to warm to room temperature, as injecting cold medicine may be uncomfortable and make it harder to push the plunger.
   • Do not try to speed up the warming process by heating the syringe in any way.
   • Do not remove the needle cap while the syringe is warming to room temperature.

Figure G
Handwashing

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

Figure H
Choose the injection site

11. Choose an injection site from:

• the lower abdomen (stomach), or
• the front and middle part of the thighs (see Figure I).

Figure I

• Do not inject within 5 cm of the navel.
• Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or not intact. Choose a different injection site for each new injection. Select a different site for each new injection, at least 2.5 cm away from the previous injection site.

Clean the injection site

12. Wipe the injection site with an alcohol swab and allow it to dry.

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

Figure J
Injecting Enspryng

13. Hold the syringe barrel between your thumb and index finger. With your other hand, remove the protective needle cap. A drop of liquid may appear at the tip of the needle. This is normal and will not affect the dose administered (see Figure K).

• Use the syringe within 5 minutes after removing the protective cap, otherwise the needle may become blocked.
• Do not remove the protective needle cap until you are ready to administer the injection.
• Do not replace the protective cap on the needle after removal, as it may damage the needle.
• After removing the protective cap, do not touch the needle or let it come into contact with any surface.

Figure K

14. Immediately dispose of the protective needle cap into a puncture-resistant sharps container. See step 21 “Disposal of Enspryng”.
15. Hold the syringe barrel between your thumb and index finger. With your other hand, pinch the cleaned area of skin (see Figure L).
16. With a quick motion, like a dart, insert the needle at an angle between 45° and 90° (see Figure L).

• Do not change the angle of injection during the injection.
• Do not reinsert the needle a second time.

Figure L

17. Once the needle is inserted, release the pinched skin.
18. Inject the medicine slowly by gently pushing the plunger all the way down until it touches the activation wings (see Figure M).

Figure M

19. Gently release the plunger and withdraw the needle from the skin at the same angle it was inserted (see Figure N).

Figure N

• At this point, the needle will be covered by the automatic needle protection device. If the needle is not covered, to avoid injury, carefully place the syringe into a puncture-resistant sharps container. See step 21 “Disposal of Enspryng”.

Caring for the injection site

20. There may be slight bleeding at the injection site. Gently press a cotton ball or gauze pad over the site until bleeding stops, but without rubbing. If needed, you may cover the injection site with an adhesive bandage. If the medicine comes into contact with the skin, wash the area with water.

Disposal of Enspryng

21. Do not attempt to recap the syringe. Immediately after use, place the used syringe into a puncture-resistant sharps container (see Figure O). Do not dispose of the syringe in household waste and do not recycle it.

Figure O

• Ask your doctor, nurse, or pharmacist for information on where to obtain a sharps container or what other type of puncture-resistant container you may use to dispose of used syringes and needle caps.
• Dispose of the used sharps container according to instructions provided by your healthcare provider or pharmacist.
• Do not dispose of the sharps container in household waste.
• Do not recycle the sharps container.