Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - enspryng

Document Subject

Generated Narrative: MedicinalProductDefinition mp0d7ee15ee10dc2578a331f45f3babb36

identifier: http://ema.europa.eu/identifier/EU/1/21/1559/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Enspryng 120 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0d7ee15ee10dc2578a331f45f3babb36

identifier: http://ema.europa.eu/identifier/EU/1/21/1559/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - enspryng

Attesters

Instructions for use

What is in this leaflet

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

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 attach to a specific substance in the body.

What Enspryng is used for

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

What is NMOSD

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.

How Enspryng works

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.

Do not use Enspryng

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

If the above applies to you or you are not sure, do not use Enspryng and talk to your doctor, pharmacist or nurse.

Warnings and precautions

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).

Infections

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:

• 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.

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.

Vaccinations

Tell your doctor if you have recently been given any vaccine or might be given a vaccine in the near future.

• Your doctor will check if you need any vaccines before you start Enspryng.
• Do not have live or live attenuated vaccines (for example BCG for tuberculosis or vaccines against yellow fever) while you are being treated with Enspryng.

Liver enzymes

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:

• yellowing of the skin and the whites of the eyes (jaundice)
• dark-coloured urine
• feeling and being sick
• abdominal pain

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.

Children and young people

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.

Other medicines and Enspryng

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

How much Enspryng to use

Each injection contains 120 mg of satralizumab. The first injection will be given under the supervision of your 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 . Continue with the injections once every 4 weeks for as long as your doctor tells you to.

How to use Enspryng

• Enspryng is given by injection under the skin (sub-cutaneously).
• Inject the entire content of the syringe each time.

At the start, your doctor or nurse may inject Enspryng. However, your doctor may decide that you or an adult caregiver can inject Enspryng.

• You or your caregiver will get training on how to inject Enspryng.
• Talk to your doctor or nurse if you or your caregiver have any questions about giving injections.

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

If you use more Enspryng than you should

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.

If you forget to use Enspryng

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:

• for loading doses 2 weeks later
• for maintenance doses 4 weeks later

Check with your doctor, pharmacist or nurse if you are not sure.

If you stop using Enspryng

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.

Allergic reactions

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:

• 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. 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:

• 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).

Tell your doctor or nurse straight away if you have any of the signs above.

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 your 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)

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 pre-filled syringe label and carton 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 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, 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.

What Enspryng contains

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

What Enspryng looks like and contents of the pack

• It is a colourless to slightly yellow liquid.
• Enspryng is a solution for injection.
• Each pack of Enspryng contains 1 pre-filled syringe. Each multipack of Enspryng contains 3 (3 packs of 1) pre-filled syringes. Not all pack sizes may 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien
N.V. Roche S.A.
T l/Tel: +32 (0) 2 525 82 Lietuva
UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg
(Voir/siehe Belgique/Belgien)
esk republika
Roche s. r. o.
Tel: +420 - 2 20382Magyarorsz g
Roche (Magyarorsz g) Kft.
Tel: +36 - 12 794 Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 Malta
(see Ireland )
Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438Eesti
Roche Eesti O
Tel: + 372 - 6 177 Norge
Roche Norge AS
Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich
Roche Austria GmbH
Tel: +43 (0) 1 27Espa a
Roche Farma S.A.
Tel: +34 - 91 324 81 Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 France
Roche
T l: +33 (0) 1 47 61 40 Portugal
Roche Farmac utica Qu mica, Lda
Tel: +351 - 21 425 70 Hrvatska
Roche d.o.o.
Tel: +385 1 4722 Rom nia
Roche Rom nia S.R.L.
Tel: +40 21 206 47 Ireland
Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0Slovenija
Roche farmacevtska dru ba d.o.o.
Tel: +386 - 1 360 26 sland
Roche Pharmaceuticals A/S
c/o Icepharma hf
S mi: +354 540 8Slovensk republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638Italia
Roche S.p.A.
Tel: +39 - 039 2Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 K
. . & .
: +357 - 22 76 62 Sverige
Roche AB
Tel: +46 (0) 8 726 1Latvija
Roche Latvija SIA
Tel: +371 - 6 7039United Kingdom (Northern Ireland)
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: