Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - evrysdi

Document Subject

Generated Narrative: MedicinalProductDefinition mpd74c016d307ba635374b9ac3d63d2f85

identifier: http://ema.europa.eu/identifier/EU/1/21/1531/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Evrysdi 0.75 mg/mL powder for oral solution

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-d74c016d307ba635374b9ac3d63d2f85

identifier: http://ema.europa.eu/identifier/EU/1/21/1531/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - evrysdi

Attesters

What is in this leaflet

1. What Evrysdi is and what it is used for
2. What you need to know before you or your child take Evrysdi
3. How to take Evrysdi
4. Possible side effects
5. How to store Evrysdi
6. Contents of the pack and other information

What Evrysdi is

Evrysdi is a medicine that contains the active substance risdiplam.

What is Evrysdi used for

Evrysdi is used to treat spinal muscular atrophy (SMA), a genetic disease.

What spinal muscular atrophy is

SMA is caused by a shortage of a protein called survival motor neuron (SMN) protein in the body. Lack of SMN protein can cause you or your child to lose motor neurons, which are nerve cells that control muscles. This leads to muscle weakness and wasting that can affect everyday movements such as head and neck control, sitting, crawling and walking. The muscles used for breathing and swallowing may also become weaker.

How Evrysdi works

Risdiplam, the active substance in Evrysdi, works by helping the body produce more SMN protein. This means fewer motor neurons are lost, which may improve how well muscles work in people with SMA.

In infants with SMA Type 1 treated in clinical trials for 1 year, Evrysdi has helped to:

• increase how long they live and reduce the need for a ventilator to help with breathing compared to untreated infants with SMA (only 25% of untreated infants would be expected to be alive without the need for permanent ventilation beyond 14 months of age compared to 85% of patients after 1 year of treatment with Evrysdi),
• keep the ability to be fed by mouth in 83% of patients.

In children (toddlers to adolescents) and adults with SMA Type 2 and 3, Evrysdi may maintain or improve muscle control.

Do not take Evrysdi:

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

If you are not sure, talk to your doctor or pharmacist before you or your child take Evrysdi.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you or your child take Evrysdi.

Treatment with Evrysdi may harm your unborn baby or may affect male fertility. See Pregnancy, contraception, breast-feeding and male fertility for more information.

Other medicines and Evrysdi

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines in the future.

In particular tell your doctor, pharmacist or nurse if you are taking or have received in the past any of the following medicines:

• metformin a medicine used to treat type II diabetes
• medicines for the treatment of SMA

Pregnancy, contraception, breast-feeding and male fertility

Pregnancy

• Do not take Evrysdi if you are pregnant. This is because taking this medicine while you are pregnant could harm your unborn baby.
• Before you start treatment with Evrysdi, your doctor should do a pregnancy test. This is because Evrysdi may harm your unborn baby.
• If you do become pregnant during your treatment with Evrysdi, tell your doctor straight away.

You and your doctor will decide what is best for you and your unborn baby.

Contraception

For women

Do not become pregnant:

• during your treatment with Evrysdi and
• for one month after you stop taking Evrysdi.

Talk to your doctor about reliable methods of birth control that should be used during treatment and for one month after you stop treatment.

For men

If your female partner is of childbearing potential, you need to avoid pregnancy. Use reliable methods of birth control (eg. condoms):

• during your treatment with Evrysdi and
• for 4 months after you stop taking Evrysdi.

Talk to your healthcare provider about reliable methods of birth control that should be used.

Breast-feeding

Do not breast-feed while taking this medicine. This is because Evrysdi may pass into breast milk and may, therefore, harm your baby.

Discuss with your doctor if you should stop breast-feeding or if you should stop taking Evrysdi.

Male fertility

Based on findings in animals, Evrysdi may reduce male fertility while on treatment and for up to 4 months after your last dose. If you are planning to have a child, ask your doctor for advice. Do not donate sperm during your treatment and for 4 months after your last dose of Evrysdi.

Driving and using machines

Evrysdi is unlikely to affect your ability to drive and use machines.

Evrysdi contains sodium

Evrysdi contains a small amount of sodium (salt) - there is less than 1 mmol (23 mg) sodium even at the highest daily dose of 5 mg (6.6 mL of 0.75 mg/mL oral solution). This means it is essentially sodium-free and can be used by people on a sodium-restricted diet.

Evrysdi contains 0.375 mg of sodium benzoate per mL. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Evrysdi contains isomalt

Evrysdi contains 2.97 mg of isomalt per mL. If you have been told by your doctor that you or your child have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You should receive Evrysdi as a liquid in a bottle. Do not use if the medicine in the bottle is a powder, and contact your pharmacist.

You must also carefully read and follow the enclosed Instructions for use booklet on how to take or give Evrysdi.

How much Evrysdi to take

• Adolescents and adults: The daily dose of Evrysdi is 5 mg (6.6 mL of the oral solution).
• Infants and children: Your doctor will choose the right dose of Evrysdi based on your child s age and weight.

You or your child must take your daily dose as instructed by your doctor. Do not change the dose without speaking with your doctor.

When and how to take Evrysdi

• Evrysdi is a liquid which is prepared by the pharmacist, and is referred to as a solution or medicine in this leaflet.
• Take Evrysdi once daily after a meal at around the same time each day. This will help you remember when to take your medicine.
• Drink water after taking the medicine. Do not mix the medicine with milk or formula milk.
• Take or give Evrysdi immediately after it is drawn up into the oral syringe. If it is not taken within 5 minutes, discard the medicine from the oral syringe, and withdraw a new dose
• If Evrysdi gets on you or your child s skin, wash the area with soap and water.

Read the Instructions for use booklet

A booklet with Instructions for use is included in the pack. It shows you how to withdraw your dose using the re-usable oral syringe given to you. You (or your child) can take the medicine:

• by mouth, or
• through a gastrostomy tube, or
• through a nasogastric tube.

How long to take Evrysdi for

Your doctor will tell you how long you or your child need to take Evrysdi for. Do not stop treatment with Evrysdi unless your doctor tells you to.

If you or your child take more Evrysdi than you should

If you or your child take more Evrysdi than you should, talk to a doctor or go to hospital straight away. Take the medicine pack and this leaflet with you.

If you or your child forget to take Evrysdi or vomits after a dose

If it is within 6 hours of when you or your child normally take Evrysdi, take the missed dose as soon as you remember.

If it is over 6 hours from when you or your child normally take Evrysdi, skip the missed dose and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you or your child vomits after taking a dose of Evrysdi, do not take an extra dose. Instead, take the next dose at the usual time the next day.

If you spill Evrysdi

If you spill Evrysdi, dry the area with a dry paper towel and then clean the area with soap and water. Throw away the paper towel in the waste and wash your hands well with soap and water.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

• diarrhoea
• rash
• headache
• fever
  Common: may affect up to 1 in 10 people
• nausea
• mouth sores
• bladder infection
• joint pain

The following side effect has been reported since the marketing of Evrysdi but the frequency for it to occur is not known:

• inflammation of small blood vessels mainly affecting the skin (cutaneous vasculitis).

Reporting of side effects

If you or your child get any side effects, talk to your doctor or 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.
• Store the oral solution in a refrigerator (2 to 8 C). If necessary, you or your caregiver may store the oral solution at room temperature (below 40 C) for no more than a total of 120 hours (5 days). Return the oral solution to the refrigerator when it is no longer necessary to keep the bottle at room temperature.
• Monitor the total time outside the refrigerator (below 40 C). As mentioned above, the sum of time intervals outside the refrigerator must not exceed 120 hours.
• The oral solution is stable for 64 days after the pharmacist prepares it when stored in the refrigerator at 2 C to 8 C. The pharmacist will write the date of expiration on the bottle label and on the original carton after Discard after . Do not use the solution past this Discard after
  date or discard the medicine if the bottle has been stored at room temperature (below 40 C) for more than a total of 120 hours (5 days).
• Discard the medicine if the bottle has been stored for any period of time at above 40 C.
• Keep the medicine in the original bottle to protect from light.
• Keep the medicine bottle upright, with the cap tightly closed.
• Once you have drawn up the medicine into the oral syringe, use Evrysdi straight away. Do not store the Evrysdi solution in the 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 Evrysdi contains

• The active substance in the oral solution is risdiplam.
• Each mL of the oral solution contains 0.75 mg risdiplam.
• The other ingredients are mannitol (E 421), isomalt (E 953), strawberry flavour, tartaric acid (E 334), sodium benzoate (E 211), macrogol/polyethylene glycol 6000, sucralose, ascorbic acid (E 300), disodium edetate dihydrate (see Section 2 Evrysdi contains sodium and Evrysdi contains isomalt ).

What Evrysdi looks like and contents of the pack

• Powder for oral solution, which is delivered as an oral solution after preparation by the pharmacist.
• The solution is a greenish yellow to yellow, strawberry flavoured oral solution, the volume of the solution is 80 mL.
• Each carton contains 1 bottle, 1 press-in bottle adaptor, two 1-mL, two 6-mL and one 12-mL re- usable amber oral syringes with markings to help you withdraw the right dose.

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 2 474 5Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 1 279 4Danmark
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

Other sources of information

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