Evrysdi 5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Evrysdi 5 mg film-coated tablets

risdiplam

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you or your child experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
• The information in this leaflet is intended for you, your caregiver, or your child, but in the leaflet only the term “you” is used.

Contents of the leaflet

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

1. What Evrysdi is and what it is used for

Evrysdi contains the active substance risdiplam, which belongs to a group of medicines known as "messenger ribonucleic acid precursor splicing modifiers".

Evrysdi is used to treat spinal muscular atrophy (SMA) in adults and children.

• SMA is an inherited disease: a genetic disorder.
• It is caused by a deficiency in the body of a protein called "survival motor neuron protein" (SMN).

The absence of sufficient SMN protein leads to the loss of motor neurons.

Motor neurons are nerve cells that control muscles.

• This causes muscle weakness and loss of muscle mass.
• This can make it more difficult to perform everyday movements, such as head and neck control, sitting, crawling, and walking.
• The muscles used for breathing and swallowing may also become weakened.

How Evrysdi works

Evrysdi works by helping the body produce more SMN protein.

• This means that fewer motor neurons are lost, which may improve muscle function in people with SMA.

In infants with Type 1 SMA, Evrysdi may:

• increase lifespan,
• reduce the need for a ventilator to assist with breathing,
• help them continue to be fed by mouth.

In children (from infants to adolescents) and adults with Type 2 and Type 3 SMA, Evrysdi may:

• prevent worsening of muscle control,
• improve muscle control.

2. What you need to know before taking Evrysdi

Do not take Evrysdi:

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

If in doubt, consult your doctor, pharmacist, or nurse before starting to take Evrysdi.

Warnings and precautions

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

Treatment with Evrysdi may harm an unborn baby or affect male fertility. See "Pregnancy", "Contraception", and "Male fertility" for more information.

Other medicines and Evrysdi

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

In particular, inform your doctor, pharmacist, or nurse if you are taking or have ever taken any of the following medicines:

• metformin – a medicine used to treat type 2 diabetes
• medicines for the treatment of SMA

Pregnancy

Before starting treatment with this medicine, your doctor must perform a pregnancy test. This is because Evrysdi could harm the unborn baby.

• Do not take this medicine if you are pregnant.

• You must not become pregnant:

• during treatment with Evrysdi and

• for one month after stopping Evrysdi.

If you become pregnant during treatment, inform your doctor immediately. You and your doctor will decide what is best for you and the unborn baby.

Contraception

For women

You must use a highly effective method of contraception:

• while taking this medicine and
• for one month after stopping this medicine.

Talk to your doctor about highly effective contraceptive methods you and your partner can use.

For men

If your partner is a woman of childbearing age, she must not become pregnant.

You must use a condom:

• while taking this medicine and
• for 4 months after stopping this medicine.

Talk to your doctor about highly effective contraceptive methods you and your partner can use.

Breastfeeding

Do not breastfeed while taking this medicine. This medicine may pass into breast milk and harm the baby.

Consult your doctor to determine whether you should stop breastfeeding or stop taking Evrysdi.

Male fertility

Evrysdi may reduce male fertility during treatment and for 4 months after the last dose.

• If you are planning to have a child, consult your doctor for advice.
• Do not donate sperm during treatment or for 4 months after the last dose of this medicine.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

Evrysdi contains sodium

Evrysdi contains a small amount of sodium (salt) – less than 1 mmol (23 mg) of sodium. This means it is essentially "sodium-free" and can be used by people on a low-sodium diet.

3. How to take Evrysdi

Follow exactly the instructions for administration of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You have received Evrysdi in the form of film-coated tablets in blister packs, referred to as "tablets" in this leaflet. This medicine is also available as an oral solution. Your doctor will have helped you choose the most suitable option for you.

How much Evrysdi to take

Evrysdi tablets are used in patients aged 2 years or older, or who weigh 20 kg or more.

For Evrysdi tablets, the dose is 5 mg (one tablet) once daily.

You should take the daily dose prescribed by your doctor.

• Do not change the dose without speaking to your doctor.

When and how to take Evrysdi

Read the "Instructions for use" at the end of this leaflet. Follow the instructions carefully. They explain exactly how to prepare and take Evrysdi as a mixture.

Take Evrysdi:

• once daily, at approximately the same time each day. This will help you remember when to take the medicine.
• with or without food.

Your doctor may instruct you to take Evrysdi tablets in one of two ways:

• Take Evrysdi orally. Swallow each tablet whole with a little water.

• Do not split, crush, or chew the tablets.

Or

• Take Evrysdi orally or via an 8 French or larger feeding tube after dispersing it in a small amount of room temperature water.

• Do not mix Evrysdi with any liquid other than water.

• Take the Evrysdi tablet immediately after it has been completely mixed with water. If you do not take it within 10 minutes after adding water, discard the mixture and prepare a new dose.

• Do not expose the prepared tablet mixture to direct sunlight.

• Avoid contact of the Evrysdi tablet mixture with skin and eyes. If Evrysdi comes into contact with the skin, wash the area with soap and water. If Evrysdi comes into contact with your eyes, rinse them thoroughly with water.

How long to take Evrysdi

Your doctor will tell you how long you should take Evrysdi. Do not stop treatment with Evrysdi unless instructed by your doctor.

If you take more Evrysdi than you should

If you take more Evrysdi than you should, contact a doctor or go to hospital immediately.

• Take the medicine packaging and this leaflet with you.

If you forget to take Evrysdi or vomit after taking a dose

If you forget to take a dose:

• If less than 6 hours have passed since your usual time for taking Evrysdi, take the missed dose as soon as you remember.
• If more than 6 hours have passed since your usual time for taking Evrysdi, skip the missed dose and take the next dose at your regular time. Do not take a double dose to make up for the missed dose.

If you vomit after taking Evrysdi:

• Do not take an additional dose. Instead, take the next dose at your usual time the following day.

If you spill Evrysdi

If you spill the Evrysdi tablet mixture, wipe up the spill with a dry paper towel and clean the area with soap and water. Dispose of the paper towel in the trash and wash your hands thoroughly with soap and water.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience 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 ulcers
• bladder infection
• joint pain

Frequency not known: frequency is unknown

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Evrysdi

• Keep this medicine out of the sight and reach of children.
• This medicine does not require special storage temperature conditions.
• Store in the original packaging to protect it from moisture.

Do not use this medicine after the expiry date stated on the packaging and on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Evrysdi

• The active substance in the tablet is risdiplam.
• Each tablet contains 5 mg of risdiplam.
• The other components are tartaric acid (E 334), mannitol (E 421), microcrystalline cellulose, colloidal anhydrous silica (E 551), crospovidone, strawberry flavour [natural flavouring substances, flavouring preparations, corn maltodextrin, modified waxy corn starch (E1450)], sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b) and yellow iron oxide (E 172).

Appearance of Evrysdi and contents of the pack

• Evrysdi tablets are pale yellow, film-coated, round and biconvex tablets, with "EVR" engraved on one side.

• Evrysdi is available in packs containing 28 x 1 tablet. Each pack contains 4 single-dose aluminum blister strips, each containing 7 tablets.

• Each blister strip is labelled with abbreviated days of the week as a reminder for taking a daily dose:

Mon Tue Wed Thu Fri Sat Sun

Marketing Authorization 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of latest review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

DIRECTIONS FOR USE – ADMINISTRATION

Evrysdi film-coated tablets

These Directions for Use contain information on how to prepare and take Evrysdi.

The information in these Directions for Use is intended for the intake or administration of this medicine, but in this document we only refer to "taking".

Read these Directions for Use before taking Evrysdi film-coated tablets for the first time and each time you are dispensed a new supply. They may contain new information.

Evrysdi film-coated tablets may be swallowed whole or mixed with a small amount of water and taken orally, or they may be administered through a feeding tube (i.e., a nasogastric tube [NG tube] or gastrostomy tube [G tube]).

• Your doctor, pharmacist, or nurse will teach you how to prepare and take Evrysdi tablets. Always take Evrysdi tablets exactly as your healthcare professional has instructed you.
• Do not take or administer this medicine until you have been properly taught how to prepare and take Evrysdi.
• Wash your hands before and after preparing or taking Evrysdi.
• Check the expiration date and ensure the medicine is not damaged before use. Do not use if expired or damaged.
• Avoid contact of the Evrysdi tablet mixture with skin and eyes. If the Evrysdi tablet mixture comes into contact with skin, wash the area with soap and water. If the mixture comes into contact with your eyes, rinse them thoroughly with water.
• Protect the Evrysdi tablet mixture from sunlight.
• If you spill the Evrysdi tablet mixture, dry the area with a dry paper towel and clean it with soap and water. Dispose of the paper towel in the trash and wash your hands thoroughly with soap and water.

• If you take Evrysdi in tablet form, the daily dose is 1 tablet.
• Swallow the tablet whole with water or in liquid form by mixing 1 tablet with at least 1 teaspoon (5 ml) of room temperature water.
• Do not chew, split, or crush the tablet.
• Do not mix Evrysdi with any liquid other than water.
• Do not take the Evrysdi tablet mixture if more than 10 minutes have passed since water was added to the tablet. Discard the mixture according to local requirements and prepare a new dose.
• Do not take an additional dose if you vomit at any time after taking Evrysdi.

What is needed to mix Evrysdi with water:

• 1 Evrysdi tablet
• 1 empty and clean small glass
• at least 1 teaspoon (5 ml) of room temperature water for mixing
• at least 1 tablespoon (15 ml) of water for rinsing