Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Evrysdi 5 mg film-coated tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Risdiplam may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Risdiplam
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Evrysdi contains the active substance risdiplam. It is part of a group of medicines known as 'premRNA splicing modifiers'. Evrysdi is used to treat spinal muscular atrophy (SMA) in adults and children.

● SMA is an illness that runs in families – a genetic illness. ● It is caused by a shortage of a protein called 'survival motor neuron' (SMN) in the body. If you do not have enough SMN protein, you lose motor neurons. Motor neurons are nerve cells that control muscles. ● This leads to muscle weakness and wasting. ● This can make everyday movements difficult, such as head and neck control, sitting, crawling and walking. ● The muscles used for breathing and swallowing may also become weaker. How Evrysdi works Evrysdi works by helping the body produce more SMN protein. ● This means you lose fewer motor neurons – this may improve how well muscles work in people with SMA. 1 uk-pil-evrysdi-250708-clean-5mg-fct

In infants with SMA Type 1, Evrysdi may: ● increase how long they live ● reduce the need for a ventilator to help with breathing ● help them be able to keep being fed by mouth. In children (toddlers to adolescents) and adults with SMA Type 2 and 3, Evrysdi may: ● stop muscle control getting worse ● improve muscle control.

2.

What you need to know before you take it

e Evrysdi

Do not take Evrysdi: ● if you 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, pharmacist, or nurse before you take Evrysdi. Warnings and precautions Talk to your doctor, pharmacist, or nurse before you take Evrysdi. Treatment with Evrysdi may harm your unborn baby or may 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 take any other medicines in the future. In particular tell 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 you start treatment with this medicine, your doctor should do a pregnancy test. This is because Evrysdi may harm your unborn baby. ● Do not take this medicine if you are pregnant. ● Do not become pregnant: during your treatment with Evrysdi and for one month after you stop taking Evrysdi. If you do become pregnant during your treatment, tell your doctor straight away. You and your doctor will decide what is best for you and your unborn baby. Contraception For women You must use a highly effective method of birth control: ● while taking this medicine and ● for one month after you stop taking this medicine. 2 uk-pil-evrysdi-250708-clean-5mg-fct

Talk to your doctor about highly effective methods of birth control that you and your partner can use. For men If your partner is a woman who can have children, she must not become pregnant. Use condoms: ● while taking this medicine and ● for 4 months after you stop taking this medicine. Talk to your doctor about highly effective methods of birth control that you and your partner can use. Breast-feeding Do not breast-feed while taking this medicine. This medicine may pass into breast milk and may harm your baby. Talk to your doctor about whether you should stop breast-feeding or if you should stop taking Evrysdi. Male fertility Evrysdi may reduce male fertility during 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 this medicine. Driving and using machines This medicine 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. This means it is essentially 'sodium-free' and can be used by people on a sodium-restricted diet.

3.

How to take Evrysdi

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 will get blister packs of Evrysdi as film-coated tablets, referred to as a 'tablet' in this leaflet. This medicine is also available as an oral solution. Your doctor will help you choose the right one for you. How much Evrysdi to take If you get Evrysdi film-coated tablets, the dose is 5 mg (one tablet) once daily. You 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 Read the 'Instructions for Use' at the end of this leaflet. Follow the instructions carefully. It shows you exactly how to make and take Evrysdi as a mixture. 3 uk-pil-evrysdi-250708-clean-5mg-fct

Take Evrysdi: ● once a day, at around the same time – this will help you remember when to take your medicine ● with or without food. There are two ways your doctor may tell you to take Evrysdi film-coated tablets: ● Take Evrysdi by mouth. Swallow each tablet whole with some water. Do not cut, crush or chew the tablets. Or ● Take Evrysdi by mouth after dispersing it in a small amount of room temperature water. Do not mix Evrysdi with any liquids other than water. Take Evrysdi tablet straight away after mixing with water. If you do not take it within 10 minutes of adding water, throw the mixture away and make a new dose. Do not expose the tablet mixture prepared from the Evrysdi tablet to sunlight. Do not get Evrysdi tablet mixture on your skin or in your eyes. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Do not administer the tablet mixture via a feeding tube. How long to take Evrysdi for Your doctor will tell you how long you need to take Evrysdi for. Do not stop treatment with Evrysdi unless your doctor tells you to. If you take more Evrysdi than you should If you 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 forget to take Evrysdi or vomit after a dose If you forget to take a dose: ● If it is less than 6 hours after you normally take Evrysdi – take the missed dose as soon as you remember. ● If it is over 6 hours from when you 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 are sick (vomit) after taking 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 tablet mixture, dry the area with a dry paper towel and then clean the area with soap and water. Throw away the paper towel in the rubbish and wash your hands well with soap and water. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4.

Possible side effects

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 4 uk-pil-evrysdi-250708-clean-5mg-fct

● ● ●

rash headache fever

Common: may affect up to 1 in 10 people ● feeling sick (nausea) ● mouth sores ● bladder infection ● joint pain Not known: it is not known how often these happen ● inflamed small blood vessels mainly in 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

How to take it

Evrysdi tablets ●

If you are taking Evrysdi tablets, the daily dose is 1 tablet.

●

Take the tablet whole with water or as a liquid by mixing 1 tablet in at least 1 teaspoon (5 ml) of room temperature water.

●

Do not chew, cut, or crush the tablet.

●

Do not mix Evrysdi with any liquids other than water.

●

Do not take Evrysdi tablet mixture if it has been more than 10 minutes since adding water to the tablet. Throw the mixture away according to your local requirements and make a new dose.

●

Do not take an extra dose if you are sick (vomit) at any time after taking Evrysdi.

7 uk-pil-evrysdi-250708-clean-5mg-fct

Get ready to take an Evrysdi tablet Step 1. Wash your hands. (Figure A).

Figure A Step 2. Take out 1 Evrysdi tablet from the blister (Figure B).

Figure B Option A: Swallow the Evrysdi tablet whole

Step A1 Swallow the tablet whole with some water. Do not chew, cut, or crush the tablet Do not swallow with any liquids other than water. Step A2 Wash your hands with soap and water.

8 uk-pil-evrysdi-250708-clean-5mg-fct

Option B: Take Evrysdi tablet mixed in water

What is needed to mix Evrysdi with water: ● 1 Evrysdi tablet ● a small, clean empty cup ● at least 1 teaspoon (5ml) of room temperature water for mixing ● at least 1 tablespoon (15ml) of water for rinsing

Step B1 Put at least 1 teaspoon (5ml) of water in a cup – and add 1 tablet. ● Do not use any liquids other than water, ● Keep the mixture out of sunlight. Step B2 Gently swirl the cup until it is fully mixed – this can take up to 3 minutes (Figure C).

Figure C

Step B3 Drink immediately within 10 minutes of adding water to the tablet (Figure D).

Figure D Step B4 Refill the cup with at least 1 tablespoon (15ml) of water and swirl to get any medicine left in the cup (Figure E). Figure E Step B5 Drink immediately (Figure F).

Figure F Step B6 Wash your hands with soap and water. Storing EVRYSDI ● This medicinal product does not require any special temperature storage conditions. ● Store in the original package in order to protect from moisture. ● Keep Evrysdi and all medicines out of the sight and reach of children.

9 uk-pil-evrysdi-250708-clean-5mg-fct

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

Evrysdi

● ● ●

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

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.

6.

Contents of the pack and other information

What Evrysdi contains ● ● ●

The active substance in the film-coated tablet is risdiplam. Each film-coated tablet contains 5 mg risdiplam. The other ingredients are tartaric acid (E 334), mannitol (E 421), microcrystalline cellulose, silica, colloidal anhydrous (E 551), crospovidone, strawberry flavor and sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b) and yellow iron oxide (E 172).

What Evrysdi looks like and contents of the pack ● ●

Evrysdi tablets are pale yellow film-coated tablets, round and curved, with EVR debossed on one side. Evrysdi is supplied in packs containing 28 x 1 film-coated tablets. There are 4 aluminium perforated unit-dose blisters with 7 tablets each.

  • The blisters strips are each marked with abbreviated names of the day as a reminder to take a daily dose: Mon. Tue. Wed. Thu. Fri. Sat. Sun

5 uk-pil-evrysdi-250708-clean-5mg-fct

Marketing Authorisation Holder Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom This leaflet was last revised in April 2025.

6 uk-pil-evrysdi-250708-clean-5mg-fct

Instructions for Use – Administration Evrysdi film coated tablets This Instructions for Use contains information on how to prepare and take Evrysdi. ● The information in this Instructions for Use is for taking or giving this medicine – but here we just say 'take'. Before you start Read this Instructions for Use before taking Evrysdi film-coated tablets for the first time and each time you get a refill. There may be new information. Evrysdi film-coated tablets can be swallowed whole or mixed with a small amount of room temperature water and taken by mouth. Do not give Evrysdi film-coated tablets with a feeding tube. Important Information ●

Your doctor, pharmacist, or nurse will show you how to prepare and take Evrysdi tablets. Always take Evrysdi tablets exactly as your healthcare provider tells you.

●

Do not take or give this medicine until you have been shown how to properly prepare and take Evrysdi.

●

Wash your hands before and after preparing or taking Evrysdi.

●

Check the expiry date and check the product for damage before use. Do not use if expired or damaged.

●

Do not get the Evrysdi tablet mixture on your skin or in your eyes. If the Evrysdi tablet mixture gets on your skin, wash the area with soap and water. If the tablet mixture gets in your eyes, rinse your eyes with water.

●

Keep the Evrysdi tablet mixture out of sunlight.

●

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

Frequently asked questions about Evrysdi 5 mg film-coated tablets

How do I take Evrysdi 5 mg film-coated tablets?

Evrysdi 5 mg film-coated tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Evrysdi 5 mg film-coated tablets?

The active substance in Evrysdi 5 mg film-coated tablets is risdiplam.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Evrysdi 5 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Evrysdi 5 mg film-coated tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Risdiplam (2 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.

4.2. Posology and method of administration

Treatment with Evrysdi should be initiated by a physician with experience in the management of SMA.

Posology

The recommended once daily dose of Evrysdi film-coated tablet for patients ≥ 2 years of age with ≥ 20 kg body weight is 5 mg.

There is an alternative oral solution available for patients of all age groups or who may require the use of a nasogastric or gastrostomy tube. Refer to the Evrysdi powder for oral solution SmPC. The physician should prescribe the appropriate pharmaceutical form according to the dose required and the patient's needs, including the patient's ability to swallow. For patients with difficulty swallowing a whole tablet, the tablet can be dispersed or the powder for oral solution can be prescribed.

Treatment with a daily dose above 5 mg has not been studied.

Delayed or missed doses

If a planned dose is missed, it should be administered as soon as possible if still within 6 hours of the scheduled dose. Otherwise, the missed dose should be skipped and the next dose should be administered at the regularly scheduled time the next day.

If a dose is not fully swallowed or vomiting occurs after taking a dose of Evrysdi, another dose should not be administered to make up for the incomplete dose. The next dose should be administered at the regularly scheduled time.

Elderly

No dose adjustment is required in elderly patients based on limited data in subjects aged 65 years and older (see section 5.2).

Renal impairment

Risdiplam has not been studied in this population. No dose adjustment is expected to be required in patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. Patients with severe hepatic impairment have not been studied and may have increased risdiplam exposure (see sections 5.1 and 5.2).

Paediatric population

There is no relevant use of Evrysdi film-coated tablets in children < 2 years of age and < 20 kg.

Method of administration

Oral use.

It is recommended that a healthcare professional (HCP) discuss with the patient or caregiver how to prepare the prescribed daily dose prior to administration of the first dose.

Evrysdi is taken orally once a day with or without food at approximately the same time each day.

The film-coated tablets should be swallowed whole or dispersed in a small amount of room temperature water (see Section 6.6). Do not chew, cut, or crush the tablets.

If Evrysdi is dispersed in water, take it immediately. Evrysdi must not be dispersed in any liquid other than water. Discard the prepared mixture if it is not used within 10 minutes of adding water. Do not expose the prepared mixture to sunlight.

If the prepared mixture of Evrysdi spills or gets on the skin, the area should be washed with soap and water.

Do not administer the prepared mixture via a nasogastric or gastrostomy tube. If administration through a nasogastric or gastrostomy tube is required, Evrysdi powder for oral solution should be used.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Potential embryo-foetal toxicity

Embryo-foetal toxicity has been observed in animal studies (see section 5.3). Patients of reproductive potential should be informed of the risks and must use highly effective contraception during treatment and until at least 1 month after the last dose in female patients, and 4 months after the last dose in male patients. The pregnancy status of female patients of reproductive potential should be verified prior to initiating Evrysdi therapy (see section 4.6).

Potential effects on male fertility

Based on observations from animal studies, male patients should not donate sperm while on treatment and for 4 months after the last dose of Evrysdi. Prior to initiating treatment, fertility preservation strategies should be discussed with male patients of reproductive potential (see sections 4.6 and 5.3). The effects of Evrysdi on male fertility have not been investigated in humans.

Excipients

Sodium

Evrysdi contains less than 1 mmol sodium (23 mg) per 5 mg dose, i.e. is essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

Risdiplam is primarily metabolized by hepatic enzymes flavin monooxygenase 1 and 3 (FMO1 and 3), and also by cytochrome P450 enzymes (CYPs) 1A1, 2J2, 3A4, and 3A7. Risdiplam is not a substrate of human multidrug resistance protein 1 (MDR1).

Effects of other medicinal products on risdiplam

Omeprazole had no impact on the pharmacokinetics of risdiplam administered as a tablet. The risdiplam tablet may therefore be administered concomitantly with medication that increases the gastric pH (proton pump inhibitors, H2 antagonists, and antacids).

Co-administration of 200 mg itraconazole twice daily, a strong CYP3A inhibitor, with a single oral dose of 6 mg risdiplam did not exhibit a clinically relevant effect on the PK parameters of risdiplam (11% increase in AUC, 9% decrease in Cmax). No dose adjustments are required when Evrysdi is co-administered with a CYP3A inhibitor.

No drug-drug interactions are expected via the FMO1 and FMO3 pathway.

Effects of risdiplam on other medicinal products

Risdiplam is a weak inhibitor of CYP3A. In healthy adult subjects, oral administration of risdiplam once daily for 2 weeks slightly increased the exposure of midazolam, a sensitive CYP3A substrate (11% increase in AUC, 16% increase in Cmax). The extent of the interaction is not considered clinically relevant, and therefore no dose adjustment is required for CYP3A substrates.

In vitro studies have shown that risdiplam and its major human metabolite M1 are not significant inhibitors of human MDR1, organic anion-transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter 1 and 3 (OAT 1 and 3). However, risdiplam and its metabolite are in vitro inhibitors of the human organic cation transporter 2 (OCT2) and the multidrug and toxin extrusion (MATE)1 and MATE2-K transporters. At therapeutic drug concentrations, no interaction is expected with OCT2 substrates. The effect of co-administration of risdiplam on the pharmacokinetics of MATE1 and MATE2-K substrates in humans is unknown. Based on in vitro data, risdiplam may increase plasma concentrations of medicinal products eliminated via MATE1 or MATE2-K, such as metformin. If co-administration cannot be avoided, drug-related toxicities should be monitored and dosage reduction of the co-administered medicinal product should be considered if needed.

There is no efficacy or safety data to support the concomitant use of risdiplam and nusinersen.

4.6. Fertility, pregnancy and lactation

Patients of reproductive potential

Contraception in male and female patients

Male and female patients of reproductive potential should adhere to the following contraception requirements:

● Female patients of childbearing potential should use highly effective contraception during treatment and for at least 1 month after the last dose.

● Male patients, and their female partners of childbearing potential, should both ensure that highly effective contraception is achieved during treatment and for at least 4 months after the last dose.

Pregnancy testing

The pregnancy status of female patients of reproductive potential should be verified prior to initiating Evrysdi therapy. Pregnant women should be clearly advised of the potential risk to the foetus.

Pregnancy

There are no data from the use of Evrysdi in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Evrysdi is not recommended during pregnancy and in women of childbearing potential not using contraception (see section 4.4).

Breast-feeding

It is not known whether risdiplam is excreted in human breast milk. Studies in rats show that risdiplam is excreted into milk (see section 5.3). As the potential for harm to the breastfed infant is unknown, it is recommended not to breastfeed during treatment.

Fertility

Male patients

Male fertility may be compromised while on treatment, based on nonclinical findings. In rat and monkey reproductive organs, sperm degeneration and reduced sperm numbers were observed (see section 5.3). Based on observations from animal studies, the effects on sperm cells are expected to be reversible upon discontinuation of risdiplam.

Male patients may consider sperm preservation prior to treatment initiation or after a treatment-free period of at least 4 months. Male patients who wish to father a child should stop treatment for a minimum of 4 months. Treatment may be re-started after conception.

Female patients

Based on nonclinical data (see section 5.3), an impact of risdiplam on female fertility is not expected.

4.7. Effects on ability to drive and use machines

Evrysdi has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile

In infantile-onset SMA patients, the most common adverse reactions observed in Evrysdi clinical studies were pyrexia (54.8%), rash (29.0%) and diarrhoea (19.4%).

In later-onset SMA patients, the most common adverse reactions observed in Evrysdi clinical studies were pyrexia (21.7%), headache (20.0%), diarrhoea (16.7%), and rash (16.7%).

The adverse reactions listed above occurred without an identifiable clinical or time pattern and generally resolved despite ongoing treatment in infantile-onset and later-onset SMA patients.

Based on the primary analysis of RAINBOWFISH, the safety profile of Evrysdi in pre-symptomatic patients is consistent with the safety profile of symptomatic infantile-onset and later-onset SMA patients. The RAINBOWFISH study enrolled 26 patients with pre-symptomatic SMA between 16 and 41 days of age at the time of the first dose (weight range 3.1 to 5.7 kg). The median exposure duration was 20.4 months (range: 10.6 to 41.9 months). Limited post-marketing data are available in neonates <20 days of age.

See also section 5.3 for the effects of Evrysdi observed in nonclinical studies.

Tabulated list of adverse reactions

The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Adverse drug reactions from clinical studies (Table 1) are listed by MedDRA system organ class.

Table 1. Adverse drug reactions occurring in patients with infantile-onset and later-onset SMA based on Evrysdi clinical studies

System Organ Class

Infantile-onset SMA

(Type 1)

Later-onset SMA

(Type 2 and 3)

Gastrointestinal disorders

Diarrhoea

Very common

Very common

Nausea

Not applicable

Common

Mouth ulcerations and aphthous ulcers

Common

Common

Skin and subcutaneous tissue disorders

Rash*

Very common

Very common

Nervous system disorders

Headache

Not applicable

Very common

General disorders and administration site conditions

Pyrexia (including hyperpyrexia)

Very common

Very common

Infections and infestations

Urinary tract infection (including cystitis)

Common

Common

Musculoskeletal and connective tissue disorders

Arthralgia

Not applicable

Common

*Includes dermatitis, dermatitis acneiform, dermatitis allergic, erythema, folliculitis, rash, rash erythematous, rash maculo-papular, rash papular

Safety profile in patients previously treated with other SMA-modifying therapies

Based on the primary analysis of the JEWELFISH study, the safety profile of Evrysdi in SMA treatment non-naive patients who received Evrysdi for up to 59 months (including those previously treated with nusinersen [n=76] or with onasemnogene abeparvovec [n=14]) is consistent with the safety profile in SMA treatment-naive patients treated with Evrysdi in the FIREFISH, SUNFISH and RAINBOWFISH studies (see section 5.1).

Post-marketing experience

Cutaneous vasculitis was reported during post-marketing experience. Symptoms recovered after permanent discontinuation of Evrysdi. The frequency cannot be estimated based on available data.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

There is no known antidote for overdosage of Evrysdi. In the event of an overdose, the patient should be closely supervised and supportive care instituted.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • EVRYSDI 0,75 mg/ml prescriptionRISDIPLAMUM · taken by mouth
  • EVRYSDI 5 mg prescriptionRISDIPLAMUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • EvrysdiRisdiplamum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Evrysdi 5 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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