Evrysdi (Risdiplam)
Complete patient guide for uses, dosage, side effects, and safety information
Quick Facts
What Is Evrysdi Used For?
Evrysdi contains risdiplam, which is used to treat spinal muscular atrophy (SMA), a genetic condition that affects nerve and muscle function.
Primary Uses
Evrysdi treats spinal muscular atrophy (SMA), a genetic condition caused by a shortage of survival of motor neuron (SMN) protein. This protein shortage leads to loss of motor neurons, causing muscle weakness and wasting that can affect basic activities like head control, sitting, crawling, walking, breathing, and swallowing.
How It Works
Evrysdi works as a selective SMN2 gene splicing modifier, helping your body make more SMN protein and maintain protein levels throughout the body with continued use. This reduces nerve cell loss and may improve muscle strength and function across different ages and SMA types. In infants, it improves survival, preserves swallowing, increases likelihood of achieving motor milestones, and reduces hospitalization and need for breathing support. In children and adults, it may maintain or improve motor function over time.
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How to Take Evrysdi
Take Evrysdi once daily at approximately the same time each day, with or without food. Your doctor will help you choose between the liquid solution or tablet form.
Dosage Instructions
For adults and adolescents: 5 mg daily (6.6 mL of solution or one 5 mg tablet). For infants and children: Your doctor will determine the dose based on age and weight. Tablets are available for patients 2 years or older weighing 20 kg or more. Take exactly as prescribed – do not change the dose without speaking to your doctor. If you don't swallow the full dose or vomit after taking it, don't take an extra dose; just take the next dose at the usual time.
What If You Miss a Dose?
If you miss a dose: Take it as soon as you remember if it's within 6 hours of your usual time. If it's been more than 6 hours, skip the missed dose and take your next dose at the usual time. Never take a double dose to make up for a missed one.
Important: Never take a double dose to make up for a missed dose. Use only the oral syringes provided with the solution as they're specially designed to protect the medicine from light.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- constipation or diarrhea
- nausea and vomiting
- upper stomach pain
- heartburn, difficulty swallowing, chronic cough
- skin rash
- mouth and lip ulcers
- eczema
- cough
- runny or stuffy nose
- fever
- teething
- headache
- joint swelling and pain
- urinary tract infection
- respiratory infections
- ear infection
- gastroenteritis
Seek immediate medical attention if you experience:
- difficulty breathing, rapid breathing or shortness of breath
- increased heart rate
- blue lips, fingertips or skin
- watery or bloody diarrhea
- bleeding into the skin
- skin hives or skin ulcers
- joint dislocation
- bloody urine
- curved spine (scoliosis)
- lung infections with fever and blood in phlegm
- blood vessel inflammation in skin
- dehydration
- undescended testicle
Important Warnings
There are important safety considerations before starting Evrysdi, especially regarding pregnancy, fertility, and certain medical conditions.
Who Should Not Take Evrysdi
Do not take Evrysdi if you are allergic to risdiplam or any of the ingredients listed in the medication guide.
Medical Conditions to Discuss
Tell your doctor if you have: kidney or liver disorders, eye structure issues, Type 0 or IV SMA diagnosis, are older than 60 years, or have any other medical conditions. Also inform your doctor about all other medicines you take.
Pregnancy and Breastfeeding
Evrysdi could harm your unborn baby. Women must use highly effective contraception during treatment and for at least 1 month after stopping. Men must use contraception during treatment and for at least 4 months after stopping if their partner can become pregnant. Your doctor may do a pregnancy test before starting treatment. Do not breastfeed while taking Evrysdi as it may pass into breast milk and harm your baby. Men should not donate sperm during treatment and for at least 4 months after stopping as Evrysdi may affect male fertility.
Drug Interactions
Evrysdi can interact with other medications and may affect your eyes when combined with certain drugs.
- metformin (Evrysdi may increase its effect)
- fexofenadine (Evrysdi may increase its effect)
- medicines that affect the eye (tell your doctor about these)
Alcohol & Driving
Evrysdi is unlikely to affect your ability to drive or operate machinery.
Driving and Operating Machinery
Evrysdi is unlikely to affect your ability to drive and use machines.
Storage
Solution: Store in refrigerator at 2°C to 8°C (do not freeze) in original bottle. Can be stored at room temperature (below 40°C) for maximum 5 days total. Keep bottle upright and tightly closed. Use within 64 days of preparation. Once in syringe, use immediately – do not store in syringe. Tablets: Store below 30°C in original package to protect from moisture.
Overdose Information
If you think you have taken too much Evrysdi, seek urgent medical attention immediately. Call the Poisons Information Centre (13 11 26), contact your doctor, or go to the nearest hospital emergency department. Take the medicine pack and this leaflet with you, even if you have no symptoms.
Frequently Asked Questions
Evrysdi works by helping your body make more SMN protein with continued use. In infants, it improves survival and motor milestones, while in children and adults it may maintain or improve motor function over time. Your doctor will monitor your progress.
Yes, you can take Evrysdi with or without food. For breastfed babies, you can give Evrysdi before or after breastfeeding.
If you miss a dose within 6 hours of your usual time, take it as soon as you remember. If it's been more than 6 hours, skip the missed dose and take your next dose at the usual time. Never take a double dose.
Do not stop treatment with Evrysdi unless your doctor tells you to. It's important to continue taking it as prescribed to maintain SMN protein levels in your body.
Avoid getting Evrysdi on your skin. If it does get on your skin, wash the area immediately with soap and water. If it gets in your eyes, rinse with water.
Store the solution in the refrigerator at 2°C to 8°C in the original bottle. It can be kept at room temperature (below 40°C) for maximum 5 days total. Store tablets below 30°C in the original package.
Yes, women should use highly effective contraception during treatment and for at least 1 month after stopping. Men should use contraception during treatment and for at least 4 months after stopping if their partner can become pregnant.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.