Evrysdi (Risdiplam)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Evrysdi Used For?
Evrysdi contains risdiplam, a medication specifically designed to treat spinal muscular atrophy (SMA), a genetic condition that affects nerve function and muscle strength.
Primary Uses
Evrysdi is used to treat spinal muscular atrophy (SMA), a genetic condition people are born with that causes muscle weakness and wasting due to a shortage of survival of motor neuron (SMN) protein. This affects basic activities like head control, sitting, crawling, walking, breathing, and swallowing.
How It Works
Evrysdi works by helping your body make more SMN protein and maintain SMN protein levels throughout the body with continued use. This reduces the loss of nerve cells and may improve muscle strength and function. In infants, it improves survival, preserves swallowing, improves likelihood of achieving motor milestones, and reduces hospitalization needs. In children and adults, it may maintain or improve motor function over time.
Good to know: Evrysdi works to maintain SMN protein levels throughout the body with continued use, potentially improving muscle strength and function across different ages and SMA types.
How to Take Evrysdi
Evrysdi comes as either an oral solution or film-coated tablets. Take it once daily at approximately the same time each day, with or without food.
Dosage Instructions
For adults and adolescents: 5 mg daily (6.6 mL of oral 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. Always follow your doctor’s instructions exactly. 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 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 the next day. 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. If you vomit after taking Evrysdi, don’t take an extra dose.
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 and difficulty swallowing
- chronic cough
- skin rash
- mouth and lip ulcers
- eczema
- 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
- chest tightness and wheezing
- airway infection with fever and chills
- skin inflammation with bleeding into skin
- skin hives or ulcers
- bloody urine
- joint dislocation
- curved spine (scoliosis)
- dehydration
- undescended testicle
Important Warnings
There are several important safety considerations before starting Evrysdi treatment.
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, have been diagnosed with Type 0 or IV SMA, are older than 60 years, or have any other medical conditions.
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 could become pregnant. Do not breastfeed while taking Evrysdi as it may pass into breast milk and harm your baby. Your doctor may do a pregnancy test before starting treatment.
Male Fertility: Evrysdi may affect fertility in men. Do not donate sperm during treatment and for at least 4 months after stopping treatment.
Drug Interactions
Evrysdi may interact with certain medications and affect how they work in your body.
Important: Tell your doctor about all medicines, vitamins, and supplements you take, including those bought without prescription.
- metformin – Evrysdi may increase its effect
- fexofenadine – Evrysdi may increase its effect
- medicines that affect the eye – tell your doctor if taking 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, but always be aware of how the medication affects you personally.
Storage
For oral 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. For 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 feel fine.
Frequently Asked Questions
Yes, you can take Evrysdi with or without food. Take it at approximately the same time each day to help you remember.
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. The medication works by maintaining SMN protein levels with continued use.
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.
The oral solution can be stored in the refrigerator for up to 64 days after preparation. It can be kept at room temperature (below 40°C) for no more than 5 days total. Once in the syringe, use it immediately.
No, do not cut, crush, or chew the tablets. You can either swallow them whole with water or disperse them in non-chlorinated drinking water as instructed by your doctor.
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 could 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.