Uses
What is Evrysdi used for?
Evrysdi (risdiplam) is commonly used for the treatment of spinal muscular atrophy (SMA). This is a nervous system disorder that can lead to muscle weakness or muscle loss.
Learn more about Evrysdi for SMA.
Evrysdi may also be used for other conditions as determined by your healthcare provider.
How does Evrysdi work (mechanism of action)?
People with spinal muscular atrophy (SMA) have two copies of a broken gene. Problems with this gene can lead to problems having enough of a specific kind of protein that is needed to help muscles work correctly. Evrysdi helps make more of the protein.
How is Evrysdi supplied (dosage forms)?
Brands and other names
- Evrysdi
Dosage forms and strengths
- 0.75 mg/mL oral solution
- 5 mg oral tablets
How should I store Evrysdi?
Oral Liquid. Evrysdi oral liquid comes as a powder that is mixed with water by your pharmacist or another healthcare provider to make a liquid before dispensing it to you. Keep the liquid in the original container to protect from light.
Store Evrysdi oral liquid in a refrigerator between 36 F to 46 F (2 C to 8 C). Do not freeze or expose to a temperature higher than 104 F (40 C). If needed, the medicine can be kept at room temperature up to 104 F (40 C) for short periods of time. The medicine can be removed from and returned to a refrigerator. The total combined amount of time that the liquid can be at room temperature is five days. If you accidentally leave your medicine at room temperature, place your medicine back in the refrigerator as long as it has been five days or less at room temperature. Keep the bottle in an upright position with the cap tightly closed. The liquid is good for 64 days, as long as it has been kept in the refrigerator. Throw away any liquid after the expiration date written on the bottle or if it has been stored at room temperature for more than a total combined time of five days.
Oral Tablet. Evrysdi oral tablet should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep the bottle tightly closed to protect it from moisture.
Side Effects
What are the most common side effects of Evrysdi?
The most common side effects of Evrysdi are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Fever
- Diarrhea
- Rash
- Upper and lower respiratory infection
- Constipation
- Vomiting
- Cough
There may be other side effects of Evrysdi that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Evrysdi?
While less common, the most serious side effects of Evrysdi are described below, along with what to do if they happen.
Severe Allergic Reactions. Evrysdi may cause allergic reactions, which can be serious. Stop taking Evrysdi and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Warnings & Precautions
Who should not use Evrysdi?
Allergies to Ingredients. People who are allergic to any of the following should not take Evrysdi.
- Evrysdi
- Risdiplam
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Evrysdi.
What should I know about Evrysdi before using it?
Do not take Evrysdi unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Evrysdi with other people, even if they have the same condition as you. It may harm them.
Keep Evrysdi out of the reach of children. Since the liquid form of this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.
Evrysdi comes as a tablet that is taken by mouth or a liquid that is taken by mouth or through a feeding tube. Make sure that you or a caregiver understands how to properly prepare and take Evrysdi. If you have any questions, talk to your healthcare provider.
If you are taking Evrysdi oral liquid, use the reusable syringe that is given to you to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Take Evrysdi right away after you draw up the liquid into the reusable syringe. Throw the dose away and draw up a new one if it has been longer than five minutes since you drew up the liquid and you have not taken the dose yet. After you take your dose, drink water to make sure you have completely swallowed the liquid.
If you are taking Evrysdi oral tablets, do not chew, cut, or crush them. Swallow the tablet whole with water. You may also mix the tablet in five milliliters (one teaspoon) of filtered water. It should be taken right away after mixing with water. Ask your pharmacist or other healthcare provider how to do this properly. Wash your hands before and after handling or taking the tablet.
Do not get this medicine on your skin or in your eyes. If you do get the medicine on your skin, wash the area well with soap and water. If the medicine gets in your eyes, rinse them with water.
If you are able to father a baby, Evrysdi may affect your ability to do so. Talk with your healthcare provider if you may possibly want to father a baby someday.
What should I tell my healthcare provider before using Evrysdi?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Evrysdi is right for you.
Other Medicines and Supplements. Evrysdi may interact with other medicines and supplements. Before taking Evrysdi, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Evrysdi may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You may need a negative pregnancy test before starting Evrysdi. If you can become pregnant, use effective birth control while taking Evrysdi and for at least one month after the last dose.
Your healthcare provider will advise you if you should take Evrysdi while you are pregnant or trying to get pregnant. If you become pregnant while taking Evrysdi, you can sign up for the Evrysdi registry by calling 833-760-1098 or by visiting www.evrysdipregnancyregistry.com. This registry collects safety information about the use of Evrysdi during pregnancy.
Breastfeeding. It is not known if Evrysdi passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Evrysdi while breastfeeding.
How can I get more information about Evrysdi?
For more information about Evrysdi, you can visit the manufacturer’s website at www.evrysdi.com or call them at 877-436-3683.
Interactions
Does Evrysdi interact with foods or drinks?
Evrysdi oral liquid should not be mixed with formula or milk.
It is unknown if drinking alcohol will affect Evrysdi.
Does Evrysdi interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are taking metformin, which is a medicine used to treat diabetes, before taking Evrysdi.
Evrysdi may alter the blood levels of some other medicines. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Evrysdi. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Evrysdi?
If you or someone else has used too much Evrysdi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Evrysdi?
If you miss your dose of Evrysdi, you should take it as soon as possible if it has been six hours or less since the time for your dose. If it has been more than six hours since you missed your dose, then you should skip that day’s dose. Do not take another dose if you vomit or do not fully swallow your dose. Do not take double or extra doses.