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Risdiplam (By mouth)

Risdiplam (ris-DIP-lam)

Treats spinal muscular atrophy (progressive muscle wasting).

Brand Name(s):

Evrysdi

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to risdiplam, or if you are pregnant.

How to Use This Medicine:

Liquid, Tablet

Your doctor will tell you how much medicine to use. Do not use more than directed.
Measure the oral liquid with the oral syringe and take it within 5 minutes. Throw away any unused medicine after 5 minutes. Do not save leftover medicine.
Swallow the tablet whole with water. Do not chew, cut, or crush it.
Take the medicine about the same time each day.
If you are giving the oral liquid to an infant, give it before or after breastfeeding. Do not mix it with milk or formula.
Oral liquid:
- Remove the cap by pushing it down and twisting the cap to the left.
- Push the plunger of the oral syringe all the way down to remove any air. Place the bottle on a flat surface and insert the syringe tip into the bottle adapter.
- Carefully turn the bottle upside down with the syringe tip firmly inserted into the adapter. Slowly pull back on the plunger until the top of the plunger lines up with the marking on the barrel of the syringe that matches the needed dose. Hold the plunger in place to keep it from moving.
- Turn the bottle into an upright position. Remove the oral syringe from the bottle adapter by pulling straight up. Check for large air bubbles in the syringe. If you see air bubbles, insert the syringe tip into the bottle adapter and push the plunger all the way down to let the medicine flow back into the bottle. Repeat the steps to withdraw your prescribed medicine dose.
- Put the cap back on. Do not remove the bottle adapter.
- Place the tip of the syringe into the mouth against the inside of the cheek. Slowly push the plunger all the way down to give full dose. Drink about 15 milliliters (mL) of water after taking the medicine.
- If you are giving this medicine through a gastrotomy or nasogastric tube: Place the oral syringe tip into the tube. Slowly push the plunger all the way down to give full dose. Flush the tube with 10 to 20 mL of water.
If you are unable to swallow the tablet whole:
- Wash your hands before and after preparing or taking this medicine.
- Put the tablet in a small cup with a teaspoon (5 mL) of room temperature non-chlorinated drinking water (including filtered water). Do not mix it with any liquids other than non-chlorinated drinking water.
- Gently swirl the cup until the tablet and water are fully mixed. It may take up to 3 minutes.
- Swallow the mixture right away. Add at least 15 mL of non-chlorinated drinking water into the cup to make sure there is no medicine left. Drink the mixture right away. Do not give the mixture via nasogastric or gastrotomy tube.
- Throw away mixture 10 minutes after mixing it.
Do not let the tablet or oral liquid touch your skin or eyes. If it gets on your skin, wash the area with soap and water. If it got in your eyes, rinse your eyes with water.
If the tablet mixture or oral liquid is spilled, use a dry paper towel to dry the area and clean it with soap and water.
Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
Missed dose: If you miss a dose and it is within 6 hours of your usual dose schedule, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is more than 6 hours of your usual dose schedule, skip the missed dose and take your next dose at the regular time.
Tablet: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Oral liquid:
- Store the oral liquid in the refrigerator. Do not freeze. If needed, you may store it at room temperature for a combined total of 5 days. You may put it back in the refrigerator. Throw away the oral liquid if it has been kept at room temperature for more than 5 days.
- Throw away any unused oral liquid 64 days after mixing it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Some medicines can affect how risdiplam works. Tell your doctor if you are using metformin.

Warnings While Using This Medicine:

It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 1 month after the last dose.
Tell your doctor if you are breastfeeding, or if you have liver disease.
Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Chest pain, trouble breathing
Fever, chills, cough, runny or stuffy nose, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

Diarrhea, constipation, vomiting
Mouth sores or ulcers

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 5/4/2025