Risdiplam (ris-DIP-lam)

Treats spinal muscular atrophy (progressive muscle wasting).

Brand Name(s):

Evrysdi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Measure the liquid medicine with the oral syringe and take it within 5 minutes. Throw away any unused medicine after 5 minutes. Do not save leftover medicine.
• Take the medicine after a meal at about the same time each day. Drink a glass of water after taking the liquid to make sure it has been swallowed completely.
• Infants: Give this medicine after breastfeeding. Do not mix it with milk or formula.
• If you or your child cannot swallow the medicine, you may take it using a nasogastric or gastrotomy tube. Flush the tube with water after to make sure you get all of the medicine.
• 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.
• Store the liquid medicine in the refrigerator. Do not freeze. Throw away any unused medicine 64 days after it was mixed.

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