Risdiplam oral solution

What is this medication?

RISDIPLAM (ris DIP lam) is used to treat patients with spinal muscular atrophy (SMA). It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Evrysdi

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to risdiplam, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Follow the directions on the prescription label. Use the provided oral syringe to measure each dose. Once the dose is pulled up into the oral syringe, take the dose within 5 minutes. If it is not taken within 5 minutes of drawing it up, throw away the dose and prepare a new dose. Take this medicine after a meal. Drink water after you have taken your medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. Do not get this medicine on your skin or in your eyes. If it gets on your skin, wash the area with soap and water. If it gets in your eyes, rinse your eyes with water.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose and it is within 6 hours of when you normally take it, take it as soon as you can. If it is more than 6 hours after you normally take the dose, skip the missed dose. Take your next dose at the normal time. Do not take double or extra doses.

What may interact with this medication?

• metformin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their health care professional if they wish to become pregnant or think they might be pregnant. There is potential for serious side effects to an unborn child. Talk to your health care professional for more information.

This medicine has caused decreased sperm counts in some men. This may make it more difficult to father a child. Talk to your health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives; swelling of the face, lips, or tongue

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• cough
• diarrhea
• fever
• mouth sores
• sore throat
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store this medicine in the refrigerator. Do not freeze. Keep this medicine in the original container. Throw away any unused medicine after 64 days.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.