Risdiplam Solution

What is this medication?

RISDIPLAM (ris DIP lam) treats spinal muscular atrophy (SMA), a condition that causes muscle loss and weakness. It works by helping your body make more of a protein needed to support muscle function. This delays worsening symptoms.

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Use the provided oral syringe to measure each dose. Take the dose within 5 minutes of pulling it into the syringe. You can take it with or without food. If it upsets your stomach, take it with food. It can be taken before or after breastfeeding. Do not mix the medication with formula or milk. Drink water after you have taken the medication. This ensures the entire dose has been swallowed. Keep taking this medication unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Wash your hands before and after taking or preparing the medication. Do not get it 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 care team about the use of this medication 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, take it as soon as you can, unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose. Take the next dose at the normal time. Do not take double or extra doses.

If the dose is not fully swallowed or you vomit after taking your dose, do not take another dose. Take your next dose at your usual time the next day.

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

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 month after the last dose. Your care team can help you find the option that works for you.

This medication may cause infertility. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

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

• Constipation
• Cough
• Diarrhea
• Fever
• Skin rash
• 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 and pets.

Store in a refrigerator or at room temperature up to 40 degrees C (104 degrees F).

Refrigeration (preferred): Store in the refrigerator. Do not freeze. Keep this medication in the original container. Protect from light. Get rid of any unused medication after 64 days.

Room Temperature: This medication may be stored at room temperature for a combined total of 5 days. It can be removed from and returned to a refrigerator. Keep this medication in the original container. Protect from light. Get rid of any unused medication after a combined total of 5 days at room temperature or 64 days since being mixed by the pharmacist, whichever occurs first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.