Evrysdi

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking risdiplam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Risdiplam should come as a liquid form prepared by the pharmacy. If it is a powder form, do not use it and contact your pharmacy right away.

Take this medication by mouth after a meal as directed by your doctor, usually once daily. The dosage is based on your age and body weight. For infants who breastfeed, this medication should be given after breastfeeding. Do not mix this medication with formula, milk, or any other food or liquid. Drink some water after taking this medication to make sure that the medication is completely swallowed.

For patients who cannot swallow and have a feeding tube, this medication can be given through the tube. The tube should be flushed with water after the medication is given.

Carefully measure the dose using the provided measuring syringe. Do not use a household spoon because you may not get the correct dose. Once the dose is drawn into the syringe, it must be taken right away. If it is not used within 5 minutes, the drug in the syringe should be thrown away and a new dose prepared with the syringe.

Avoid getting the medication on your skin or in your eyes. If you get the medication on your skin, wash with soap and water. If you get the medication in your eyes, rinse with plenty of water.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you vomit after taking a dose or did not take the full dose, do not take another dose at that time. Take your next dose at the regular time.

Tell your doctor if your condition does not get better or if it gets worse.

Diarrhea, constipation, mouth sores, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as sore throat that doesn't go away, fever, cough).

Risdiplam can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking risdiplam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using risdiplam. Risdiplam may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 1 month after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Do not share this medication with others.

If you miss a dose, take it as soon as you remember. If it is more than 6 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.