• Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children.

See the detailed Instructions for Use that comes with your prescription for information on how to take or give Evrysdi oral solution.

• You should receive Evrysdi from the pharmacy as a liquid that can be given by mouth or through a feeding tube.
• The liquid solution is prepared by your pharmacist. If the medicine in the bottle is a powder, do not use it. Contact your pharmacist for a replacement.
• Avoid getting Evrysdi on your skin or in your eyes. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water.

Taking Evrysdi

• Your healthcare provider will tell you how long you or your child needs to take Evrysdi. Do not stop treatment unless your healthcare provider tells you to.
• For infants and children, your healthcare provider will determine the daily dose of Evrysdi needed based on your child’s age and weight. For adults, take 5 mg of Evrysdi daily.
  • Take Evrysdi exactly as your healthcare provider tells you to take it. Do not change the dose without talking to your healthcare provider.
• Take Evrysdi 1 time daily after a meal (or after breastfeeding for a child) at approximately the same time each day. Drink water afterwards to make sure Evrysdi has been completely swallowed.
• Do not mix Evrysdi with formula or milk.
• If you are unable to swallow and have a nasogastric or gastrostomy tube, Evrysdi can be given through the tube.
• If you miss a dose of Evrysdi:
  • If you remember the missed dose within 6 hours of when you normally take Evrysdi, then take or give the dose. Continue taking Evrysdi at your usual time the next day.
  • If you remember the missed dose more than 6 hours after you normally take Evrysdi, skip the missed dose. Take your next dose at your usual time the next day.
• If you do not fully swallow the dose, or you vomit after taking a dose, do not take another dose to make up for that dose. Wait until the next day to take the next dose at your usual time.

Reusable Oral Syringes

• Your pharmacist will provide you with the reusable oral syringes that are needed for taking your medicine and explain how to use them. Wash the syringes per instructions after use. Do not throw them away.
• Use the reusable oral syringes provided by your pharmacist (you should receive 2 identical oral syringes) to measure your or your child’s dose of Evrysdi, as they are designed to protect the medicine from light. Contact your healthcare provider or pharmacist if your oral syringes are lost or damaged.
• Once transferred from the bottle to the oral syringe, take Evrysdi right away. Do not store the solution in the syringe. If Evrysdi is not taken within 5 minutes of when it is drawn up, Evrysdi should be thrown away from the reusable oral syringe, and a new dose should be prepared.

Before taking Evrysdi, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems.
• are pregnant or plan to become pregnant. If you are pregnant, or are planning to become pregnant, ask your healthcare provider for advice before taking this medicine. Evrysdi may harm your unborn baby.
• are a woman who can become pregnant:
  • Before you start your treatment with Evrysdi, your healthcare provider may test you for pregnancy. Because Evrysdi may harm your unborn baby, you and your healthcare provider will decide if taking Evrysdi is right for you during this time.
  • Talk to your healthcare provider about birth control methods that may be right for you. Use birth control while on treatment and for at least 1 month after stopping.
• are an adult male planning to have children: Evrysdi may affect a man’s ability to have children (fertility). If this is of concern to you, make sure to ask a healthcare provider for advice.
• are breastfeeding or plan to breastfeed. It is not known if Evrysdi passes into breast milk and may harm your baby. If you plan to breastfeed, discuss with your healthcare provider about the best way to feed your baby while on treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

The most common side effects include:

• For later-onset SMA:
  • fever
  • diarrhea
  • rash
• For infantile-onset SMA:
  • fever
  • runny nose, sneezing, sore throat, and cough (upper respiratory infection)
  • constipation
  • diarrhea
  • lung infection
  • vomiting
  • rash

These are not all of the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.