Established safety profile in adults, children, and infants with SMA

Established safety profile in adults, children, and infants with SMA

Patients living with SMA

The most common side effects of Evrysdi include:

IN ADULTS AND CHILDREN

Type 2 or 3 SMA (later-onset)

  • fever
  • diarrhea
  • rash

IN INFANTS

Type 1 SMA (infantile-onset)

  • fever
  • diarrhea
  • rash
  • runny nose, sneezing, sore throat, and cough (upper respiratory infection)
  • lung infection
  • constipation
  • vomiting


These are not all of the possible side effects of Evrysdi. For more information on the possible risks and benefits of Evrysdi, speak to your healthcare provider.

 

No one in the later-onset or infantile-onset clinical studies stopped taking Evrysdi because of side effects after 24 months of treatment

No one in the later-onset or infantile-onset clinical studies stopped taking Evrysdi because of side effects after 24 months of treatment


Safety in people with previously treated SMA (JEWELFISH trial)

Initial safety findings from people who previously took other approved or investigational SMA medications have been consistent with the safety findings from studies in adults, children, and infants who only took Evrysdi.

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Learn more about Evrysdi

What is Evrysdi?

Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.

It is not known if Evrysdi is safe and effective in children under 2 months of age.

  • Before taking Evrysdi, tell your healthcare provider about all of your medical conditions, including if you
    • are pregnant or plan to become pregnant, as Evrysdi may harm your unborn baby. Ask your healthcare provider for advice before taking this medicine
    • are a woman who can become pregnant:
      • Before you start your treatment with Evrysdi, your healthcare provider may test you for pregnancy
      • 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 Evrysdi
    • are an adult male. Evrysdi may affect a man’s ability to have children (fertility). Ask a healthcare provider for advice before taking this medicine
    • are breastfeeding or plan to breastfeed. It is not known if Evrysdi passes into breast milk and may harm your baby
  • Tell your healthcare provider about all the medicines you take
  • You should receive Evrysdi from the pharmacy as a liquid. 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
  • The most common side effects of Evrysdi include:
    • For later-onset SMA:
      • fever
      • diarrhea
      • rash
    • For infantile-onset SMA:            
      • fever
      • diarrhea
      • rash
      • runny nose, sneezing, sore throat, and cough (upper respiratory infection)
      • lung infection
      • constipation
      • vomiting

These are not all of the possible side effects of Evrysdi. For more information on the risk and benefits profile of Evrysdi, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

    • Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.

      Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.