US Healthcare Professionals

Extensively studied, with consistent safety profile across all approved doses

Extensively studied, with consistent safety profile across all approved doses

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, and sore throat (upper respiratory infection)
  • lung infection (lower respiratory infection)
  • constipation
  • vomiting
  • cough


The safety profile of Evrysdi in infants treated before symptoms of SMA appear (presymptomatic) was consistent with the safety profile of Evrysdi in infants with Type 1 SMA and adults and children with Type 2 or 3 SMA.

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 clinical studies permanently stopped taking Evrysdi because of side effects of treatment*

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.

*As of March 2022.

No required monitoring or laboratory testing needed
No required monitoring or laboratory testing needed

 

Tips to help with common side effects

As always, your doctor is the best resource for any questions. It’s important to talk to your doctor if you notice any changes, begin any new medication, or make changes in your overall care. Below are some tips that may help if you experience these changes.

If you experience diarrhea:

  • It means you have loose, watery, and more-frequent bowel movements
  • Some dietary tips you can consider include:
    • Drinking more fluids, such as water, broths, and juices
    • Avoiding juices or foods that have a laxative effect, such as prunes​ or prune juice
    • Eating semisolid and low-fiber food gradually, such as soda crackers, toast, eggs, rice, or chicken
    • Avoiding dairy products, fatty foods, high-fiber foods, or highly seasoned foods for a few days
  • In Evrysdi clinical studies, 17% of adults and children taking Evrysdi experienced diarrhea, with a similar frequency in infants. The majority of cases† (8 out of 10) lasted less than 1 week; about 1 out of 10 cases lasted longer than 2 weeks
  • Talk to your healthcare provider if you are taking any prescription medications (such as statins), over-the-counter medications (such as stool softeners), vitamins, dietary supplements, or additional fiber that may impact bowel movements.

 

If you experience rash:

  • It means you have an area of irritated or swollen skin; it may be itchy and red  
  • Some tips you can consider include:
    • Using moisturizer or lotions
    • Taking a cool bath
    • Avoiding harsh soaps
    • Using cortisone cream to relieve swelling (if not infected)
    • Avoiding wearing tight clothing

†Cases with a known duration.

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Important Safety Information and Indication

What is Evrysdi?

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

  • 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
      • Pregnancy Registry. There is a pregnancy registry for women who take Evrysdi during pregnancy. The purpose of this registry is to collect information about the health of the pregnant woman and her baby. If you are pregnant or become pregnant while receiving Evrysdi, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Evrysdi Pregnancy Registry. Your healthcare provider can enroll you in this registry or you can enroll by calling 1-833-760-1098 or visiting www.evrysdipregnancyregistry.com
    • 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, and sore throat (upper respiratory infection)
      • lung infection (lower respiratory infection)
      • constipation
      • vomiting
      • cough

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.