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 for presymptomatic infants is consistent with the safety profile for symptomatic spinal muscular atrophy (SMA) patients treated with Evrysdi in clinical studies
No one in the clinical studies permanently stopped taking Evrysdi because of side effects of treatment.*
These are not all of the possible side effects of Evrysdi.
For more information on the risk and benefit profile of Evrysdi, ask your healthcare provider or pharmacist.
Ongoing studies are exploring the safety of Evrysdi in individuals who previously received a different SMA treatment.
*As of March 2024.
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.
Dive into more information about Evrysdi
Tips for starting treatment
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Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.
Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.
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Atrophy
The medical term for getting smaller, which is generally what happens to muscles when they are not stimulated by nerve cells.
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BSID-III
Stands for the Bayley Scales of Infant and Toddler Development–Third Edition, which is a tool used to assess a range of physical abilities, such as sitting, rolling, and crawling.
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CI
Stands for confidence interval, which shows how much a clinical result is likely to vary.
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DMT
Stands for disease-modifying treatment, which in the case of SMA, stimulates production of SMN2 protein.
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FDA
Stands for Food and Drug Administration.
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G-tube
Stands for gastrostomy tube, which is a tube inserted through the belly that brings nutrition directly to the stomach.
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Gene
The basic unit of heredity passed from parent to child, made up of sequences of DNA (deoxyribonucleic acid). They contain information that leads to the development of physical traits such as hair color.
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GI system
Stands for gastrointestinal system, also called the digestive system, which refers to the group of organs that take in food and liquids and break them down into energy the body can use.
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HINE-2
Stands for Hammersmith Infant Neurological Examination–Module 2, which is a tool used to assess 8 developmental milestones for infants, including head control, sitting, voluntary grasp, ability to kick, rolling, crawling, standing, and walking.
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Investigational
Term used to describe medical treatments that are currently being studied in clinical trials to determine how well they work and how safe they are to take.
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Larynx
Also known as the voice box, is a hollow tube in the middle of the neck, above the windpipe and esophagus. The larynx allows you to breathe and make sounds.
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MFM-32
Stands for Motor Function Measure-32 Items, which is a tool designed to capture changes in head, trunk, and limb motor movements using 32 elements in a broad range of people, including those who cannot walk. It uses 3 main categories: standing/transfer movements, upper/lower body movements, and hand/foot movements.
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Molecule
The smallest particle of a substance, made up of one or more atoms.
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NG-tube
Stands for nasogastric tube, which is a thin, soft tube that goes in through the nose, down the throat, and into the stomach to provide nutrition or medicine to those who cannot consume by mouth.
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Non-invasive
Term used to describe medicines or medical procedures that do not require inserting anything (such as a needle) through the skin or into a body opening.
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Oral
Refers to anything having to do with the mouth.
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PAL
Stands for Partnership and Access Liaison.
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Presymptomatic
When someone has not yet displayed any symptoms but may have underlying presence of the disease, as shown through testing or other means.
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Previously treated
When someone has taken either an approved or investigational medication specifically for SMA in the past.
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Progression
When the symptoms of SMA get worse over time.
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Progressive disease
Any condition that gets worse over time instead of improving.
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Protein
Large, complex molecules that play many important roles in the body, including making up the structure of cells and ensuring proper function of tissues and organs.
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RULM
Stands for Revised Upper Limb Module, which is a tool specifically designed for people 2.5 years and older living with SMA to evaluate strength in arm movements and the ability to perform certain tasks. It includes tests, such as picking up objects, like coins/tokens, tearing paper, raising a cup to the mouth, and opening a plastic container.
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Scoliosis
A sideways curve of the spine. Instead of appearing straight, the spine of a person with scoliosis will have an abnormal S or C shape that leads to their hips or shoulders appearing uneven.
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Sedation
A state of calmness, relaxation, or sleepiness as a result of medications called sedatives. Sedation can be used to help you relax or fall asleep for a medical procedure.
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SMA
Stands for spinal muscular atrophy, which is a genetic disease affecting the central nervous system, peripheral nervous system, and voluntary muscle movement.
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SMN
Stands for survival motor neuron, which is a type of protein that your muscles need to function.
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Spinal cord
A tube of tissue that runs from your brain down to your lower back and acts as an important part of your nervous system. The spinal cord carries nerve signals from your brain to the rest of your body, which allow you to feel sensations such as pressure or pain.
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Type 1 SMA
SMA symptoms that are present at 6 months of age or earlier. This is sometimes called “infantile onset.” Type 1 SMA is characterized by generalized muscle weakness, a weak cry, and muscle distress, often accompanied by failure to meet developmental milestones such as sitting up unassisted.
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Type 2 SMA
SMA symptoms that appear between the ages of 6 to 18 months. People with Type 2 SMA cannot stand or walk without help, but they can sit without support.
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Type 3 SMA
SMA symptoms that appear after 18 months of age. People with Type 3 SMA can walk independently but may have difficulty doing so or performing other movements such as running, rising from a chair, or climbing stairs.