About ELEVIDYS® (delandistrogene moxeparvovec-rokl)
Welcome to the official ELEVIDYS page. IMPORTANT SAFETY INFORMATION
Please see full Important Safety Information at ELEVIDYS.com/ISI, full Prescribing Information, including
Boxed Warning, at ELEVIDYS.com/PI, and the Medication Guide at ELEVIDYS.com/Med-Guide. RAPID SERIOUS LIVER INJURY AND RAPID LIVER FAILURE
• ELEVIDYS CAN INCREASE
CERTAIN LIVER LAB TEST LEVELS AND CAUSE RAPID SERIOUS LIVER
INJURY, RAPID LIVER FAILURE, AND DEATH. Patients with preexisting liver problems may be at higher
risk.
• Complication of blood clots in the blood vessel in the abdomen that helps carry blood from the intestines
to the liver has happened.
• Patients will receive oral corticosteroid medication before and after ELEVIDYS infusion and will need
weekly blood tests to monitor liver function for 3 months or longer after treatment.
• For at least 2 months following ELEVIDYS infusion, stay close to a healthcare facility that the doctor
recommends.
• Contact a doctor immediately if the patient’s skin and/or whites of the eyes appear yellowish or if the
patient misses a dose of corticosteroid or vomits it up. SERIOUS INFECTION
• Because patients will be taking corticosteroids as part of ELEVIDYS treatment, this may lower the ability
of their immune system to fight infections and make it easier to get an infection. Getting an infection
(like a cold, flu, stomach flu, ear infection, chest infection) before or after ELEVIDYS infusion could lead
to more serious health problems, including death.
• Contact a doctor right away if you notice any signs of infection, such as coughing, wheezing, sneezing,
runny nose, sore throat, or fever.
• Vaccinations should be completed at least 4 weeks before starting the corticosteroids that are part of
the ELEVIDYS treatment.
• ELEVIDYS should not be given to patients with an infection. INFLAMMATION OF THE HEART MUSCLE
• Serious and life-threatening inflammation of the heart muscle has happened following ELEVIDYS
infusion.
• Patients will need weekly blood tests for a heart protein that can detect damage to the heart muscle
cells for the first month after treatment.
• Contact a doctor right away if the patient begins to experience chest pain and/or trouble breathing or
shortness of breath. INFUSION-RELATED REACTIONS
• Infusion-related reactions, including hypersensitivity and serious allergic reactions (anaphylaxis), have
happened during and after ELEVIDYS infusion.
• Contact a doctor right away if you notice: fast heart rate, fast breathing, swollen lips, shortness of
breath, nostrils widening, hives, red and blotchy skin, itchy or inflamed lips, rash, vomiting, nausea,
chills, and fever.
• Your doctor will monitor you during and at least 3 hours after ELEVIDYS infusion. If an infusion-related
reaction occurs, your doctor may slow or stop the ELEVIDYS infusion and provide additional medical
treatment as needed. IMMUNE RESPONSE AFFECTING MUSCLES ( IMMUNE-MEDIATED MYOSITIS)
• Immune response affecting muscles, including serious and life-threatening reactions, has happened in
patients about 1 month after receiving ELEVIDYS infusion.
• Contact a doctor immediately if the patient experiences any unexplained increased muscle pain,
tenderness, or weakness, including trouble swallowing, breathing, or speaking. ANTIBODIES TO ELEVIDYS
• Patients need to have blood tests to ensure that they do not have antibodies that may prevent them from
being able to receive ELEVIDYS. High levels of antibodies may keep the medicine from working as
intended.
• Treatment with ELEVIDYS is not recommended for patients who have high antibodies to the vector, the
part of gene therapy used to deliver ELEVIDYS. YOU SHOULD DISCUSS THE POTENTIAL BENEFITS AND RISKS OF ELEVIDYS WITH YOUR DOCTOR. WHO SHOULD NOT RECEIVE ELEVIDYS? Individuals with a certain type of genetic mutation, called a deletion, involving any portion of or the entire
exon 8 and/or exon 9 in the DMD gene, should not receive ELEVIDYS. ARE THERE ANY CONSIDERATIONS FOR VACCINATION SCHEDULES AND ELEVIDYS? Patient vaccinations should be up to date with current immunization guidelines. Vaccinations should be
completed at least 4 weeks before starting corticosteroids that are part of the ELEVIDYS treatment. ARE THERE ANY PRECAUTIONS THAT NEED TO BE CONSIDERED WHEN HANDLING A PATIENT’S BODILY
WASTE? Vector shedding of ELEVIDYS occurs primarily through body waste. Patients and caregivers should use
proper hand hygiene, such as hand washing, when coming into direct contact with patient body waste. Place potentially contaminated materials that may have the patient’s bodily fluids/waste in a sealable bag
and dispose into regular trash. Precautions should be followed for 1 month after ELEVIDYS infusion. WHAT ARE THE MOST COMMON SIDE EFFECTS OF ELEVIDYS? The most common side effects that occurred in patients treated with ELEVIDYS were vomiting, nausea,
liver injury, fever, lower number of platelets (a kind of blood cell that helps you stop bleeding), and higher
levels of heart protein that can detect damage to muscle cells in the heart. The safety information provided here is not comprehensive. Talk to the patient’s doctor about any side
effects that bother the patient or that don’t go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics
at 1-888-SAREPTA (1-888-727-3782). WHAT IS ELEVIDYS? ELEVIDYS is a prescription gene therapy used to treat ambulatory individuals at least 4 years old with
Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene. ELEVIDYS is not recommended for individuals with:
• Preexisting liver problems or liver infection because of the high risk of rapid serious liver injury and rapid
liver failure
• Recent vaccination (within 4 weeks of ELEVIDYS treatment)
• Current or recent infections (within 4 weeks of ELEVIDYS treatment)
Please see full Prescribing Information, including Boxed Warning, at ELEVIDYS.com/PI and Medication
Guide at ELEVIDYS.com/Med-Guide.
