Prescription medicine
Delandistrogene moxeparvovec-rokl Brand names: Elevidys
Delandistrogene moxeparvovec-rokl (Elevidys) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the delandistrogene moxeparvovec-rokl FDA label on DailyMed (effective August 12, 2026); every delandistrogene moxeparvovec-rokl label on DailyMed.
Highlights of the record
FDA label of August 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ACUTE SERIOUS LIVER INJURY AND ACUTE LIVER FAILURE.
Acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred with ELEVIDYS [see Warnings and Precautions ( 5.1 )]. Patients with preexisting liver impairment may be at higher risk [see Warnings and Precautions ( 5.1 )]. Prior to infusion, assess liver function by clinical examination and laboratory testing. Administer systemic corticosteroids before and after ELEVIDYS infusion. Continue to monitor liver function weekly for the first 3 months after infusion and continue until results are unremarkable [see Dosage and Administration (2.1, 2.2, 2.4)]. Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by the healthcare provider, for at least 2 months following ELEVIDYS infusion [see Dosage and Administration ( 2.1 )]. Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acute serious liver injury or impending acute liver failure is suspected [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )]. WARNING: ACUTE SERIOUS LIVER INJURY AND ACUTE LIVER FAILURE See full prescribing information for complete boxed warning. Acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred with ELEVIDYS. […]
Used for
From the label: indications and usageELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology ( 12.2 ), Clinical Studies ( 14 )].
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 342 through July 30, 2026
What is delandistrogene moxeparvovec-rokl used for?
From the label: indications and usageELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology ( 12.2 ), Clinical Studies ( 14 )]. ELEVIDYS is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD) who are ambulatory and have a confirmed mutation in the DMD gene. […]
Source: FDA drug label (ELEVIDYS), Sarepta Therapeutics, Inc., effective August 12, 2026 (SPL set 3525abcd-fbd2-46c5-9706-cffdf2e8a361), via openFDA; the full label on DailyMed
What does the patient leaflet for delandistrogene moxeparvovec-rokl say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information that you/your child should know about ELEVIDYS?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. Complication of blood clots in the blood vessel in the abdomen that helps carry blood from the intestines to the liver has happened. Patients with preexisting liver problems may be at higher risk. You/your child 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 your/your child's doctor recommends. Contact your/your child's doctor immediately if your/your child's skin and/or whites of the eyes appear yellowish or if your/your child misses a dose of corticosteroid or vomits it up. Serious Infection. Because you/your child will be taking corticosteroids as part of ELEVIDYS treatment, this may lower the ability of your/your child's 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 your/your child's doctor right away if you notice any signs of infection such as: coughing wheezing sneezing runny nose sore throat 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 if you have/your child has an infection. Inflammation of the heart muscle (Myocarditis). Serious and life-threatening inflammation of the heart muscle has happened following ELEVIDYS infusion. […]
From the patient leaflet: What should you/your child avoid after receiving ELEVIDYS?Avoid taking new medications that are known to damage the liver as this may make liver problems worse. Tell your doctor about all the medicines you/your child takes, including prescription and over-the counter medicines, vitamins, and herbal supplements. Discuss with your/your child's doctor before receiving a vaccine after ELEVIDYS treatment. Avoid missing any dose of corticosteroids. Contact your/your child's doctor immediately if this happens. See “ What is the most important information I should know about ELEVIDYS? ”
Source: FDA drug label (ELEVIDYS), Sarepta Therapeutics, Inc., effective August 12, 2026 (SPL set 3525abcd-fbd2-46c5-9706-cffdf2e8a361), via openFDA; the full label on DailyMed
Is there a generic for delandistrogene moxeparvovec-rokl (Elevidys)?
No generic delandistrogene moxeparvovec-rokl is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for delandistrogene moxeparvovec-rokl?
The FDA Adverse Event Reporting System holds 342 reports that list delandistrogene moxeparvovec-rokl among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 160 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Delandistrogene moxeparvovec-rokl side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other