Sarepta Therapeutics Provides Clinical Updates for ELEVIDYS

Date: November 25, 2025

Attention: Providers

Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers that the Health and Human Services Commission (HHSC) has been made aware of several key updates for the drug:

• A boxed warning for the risk of acute serious liver injury and acute liver failure
• Removal of the non-ambulatory indication from the “Indication and Usage” section of the Prescribing Information
• Expanded guidance for prescribers, including a modified pre- and post-infusion oral corticosteroids regimen, and enhanced monitoring recommendations every week for 3 months post-infusion
• A new Warnings & Precaution regarding increased susceptibility to serious infections due to immunosuppression

Background: ELEVIDYS (Delandistrogene moxeparvovec-rokl) (HCPCS code J1413) is an adeno-associated virus vector-based gene therapy indicated for the treatment of individuals aged four years or older with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene.

Previously posted TCHP communication on this important topic is available by clicking here.

Next step for Providers: Providers should follow the guidance found in this communication and the following link elevidys.com/pi for prescribing information.

If you have any questions, please email Provider Relations at providerrelations@texaschildrens.org. 

For access to all provider alerts: www.texaschildrenshealthplan.org/provideralerts.