The Road to ELEVIDYS Infusion Day

The FDA-approved Sarepta’s gene therapy treatment, ELEVIDYS, is for children and adults with Duchenne muscular dystrophy. Before the patient's ELEVIDYS infusion, there are three steps to complete.

First, the patient must have documentation that proves they are an appropriate candidate for the treatment. Next, the treatment must be approved by the patient’s insurance company. Finally, the patient will start taking a high-dose steroid to prepare for the infusion.

Your Gillette provider will help document the patient’s medical eligibility for ELEVIDYS by confirming:

Your Gillette care team will send prior authorization (PA) to the patient’s insurance company.

Please Note:

In some cases, the prior authorization (PA) request may be denied by the patient’s insurance company. If this is the case, your Gillette care team will help you appeal this decision. Please be aware that the denial and appeal process can be long and frustrating – taking up to several months in some cases. Rarely, an insurance company’s denial is upheld despite our best efforts, and we are unable to treat the patient.

After prior authorization is approved, your Gillette care team will work with you to schedule the patient’s ELEVIDYS infusion. The patient’s infusion date will be at least 14 days after prior authorization is approved to allow time for the medication to be prepared and shipped.

All patients are required to take a high-dose steroid, prednisone or prednisolone, before and after ELEVIDYS. Your provider will prescribe a specific dose based on the patient’s weight. Depending on the patient’s current use of steroids, they will begin a different steroid dose and/or type.

For Patients New to Steroids

If the patient is not currently on steroids, they will begin taking prednisone/prednisolone 7 days before their infusion day (the 8th dose of steroids) and will continue this high dose for a minimum of 60 days after infusion. Then the patient will wean off the high dose over a 2-week taper period.*

For Patients Already Taking Steroids

If the patient is already on steroids, he will begin a high dose of prednisone/prednisolone the day before his infusion day and will continue this high dose for a minimum of 60 days after infusion. Then the patient will wean off the high dose over a 2-week taper period.*

Other Medications

The patient will be prescribed a stomach protectant to take alongside the steroids. He will also be prescribed a nausea-control medication, ondansetron (Zofran) to take as needed after infusion.

*Some side effects will be treated with even higher doses of steroids and may require a slower taper and longer total duration of post-infusion steroids.

Please Note:

It is extremely important that the patient receives his daily dose of steroids. Contact your doctor if he misses even a single steroid dose or vomits it up.

Due to corticosteroid use, an infection (eg, cold, flu, stomach flu, ear infection, respiratory infection, etc.) before or after ELEVIDYS infusion could lead to more serious complications. Call your doctor immediately if you see symptoms suggestive of infection (eg, coughing, wheezing, sneezing, runny nose, sore throat, or fever).