Starting Treatment

Getting started on treatment.

Now that you and your doctor have decided on treatment with EXONDYS 51, you probably have questions about what comes next. We’ll guide you along the way so you’ll know just what to expect.
 

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  1. Investigating Your Coverage

    Find out how SareptAssist, our patient support program, can help you get answers to questions about insurance benefits and verify coverage with your insurance company. Learn More

  1. Planning for Treatment

    Learn about creating a treatment plan that works for your family to help make the process go as smoothly as possible. Learn More

  1. About the Infusion

    Let’s take the mystery out of infusions. Here’s an overview of what they’re like, from start to finish. Learn More

  1. Ongoing Support

    It’s important to get ongoing support throughout treatment. SareptAssist will connect you with a dedicated Case Manager to help you start and stay on treatment. Learn More

Ongoing support and information from Sarepta.

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WHAT IS EXONDYS 51 (eteplirsen)?

EXONDYS 51 is used to treat patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the dystrophin gene that can be treated by skipping exon 51.

EXONDYS 51 was approved under accelerated approval. Accelerated approval allows for drugs to be approved based on a marker that is considered reasonably likely to predict a clinical benefit. EXONDYS 51 treatment increased the marker, dystrophin, in skeletal muscle in some patients. Verification of a clinical benefit may be needed for EXONDYS 51 to continue to be approved.

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IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions: Allergic reactions, including wheezing, chest pain, cough, rapid heart rate, and hives have occurred in patients who were treated with EXONDYS 51. Seek immediate medical care if signs and symptoms of allergic reactions occur.

Adverse Reactions: Side effects that have occurred at least 25% more often in patients treated with EXONDYS 51 than in patients treated with an inactive intravenous (IV) infusion were problems with balance (38%, 0%), vomiting (38%, 0%), and skin irritation (25%, 0%). The most common side effects were problems with balance and vomiting.

The most common side effects that occurred in greater than 10% of patients receiving EXONDYS 51 in other clinical trials were headache, cough, rash, and vomiting.

What do I do if I have side effects? 

Ask your healthcare provider for advice about any side effects that concern you.

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).

The information provided here does not include all that is known about EXONDYS 51. To learn more, talk with your healthcare provider.

Before receiving this infusion, please see the full Prescribing Information for EXONDYS 51 (eteplirsen).