GET YOUR PATIENT STARTED IN JUST 3 EASY STEPS:
With your patient, fill out the START Form and fax it to 1-800-621-5203.
A dedicated SareptAssist Case Manager will contact your patient to welcome them to the program and explain how they can help.
Ready to begin prescribing EXONDYS 51? Here’s what you need to know.
This guide provides recommended dosing guidelines, along with important safety information, storage instructions, and information on preparing and infusing EXONDYS 51.
Find important billing and coding information at a glance, plus supporting documents to submit when your patient’s health plan requires prior authorization.
Here’s what you need to enroll your patient in SareptAssist, plus additional resources designed to assist you in getting your patient started on EXONDYS 51.
With your patient’s consent and signature, complete this form to enroll them in SareptAssist, our patient support program.
This form authorizes a Case Manager to start a benefits investigation to help with insurance benefits. Fax the completed form with the patient’s Genetic Mutation Worksheet to 1-800-621-5203.
This worksheet will help you determine whether your patient is appropriate for EXONDYS 51 therapy. Fax the completed form with the patient’s START Form to 1-800-621-5203.
QUESTIONS? LET SAREPTASSIST HELP.
Give us a call. 1-888-SAREPTA (1-888-727-3782)
Case Managers are available Monday – Friday 8:30am – 6:30pm ET.
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INDICATION
EXONDYS 51 (eteplirsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions, including bronchospasm, chest pain, cough, tachycardia and urticaria, have occurred in patients who were treated with EXONDYS 51. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting the EXONDYS 51 therapy.
Adverse reactions in DMD patients (N=8) treated with EXONDYS 51 30 or 50 mg/kg/week by intravenous (IV) infusion with an incidence of at least 25% more than placebo (N=4) (Study 1, 24 weeks) were (EXONDYS 51, placebo): balance disorder (38%, 0%), vomiting (38%, 0%) and contact dermatitis (25%, 0%). The most common adverse reactions were balance disorder and vomiting. Because of the small numbers of patients, these represent crude frequencies that may not reflect the frequencies observed in practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is not recommended.
The most common adverse reactions from observational clinical studies (N=163) seen in greater than 10% of patients were headache, cough, rash, and vomiting.
Please see the full Prescribing Information for EXONDYS 51 (eteplirsen).