Start right here—with help from SareptAssist.

Need some guidance as you navigate the complexities of starting treatment? We’re here to help with SareptAssist, our patient support program.

 

It’s easy to enroll: Once your doctor has prescribed VYONDYS 53, just print out the enrollment form and sign it to indicate your consent. Then, take it to your doctor to complete and send in the form for you. This authorizes SareptAssist to start working on your behalf.

Download Enrollment Form

SareptAssist is a resource available to those pursuing or currently utilizing one of Sarepta's approved products. SareptAssist is only available in the United States.

 

Questions?

Give us a call.
 


1-888-SAREPTA

1-888-727-3782
Case Managers are available Monday – Friday
8:30 am – 6:30 pm ET

 

Ashley, SareptAssist Case Manager



Did you know? While your doctor is your primary resource for discussing your medical needs, your Case Manager can be one of your key contacts for questions regarding insurance benefits, treatment coordination, and access.

 

What to expect after your enrollment form is submitted.

A welcome call.

Introducing you to SareptAssist.
 

call

When enrollment is complete, your dedicated Case Manager will call to welcome you to SareptAssist, explain how they can help, and answer your questions. With their experience in rare diseases, insurance plans, and healthcare networks, you’ll have Support, By Your Side.

Benefits investigation.

Ensuring you’re covered for 
VYONDYS 53.


Your Case Manager will help you understand your insurance benefits and contact your insurance company to verify coverage. Depending on your type of insurance and relevant circumstances, they can also provide information on other financial assistance options you may be eligible for.

Next: Start planning for treatment.
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“There are a lot of steps; families and patients have lots of questions. It’s my responsibility to really just explain the whole process.”

–Diane, SareptAssist Case Manager

Diane, SareptAssist case manager

Related FAQs

How can I connect with other families of children with Duchenne?

Several advocacy organizations offer Duchenne patients and families the opportunity to come together at events throughout the year. Find out more about Duchenne advocacy groups.

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WHAT IS VYONDYS 53 (golodirsen)?

VYONDYS 53 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 53.

This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Contraindications: Do not receive VYONDYS 53 if you are allergic to golodirsen or any of the ingredients in VYONDYS 53. Serious allergic reactions to golodirsen have included anaphylaxis, which may include difficulty breathing and tightness in the chest.

Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis, have occurred in patients who were treated with VYONDYS 53. Additional allergic reactions, including rash, fever, itching, hives, and inflammation and/or peeling of the skin have occurred in patients who were treated with VYONDYS 53. Patients should seek immediate medical care should they experience signs and symptoms of allergic reaction. Your doctor will institute appropriate medical treatment which may include slowing, interrupting, or discontinuing the VYONDYS 53 infusion. Your doctor will monitor you until the condition resolves.

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IMPORTANT SAFETY INFORMATION

Contraindications: Do not receive VYONDYS 53 if you are allergic to golodirsen or any of the ingredients in VYONDYS 53. Serious allergic reactions to golodirsen have included anaphylaxis, which may include difficulty breathing and tightness in the chest.

Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis, have occurred in patients who were treated with VYONDYS 53. Additional allergic reactions, including rash, fever, itching, hives, and inflammation and/or peeling of the skin have occurred in patients who were treated with VYONDYS 53. Patients should seek immediate medical care should they experience signs and symptoms of allergic reaction. Your doctor will institute appropriate medical treatment which may include slowing, interrupting, or discontinuing the VYONDYS 53 infusion. Your doctor will monitor you until the condition resolves.

 

Kidney Toxicity and Monitoring: Damage to the kidneys was seen in animals who received golodirsen. Although damage to the kidneys was not seen in clinical studies with VYONDYS 53, potentially fatal kidney damage has occurred with other drugs that work in a similar way. Your doctor may recommend urine and blood testing before starting treatment followed by urine testing every month and a blood test every 3 months to monitor your kidneys.

Adverse Reactions: Side effects that have occurred in at least 20% of patients treated with VYONDYS 53 and more often than in patients who received an inactive intravenous (IV) infusion were headache (41%, 10%), fever (41%, 14%), fall (29%, 19%), pain in the abdomen (27%, 10%), infection of the nose and throat (27%, 14%), cough (27%, 19%), vomiting (27%, 19%), and nausea (20%, 10%).

Other side effects that occurred in greater than 5% of patients treated with VYONDYS 53 and more often than in patients who received an inactive IV infusion were pain at the IV site, back pain, pain, diarrhea, dizziness, stretch or tear in a ligament, bruising, flu, pain in the mouth and throat, stuffy or runny nose, scrapes or scratches of the skin, ear infection, seasonal allergy, fast heartbeat, reactions related to the IV catheter site, constipation, and broken bones.

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 VYONDYS 53. To learn more, talk with your healthcare provider.

Before receiving this infusion, please see the full Prescribing Information for VYONDYS 53 (golodirsen).