How We Can Help


You’ve got this.
We’ll make sure of it.

Starting a therapy like VYONDYS 53 can be a hopeful but complex time in your family’s life. We’re committed to ensuring that you know what to expect and have assistance at every step of the process. That’s why we developed SareptAssist, our comprehensive patient support program, designed to provide you with information to help you navigate starting and staying on VYONDYS 53.

Meet Luke, age 12
Amenable to exon 53 skipping

Getting started with SareptAssist.

With your consent and signature, your doctor completes and sends in the SareptAssist Enrollment form. This form authorizes your Case Manager to start a benefits investigation of your current insurance coverage. Download the form to get the ball rolling.

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.

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Questions? 
Just give us a call at 1-888-SAREPTA (888-727-3782).
Case Managers are available Monday – Friday
8:30 am – 6:30 pm ET.

Here’s how SareptAssist can help:

One-on-one support from a dedicated Case Manager.

Once you enroll with SareptAssist, you’ll be connected to a dedicated Case Manager with experience in rare diseases, including knowledge of insurance plans and healthcare networks. 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, coordination of drug delivery, and access. Spanish-speaking Case Managers and interpreters for other languages are available.

Help navigate your insurance benefits.

Your Case Manager will help you understand how your insurance benefits work and can assist with the appeals process if your initial claim is denied. They can also provide information on options for financial assistance that you may qualify for.

Assistance with treatment locations.

You may receive VYONDYS 53 infusions at your doctor’s office, an infusion center, or at home. Your Case Manager will help by providing information on locations; discuss these options with your doctor to decide what’s best for your family.

Coordinating delivery of VYONDYS 53.

Once your insurance benefits are confirmed, SareptAssist will work with the providing specialty or hospital pharmacy to coordinate treatment access and drug delivery to your treatment location. 

Support for the long run.

You can count on SareptAssist support throughout your treatment journey. Whether you are changing insurance companies, appealing a denial of coverage, or planning a well-deserved vacation, we’ll work with you to ensure that your treatment continues uninterrupted. 

Information on financial assistance programs.

Your SareptAssist Case Manager can also provide information on financial support options you may qualify for, including the Co-Pay Assistance Program, Patient Assistance Program, and other support programs designed to assist with access to treatment.

Meet Luke, age 12

Meet the SareptAssist Team.

Watch this video to learn more about the one-on-one personalized support offered to you by SareptAssist.

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Questions about SareptAssist?

We are here to help.

Just give us a call at 1-888-SAREPTA (888-727-3782). Case Managers are available Monday – Friday 8:30 am – 6:30 pm ET.
 

Spanish-speaking Case Managers and interpreters for other languages are available.

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.

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“Our SareptAssist Case Manager is a friendly, helpful, and knowledgeable resource.”

-Ed, Luke’s father

Meet Ed, Luke's father

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.

Will my insurance cover VYONDYS 53?

Once your child is prescribed VYONDYS 53, you may enroll in SareptAssist, our patient support program. Your Case Manager will start a benefits investigation of your current insurance plan and can help explain details about your coverage. How SareptAssist can help.

See All FAQs

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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).