Starting Treatment

Getting started on treatment.

Now that you and your doctor have decided to explore treatment with AMONDYS 45, you probably have questions about what comes next. We’ll guide you along the way so you’ll know just what to expect.

Let's START

Meet Levi, age 10. Amenable to exon 45 skipping

  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

     

  2. 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

     

  3. 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

     

  4. 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

Meet the SareptAssist Team.

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

SareptAssist is a resource available to those who have been prescribed one of Sarepta's approved products. SareptAssist is only available in the United States.

Ongoing support and information from Sarepta.

Sign Up
vial icon

Receive future tips and support about treatment with AMONDYS 45.

Icon Signup Informed

Stay informed about SareptAssist services.

An icon of 3 people and a circle

Find out about patient resources that are available.

envelope

Get updates about news and research on Duchenne from Sarepta.

Sign Up

Read More

 

What is AMONDYS 45 (casimersen)?

AMONDYS 45 is used to treat patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the dystrophin gene that can be treated by skipping exon 45.

This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.

Read More

IMPORTANT SAFETY INFORMATION

Contraindications: Do not receive AMONDYS 45 if you are allergic to casimersen or any of the ingredients in AMONDYS 45. Serious allergic reactions to casimersen have included anaphylaxis, which may include difficulty breathing, tightness in the chest, and angioedema which may include swelling of the mouth, face, lips, or tongue.

Hypersensitivity Reactions: Serious allergic reactions, including angioedema and anaphylaxis, have occurred in patients who were treated with AMONDYS 45. Patients should seek immediate medical care should they experience signs and symptoms of allergic reactions. Your doctor will institute appropriate medical treatment which may include slowing, interrupting, or discontinuing the AMONDYS 45 infusion. Your doctor will monitor you until the condition resolves.

Kidney Toxicity and Monitoring: Damage to the kidneys was seen in animals who received casimersen. Although damage to the kidneys was not seen in clinical studies with AMONDYS 45, 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 occurring in at least 20% of patients treated with AMONDYS 45 and at least 5% more frequently than in patients who received an inactive intravenous (IV) infusion were (AMONDYS 45, placebo): upper respiratory tract infection (65%, 55%), cough (33%, 26%), fever (33%, 23%), headache (32%, 19%), joint pain (21%, 10%), and pain in mouth and throat (21%, 7%).

Other side effects that occurred in at least 10% of patients treated with AMONDYS 45 and at least 5% more frequently than patients who received an inactive IV infusion were: ear pain, nausea, ear infection, pain after injury, and dizziness and light-headedness.

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 AMONDYS 45. To learn more, talk with your healthcare provider.

Before receiving this infusion, please see the full Prescribing Information for AMONDYS 45 (casimersen).