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golodirsen (Vyondys 53)

Brand Names: Vyondys 53

Generic Name: golodirsen

What is golodirsen (Vyondys 53)?

Golodirsen is used to treat Duchenne muscular dystrophy in adults and children who have a certain gene mutation. Your doctor will test you for this gene mutation.

Golodirsen was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Golodirsen may also be used for purposes not listed in this medication guide.

What are the possible side effects of golodirsen (Vyondys 53)?

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, blistering or peeling; fever; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pink, brown, or red urine;
  • foamy urine; or
  • swelling in your face, hands, feet, or stomach.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about golodirsen (Vyondys 53)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before receiving golodirsen (Vyondys 53)?

Tell your doctor if you have ever had kidney problems.

Tell your doctor if you are pregnant or breastfeeding.

How is golodirsen given (Vyondys 53)?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using golodirsen.

Golodirsen is given as an infusion into a vein, usually once per week. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take up to 60 minutes to complete.

Your kidney function may need to be checked while you are using this medicine.

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What happens if I miss a dose (Vyondys 53)?

Call your doctor for instructions if you miss an appointment for your golodirsen injection.

What happens if I overdose (Vyondys 53)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving golodirsen (Vyondys 53)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect golodirsen (Vyondys 53)?

Other drugs may affect golodirsen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information (Vyondys 53)?

Your pharmacist can provide more information about golodirsen.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Reviewed on 1/21/2021

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