viltolarsen

What is the most important information I should know about viltolarsen?

Before using viltolarsen tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

What is viltolarsen?

Viltolarsen 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.

Viltolarsen 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.

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

What should I discuss with my healthcare provider before receiving viltolarsen?

Tell your doctor if you have ever had kidney problems.

Tell your doctor if you are pregnant or breastfeeding.

How is viltolarsen given?

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

Viltolarsen 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 about 60 minutes to complete.

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

Viltolarsen doses are based on weight. Your dose needs may change if you gain or lose weight.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving viltolarsen?

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

What are the possible side effects of viltolarsen?

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

Common side effects may include:

• redness, bruising, or swelling where an injection was given;
• fever;
• cough; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 other drugs will affect viltolarsen?

Other drugs may affect viltolarsen, 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?

Your pharmacist can provide more information about viltolarsen.