Viltepso 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.

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

Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Tell your doctor if you have ever had kidney problems.

Tell your doctor if you are pregnant or breastfeeding.

 How is Viltepso given?

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

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

Viltepso 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.

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

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

Viltepso 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.

Tell your doctor if you have ever had kidney problems.

Tell your doctor if you are pregnant or breastfeeding.

Call your doctor for instructions if you miss an appointment for your treatment.

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

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 signs of kidney problems including:

• the inability to pass urine;
• a change in how much urine is passed;
• blood in the urine; or
• fluid retention, causing swelling in your legs, ankles or feet.

Common side effects may include:

• runny or stuffy nose;
• cough;
• fever;
• bruising or swelling at the injection site;
• joint pain;
• diarrhea;
• vomiting;
• stomach pain;
• fatigue;
• shortness of breath; and
• rash.

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.

Other drugs may affect Viltepso, 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.