Viltolarsen

Generic name: Viltolarsen
Brand names: Viltepso
Dosage form: intravenous solution (50 mg/mL)
Drug class: Miscellaneous uncategorized agents

Usage of 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 viltolarsen, but further studies are needed.

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

Viltolarsen side effects

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.

Viltolarsen may cause serious side effects. 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 of viltolarsen 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.

    Before taking Viltolarsen

    Tell your doctor if you have ever had kidney problems.

    Tell your doctor if you are pregnant or breastfeeding.

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    How to use Viltolarsen

    Usual Adult Dose for Muscular Dystrophy:

    80 mg/kg via IV infusion once a weekComments:-This drug has been approved under an accelerated approval process based on demonstrated increased dystrophin production in skeletal muscle observed in treated patients; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.Use: For the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

    Usual Pediatric Dose for Muscular Dystrophy:

    80 mg/kg via IV infusion once a weekComments:-This drug has been approved under an accelerated approval process based on demonstrated increased dystrophin production in skeletal muscle observed in treated patients; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.Use: For the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

    Warnings

    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 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.

    Disclaimer

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