Generic drug: viltolarsen

Brand name: Viltepso

What is Viltepso (viltolarsen), and how does it work?

Viltepso (viltolarsen) is an antisense oligonucleotide used to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

What are the side effects of Viltepso?

Side effects of Viltepso include:

Kidney Toxicity

Inform patients nephrotoxicity has occurred with drugs similar to Viltepso. Advise patients of the importance of monitoring for kidney toxicity by their healthcare providers during treatment with Viltepso.

What is the dosage for Viltepso?

Monitoring To Assess Safety

  • Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting Viltepso.
  • Consider measurement of glomerular filtration rate prior to initiation of Viltepso. Monitoring for kidney toxicity during treatment is recommended.
  • Obtain the urine samples prior to infusion of Viltepso or at least 48 hours after the most recent infusion.

Dosing Information

  • The recommended dosage of Viltepso is 80 mg/kg administered once weekly as a 60-minute intravenous infusion.
  • If a dose of Viltepso is missed, it should be administered as soon as possible after the scheduled dose time.

What drugs interact with Viltepso?

No information provided

Is Viltepso safe to use while pregnant or breastfeeding?

  • There are no human or animal data available to assess the use of Viltepso during pregnancy.
  • There are no human or animal data to assess the effect of Viltepso on milk production, the presence of viltolarsen in milk, or the effects of Viltepso on the breastfed infant.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Viltepso and any potential adverse effects on the breastfed infant from Viltepso or from the underlying maternal condition.

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Summary

Viltepso (viltolarsen) is an antisense oligonucleotide used to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. Nephrotoxicity has occurred with drugs similar to Viltepso. Side effects include upper respiratory tract infection, injection site reactions (bruising, redness, swelling), cough, fever, bruising, joint pain, diarrhea, vomiting, abdominal pain, ejection fraction decreased, and hives.

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Medically Reviewed on 3/29/2021
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All sections courtesy of the U.S. Food and Drug Administration