VILTOLARSEN

Other

Brand names: Viltepso

Intravenous

Mechanism of Action

12.1 Mechanism of Action VILTEPSO is designed to bind to exon 53 of dystrophin pre-mRNA resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 53 skipping. Exon 53 skipping is intended to allow for production of an internally truncated dystrophin protein in patients with genetic mutations that are amenable to exon 53 skipping.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Kidney Toxicity: Based on animal data, may cause kidney toxicity
Although kidney toxicity was not observed in the clinical studies with VILTEPSO, the clinical experience with VILTEPSO is limited, and kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides

Known Side Effects

9 documented side effects by frequency

Fever

>10%

Vomiting

1-10%

General Unwellness

1-10%

Weight Gain

1-10%

Cough

1-10%

Diarrhea

0.1-1%

Falls

0.1-1%

Nausea

0.1-1%

Upper Respiratory Infection

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous