INDICATIONS AND USAGE（适应症）

VILTEPSO is indicated 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. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

DOSAGE（服用剂量）

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.

ADVERSE REACTIONS（不良反应）

Upper respiratory tract infection

Injection site reaction

Cough

Pyrexia

Contusion

Arthralgia

Diarrhea

Vomiting

Abdominal pain

Ejection fraction decreased

Urticaria

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123/spl-doc?hl=viltolarsen

viltolarseninformation