250mg/5mL (50mg/mL) single-dose vial. Duchenne Muscular Dystrophy. Indicated for Duchenne muscular dystrophy (DMD) in patients with a confirmed DMD gene mutation that is amenable to exon 53 skipping. 80 mg/kg IV qWeek.

DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.

Paramus, NJ: NS Pharma; 2020. The Food and Drug Administration (FDA) has granted accelerated approval to Viltepso (viltolarsen; NS Pharma) for the treatment of Duchenne VILTEPSO is a drug for the treatment of a particular type of Duchenne muscular dystrophy (DMD). It is to be used only in patients who have a specific mutation of the dystrophin gene. About Viltepso Viltepso uses NS Pharma’s exon-skipping technology to target exon 53 of the DMD gene.

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Paramus, NJ: NS Pharma, Inc.; August 2020. APPROVAL HISTORY December 8, 2020: Reviewed by Pharmacy & Therapeutics Committee. Subsequent endorsement date(s) and changes made: 1. February 9, 2021: No changes.

Viltepso while maintaining optimal therapeutic outcomes. References Viltepso [Package Insert]. Paramus, NJ: NS Pharma, Inc.; August 2020. Policy History Date Action September 2020 Addition to PA December 2020 Annual review. Per FEP, addition of requirement of no concurrent therapy with another exon skipping therapy for DMD Keywords

Ancillary Items - Collection Kits. Ancillary Items - Reagents. Aptima BV Assay. Aptima Combo 2 Assay for CT/NG.

The recommended dosage of Viltepso is 80 mg/kg administered once weekly as a 60-minute intravenous infusion. VI. Billing Code/Availability Information HCPCS Code: • J3490 – Unclassified drugs. NDC: • Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1. Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc.; August 2020.

NDC: • Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1. Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc.; August 2020. Accessed August 2020. 2.

Viltepso is a clear and colorless solution. Viltepso is supplied in single-dose vials containing 250 mg/5 mL viltolarsen (50 mg/mL) in 0.9% sodium chloride. VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients amenable to exon 53 skipping. Accelerated approval is based on an increase in dystrophin. There is an ongoing study to confirm the clinical benefit of VILTEPSO. If you are a healthcare provider who treats patients with DMD The use of viltolarsen (Viltepso) for Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping does not meet the definition of medical necessity, defined as delivery of a service by a qualified healthcare provider, exercising prudent clinical 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.
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Generic name: viltolarsen. Dosage form: Injection. Company: NS Pharma, Inc. Treatment for: Duchenne Muscular Dystrophy. Viltepso (viltolarsen) is an antisense oliogonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in VILTEPSO is a drug for the treatment of a particular type of Duchenne muscular dystrophy (DMD). It is to be used only in patients who have a specific mutation of the dystrophin gene.

2020-08-13 · The US Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection 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. VILTEPSO prescription and dosage sizes information for physicians and healthcare professionals.
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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.

colchicine and amox 30 Sep 2020 informed of the latest FDA drug approvals, medications in development, and upcoming specialty/biosimilar pipeline Viltepso (viltolarsen) – Duchenne Muscular Dystrophy. A non-infectious virus is used to insert the d Physicians and pharmacists at your health plan or at one of our partners, Diplomat or Express Scripts. The list to follow specifies who performs the review and  27 Aug 2020 “The FDA's acceptance of our NDA [new drug application] for casimersen is an important step toward our goal of rapidly bringing therapies to  3 Jan 2021 You will need pkge. acetaminophen 25 mg 60 pills in a package Viltepso Viltepso viltolarsen is an antisense oliogonucleotide tylenol cocaine for the. their respective tylenol cocaine insert center at 1-800-222-1222.