What Is Viltepso? Viltepso (viltolarsen) is an antisense oligonucleotide used to treat Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.. What Are Side Effects of Viltepso? Side effects of Viltepso …

Neurology. 2020:10.1212/WNL.0000000000009233. 27. Viltepso (viltolarsen, injection).[package insert] NS Pharma, Inc. Paramus, NJ. August 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. Exon skipping is a treatment strategy in which sections of genetic code are “skipped” (spliced out, or left out) during the protein manufacturing process, allowing cells to create shortened but partially functional dystrophin protein, the muscle protein missing in DMD. Administration (FDA) has approved VILTEPSO™ (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy.

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. 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 (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration. 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.

Absorption.

Viltepso Harvard Pilgrim Medical C20597-A 2021_01MAY21_P.docx skeletal muscle observed in patients treated with Viltepso. Viltepso [package insert].

In March 2020 , VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy. About VILTEPSO™ (viltolarsen) injection Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations. In March 2020 , VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy. VILTEPSO (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration.

• Package Insert For Information Only - Not A Controlled Copy. Xpert® MTB/RIF 4 Xpert® MTB/RIF 301-1404, Rev. F August 2019 6.2 Storage and Handling • Store the Xpert MTB/RIF Assay cartridges and reagents at 2 – 28 °C. • Do not use reagents or cartridges that have passed the expiration date.

1 Dec 2013 within the drug formulary information on www.healthpartners.com. Claims Viltolarsen (Viltepso) 73292001101 8/12/2020 10/28/2020. 10/1/ Read breaking news on new FDA drug and device approvals from BioSpace, the Home of the Life Sciences Industry. 7.4 (Normosol-R pH 7.4). Caloric content, 21 kcal/L, Not specified in package insert. Labeled indications, Source of water and electrolytes.

Reference ID: 4655432 ll ,i wkh yroxph ri 9,/7(362 uhtxluhg lv p/ ru pruh gloxwlrq lv qrw uhtxluhg dqg wkh uhtxluhg dprxqw ri 9,/7(362 vkrxog eh sodfhg lqwr dq hpsw\ lqixvlrq edj The recommended dosage of Viltepso is 80 mg/kg administered once weekly • 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.
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Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc.; August 2020.

Caloric content, 21 kcal/L, Not specified in package insert.
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8.2 8.5 11 12.1 12.2 13 13.1 16.1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use

Status. VILTEPSO™ is an antisense oligonucleotide 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 (FDA label document). VILTEPSO (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy (DMD) VILTEPSO™ (viltolarsen) is an antisense oligonucleotide drug indicated to treat Duchenne muscular dystrophy (DMD), a rare genetic disorder, in patients with a confirmed DMD gene mutation that is vulnerable to exon 53 skipping therapy. Se hela listan på musculardystrophynews.com 8.2 8.5 11 12.1 12.2 13 13.1 16.1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use About VILTEPSO™ (viltolarsen) injection. Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations. In March 2020, VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy.

2020-08-13

Viltolarsen is administered by intravenous infusion and is assumed to have a bioavailability of 100%.

2. Topaloglu H, Gloss D, Moxley RT 3 rd Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1. Viltepso [package insert].