Viltepso [package insert]. 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

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 [package insert]. Paramus, NJ; NS Pharma, Inc.; August 2020. Accessed August 2020. 2. Topaloglu H, Gloss D, Moxley RT 3 rd 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

What Are Side Effects of Viltepso? Side effects of Viltepso … VILTEPSO is administered via intravenous infusion using a peripheral or central venous catheter. Flush the intravenous access line with 0.9% Sodium Chloride Injection, USP, after infusion. 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 1. Viltepso [package insert]. Paramus, NJ: NS Pharma, Inc.; August 2020.

Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc.; August 2020. Accessed August 2020.

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.

Practice guideline update summary: Corticosteroid treatment of Duchenne muscular dystrophy: Report of the Guideline VILTEPSO™ (viltolarsen) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy without approval. ©2020, Magellan Rx Management • J3490 – Unclassified drugs. NDC: • Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1.

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

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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. Absorption. Viltolarsen is administered by intravenous infusion and is assumed to have a bioavailability of 100%. 8 In a phase 1 dose-escalation trial of 10 patients given either 1.25, 5, or 20 mg/kg weekly for 12 weeks, the mean C max was 6040 ± 300 ng/mL in the low dose group and 70,200 ± 44,900 ng/mL in the high dose group on initial dose, with the corresponding final dose values of 5640 2019-01-22 ABECMA ® (idecabtagene vicleucel) ABECMA ® (idecabtagene vicleucel) FULL PRESCRIBING INFORMATION WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA.
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Topaloglu H, Gloss D, Moxley RT 3rd, et al. Practice guideline update summary: Corticosteroid treatment of Duchenne muscular dystrophy: Report of the Guideline VILTEPSO™ (viltolarsen) Prior Auth Criteria Proprietary Information.

Ancillary Items - Reagents. Aptima BV Assay. Aptima Combo 2 Assay for CT/NG.
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Package Insert For in-vitro diagnostic use Availability of individual reports may be subject to product purchased. Table of contents Genetic Health Risk Intended use Important warnings and limitations Test performance User studies Specific test information BRCA1/BRCA2 (Selected Variants) Indications for use

Mol Ther Nucleic Acids. 2018;13:442– 449. doi:10.1016/j.omtn.2018.09.017 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.

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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.

This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with Viltepso. 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. Topaloglu H, Gloss D, Moxley RT 3rd, et al.