Source: FDA, National Drug Code (US) Revision Year: 2020
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. Each milliliter of VILTEPSO contains 50 mg viltolarsen and 9 mg sodium chloride in water for injection. The final product is adjusted to a pH ranging between 7.0 and 7.5 using hydrochloric acid and/or sodium hydroxide.
Viltolarsen is an antisense oligonucleotide of the phosphorodiamidate morpholino oligomer (PMO) subclass. PMOs are synthetic molecules in which the five-membered ribofuranosyl rings found in natural DNA and RNA are replaced by a six-membered morpholino ring. Each morpholino ring is linked through an uncharged phosphorodiamidate moiety rather than the negatively charged phosphate linkage that is present in natural DNA and RNA. Each phosphorodiamidate morpholino subunit contains one of the heterocyclic bases found in DNA (adenine, cytosine, guanine, or thymine). Viltolarsen contains 21 linked subunits. The molecular formula of viltolarsen is C244H381N113O88P20 and the molecular weight is 6924.82 daltons. The structure and base sequence of viltolarsen are shown in Figure 1.
Figure 1. Structural Formula of Viltolarsen:
Dosage Forms and Strengths |
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VILTEPSO is a clear and colorless solution available as follows:
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How Supplied |
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VILTEPSO injection is supplied in single-dose vials. The solution is clear and colorless.
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Drug | Countries | |
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VILTEPSO | Japan, United States |
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