Prevymis Description

PREVYMIS Tablets: PREVYMIS 240 mg tablet is a yellow oval tablet. Each tablet is debossed with "591" on one side and corporate logo on the other side.
PREVYMIS 480 mg tablet is a pink oval, bi-convex tablet. Each tablet is debossed with "595" on one side and corporate logo on the other side.
Each tablet contains either 240 mg or 480 mg of letermovir.
PREVYMIS Concentrate for Solution for Infusion: PREVYMIS concentrate for solution for infusion is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial.
Each 1 mL of solution contains 20 mg letermovir.
PREVYMIS 240 mg/12 mL (20 mg/mL) concentrate for solution for infusion is supplied as a clear solution in a single-dose vial.
PREVYMIS 480 mg/24 mL (20 mg/mL) concentrate for solution for infusion is supplied as a clear solution in a single-dose vial.
Chemistry: Letermovir has a molecular formula of C₂₉H₂₈F₄N₄O₄ and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water.
Excipients/Inactive Ingredients: PREVYMIS Tablets: PREVYMIS tablets contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone 25, colloidal silicon dioxide, magnesium stearate and film-coated with a coating material containing the following inactive ingredients: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide yellow, and (only for 480 mg tablets) iron oxide red. Carnauba wax is added as a polishing agent.
PREVYMIS Concentrate for Solution for Infusion: Each 1 mL of PREVYMIS concentrate for solution for infusion contains the following inactive ingredients: hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5.