Letermovir is available as a 20-mg/mL concentrate for injection in single-dose (preservative-free) vials containing 240 mg (12 mL) or 480 mg (24 mL) of the drug, respectively, packaged in 30-mL vials.3398 Each mL of concentrate for injection also contains hydroxypropyl-beta-cyclodextrin 150 mg, sodium chloride 3.1 mg, and sodium hydroxide in water for injection.3398 The amount of sodium hydroxide used to adjust the pH may vary.3398
Letermovir concentrate for injection must be diluted prior to administration.3398 The appropriate volume of the concentrate should be withdrawn from the vial and transferred to an infusion bag containing 250 mL of sodium chloride 0.9% or dextrose 5%.3398 The diluted solution for infusion should be gently mixed and should not be shaken.3398
pH
The concentrate for injection has a pH adjusted to approximately 7.5.3398
Trade Name(s)
Prevymis
The entire contents of the intravenous bag containing the diluted solution of letermovir for infusion should be administered as an intravenous infusion at a constant rate over 1 hour through a peripheral catheter or central venous line.3398 The drug should not be administered by intravenous bolus injection.3398
Letermovir concentrate for injection is a clear, colorless solution that forms a clear solution ranging from colorless to yellow upon dilution; variations in color within this range do not affect product quality.3398 Intact vials should be stored at controlled room temperature in the original carton to protect from light.3398
Letermovir concentrate for injection should be visually inspected for particulate matter and discoloration in the vial and again once the solution has been diluted in the intravenous infusion bag; if visible particulates are present or if discoloration occurs, the solution should not be used and should be discarded.3398 Vials are for single use only; any unused portion should be discarded.3398
Sorption
Letermovir is noted to be compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), and polyolefin (polypropylene and polyethylene) intravenous infusion bags, as well as PVC, polyethylene, polybutadiene, silicone rubber, styrene-butadiene copolymer, styrene-butadiene-styrene copolymer, and polystyrene infusion sets.3398 Only intravenous infusion bags and infusion sets made of these materials are recommended for use with letermovir.3398
Letermovir also is compatible with radiopaque polyurethane catheters; however, the drug is not recommended for use with polyurethane-containing intravenous administration set tubing.3398
Plasticizer Leaching
Letermovir is compatible with materials containing plasticizers such as diethylhexyl phthalate (DEHP), trioctyl trimellitate (TOTM), and benzyl butyl phthalate.3398
For a list of references cited in the text of this monograph, search the monograph titled References.