Ensitrelvir

XOCOVA is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (M pro: also referred to as 3CL pro or nsp5 protease) inhibitor, is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID‑19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.

Ensitrelvir is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antiviral drug.

Verify pregnancy status of females of reproductive potential prior to initiating XOCOVA. Begin XOCOVA as soon as possible and within 72 hours following contact with an individual who has COVID-19. Dosage: 375 mg (three 125-mg tablets taken at the same time) orally on Day 1 and 125 mg (one 125-mg tablet) orally on Days 2 to 5 taken with or without food.

XOCOVA is contraindicated in patients with a history of clinically significant hypersensitivity reactions to ensitrelvir or any other components of the product. XOCOVA is contraindicated in patients taking drugs that are: Primarily metabolized by CYP3A for which elevated concentrations may be associated with serious and/or life-threatening reactions and Strong CYP3A inducers because they may significantly reduce ensitrelvir plasma concentrations, leading to the potential loss of virologic response. History of clinically significant hypersensitivity reactions to ensitrelvir or any other components of the product.

Embryofetal toxicity: Based on animal data, XOCOVA may cause fetal harm. Advise pregnant women and females of reproductive potential that XOCOVA may cause fetal harm. Advise females of reproductive potential to use effective contraception during XOCOVA use and for 2 weeks after the final dose. The concomitant use of XOCOVA and certain other drugs may result in potentially significant drug interactions. Consult the Full Prescribing Information prior to and during treatment for potential drug interactions. Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, and angioedema, have been reported with XOCOVA. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue XOCOVA and initiate appropriate treatment.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions including anaphylaxis The most common adverse events (regardless of causality) occurring in ≥1% of the XOCOVA group and at a greater frequency compared to placebo were headache, diarrhea, and cough.

Co-administration of XOCOVA can alter the plasma concentrations of other drugs, and other drugs may alter the plasma concentrations of XOCOVA. Consider the potential for drug interactions prior to and during XOCOVA use and review concomitant medications during XOCOVA use.

Store XOCOVA in the original package at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).