ENSITRELVIR TAB,ORAL

Clinical Criteria Summary

Post-exposure prophylaxis (PEP) 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.

Treatment must be initiated as soon as possible and within 72 hours following contact with an individual who has COVID-19.

Verify pregnancy/lactation status of females of reproductive potential prior to initiating ensitrelvir.

History of clinically significant hypersensitivity to ensitrelvir or any other components of XOCOVA.
Co-administration with drugs primarily metabolized by CYP3A for which elevated concentrations may be associated with serious and/or life-threatening reactions.
Co-administration with strong CYP3A inducers.

May cause fetal harm based on animal reproduction studies; advise pregnant women and females of reproductive potential accordingly.
Advise females of reproductive potential to use effective contraception during ensitrelvir use and for 2 weeks after the final dose.
Insufficient human data for lactation; ensitrelvir was present in the milk of lactating rats.
Advise lactating women not to breastfeed during treatment and for 2 weeks after the final dose due to potential adverse effects in the breastfed child.

Ensitrelvir is a strong CYP3A inhibitor and an inhibitor of P-gp and BCRP; concomitant administration with substrates may result in increased plasma concentrations of the substrates and increased risk of adverse events.
Initiation should be considered only after careful evaluation of relevant clinical and pharmacokinetic factors.
Ensitrelvir is a CYP3A substrate; coadministration with strong CYP3A4 inducers is contraindicated due to potential loss of virologic response.
No dose adjustment is recommended with moderate or weak CYP3A inducers.

Monitor for hypersensitivity reactions including anaphylaxis, anaphylactic shock, and angioedema; immediately discontinue ensitrelvir and initiate appropriate treatment if signs/symptoms occur.
Monitor for reversible, dose-related decrease in HDL cholesterol (approximately 27% decline by Day 6, returning to baseline by Day 15).
Common adverse events include headache (2.9%), diarrhea (1.8%), nasopharyngitis (1.3%), cough (1.2%), fatigue (1.1%), and influenza (1.1%).

No dosage adjustment is recommended for patients with mild, moderate, or severe renal impairment.
Not studied in patients with kidney failure receiving dialysis.
No dosage adjustment is recommended for patients with mild or moderate (Child-Pugh Class A or B) hepatic impairment.
Not studied in severe hepatic impairment (Child-Pugh Class C).

Indicated exclusively for post-exposure prophylaxis; not indicated for the treatment of active SARS-CoV-2 infection.
Not meant to be an alternative or replacement for COVID-19 vaccination but can provide acute, exposure-specific risk reduction (e.g., household contacts, managing outbreaks in vulnerable settings such as a Community Living Center [CLC] or transplant unit).