Actor portrayals.
Safety profile
Actor portrayals.
Demonstrated safety and tolerability profile1-3
XOCOVA SCORPIO-PEP safety profile
| XOCOVA n=1190 | Placebo n=1187 | |
|---|---|---|
| The most common AEs (regardless of causality) occurring in ≥1% of the XOCOVA group and at a greater frequency compared to placebo1: | ||
| Headache | 2.9% | 2.6% |
| Diarrhea | 1.7% | 1.3% |
| Cough | 1.1% | 0.6% |
| Discontinuation of study intervention due to AE1 | <0.1% | <0.1% |
| Hospitalizations or deaths2 | 0 | 0 |
| Laboratory abnormalities1 | ||
| Asymptomatic hemoglobin declines from baseline of >2 g/dL | 3% | 1% |
Advise pregnant women and females of reproductive potential that XOCOVA may cause fetal harm. Women should use effective contraception while taking XOCOVA and for 2 weeks after the final dose.1
XOCOVA had no reports of dysgeusia (taste disturbance) in the SCORPIO-PEP trial2,3
XOCOVA has a well-established drug interaction profile1
XOCOVA is contraindicated when administered with drugs primarily metabolized by CYP3A or with strong CYP3A inducers. Review all concomitant medications to assess potential drug-drug interactions and determine if those medications require a dose adjustment, interruption, and/or additional monitoring.1 To learn more about potential drug interactions, please see Section 7 of the full Prescribing Information.
The overall safety profile of XOCOVA is based on data from 2831 adults and adolescents exposed to the recommended dosage and duration of XOCOVA in multiple controlled clinical trials, including SCORPIO-PEP.1
AE=adverse event.
Review XOCOVA once-daily dosing
See XOCOVA drug interactions
INDICATION & IMPORTANT SAFETY INFORMATION
INDICATION
XOCOVA (ensitrelvir) is indicated for 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.
IMPORTANT SAFETY INFORMATION
Contraindications
XOCOVA is contraindicated in patients with a history of clinically significant hypersensitivity reactions to XOCOVA or any of its components. XOCOVA is also contraindicated when administered with drugs primarily metabolized by CYP3A for which elevated concentrations may be associated with serious and/or life-threatening reactions or when administered with strong CYP3A inducers because they may significantly reduce XOCOVA plasma concentrations leading to potential loss of virologic response.
Embryofetal Toxicity
Based on animal data, XOCOVA may cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential that XOCOVA may cause fetal harm. Verify pregnancy status of females of reproductive potential before initiating XOCOVA and advise using effective contraception during XOCOVA use and for 2 weeks after the final dose.
Risk of Serious Adverse Reactions Due to Drug Interactions
XOCOVA is a strong CYP3A inhibitor and an inhibitor of P-gp and BCRP. In patients receiving or initiating medications metabolized by CYP3A or transported by P-gp or BCRP, XOCOVA may increase plasma concentrations of those medications and may potentially lead to severe, life-threatening, or fatal events from increased exposure. CYP3A inducers may decrease concentrations of XOCOVA, leading to loss of therapeutic effect.
Before prescribing XOCOVA, review all concomitant medications to assess potential drug-drug interactions and determine if those medications require a dose adjustment, interruption, and/or additional monitoring. Consider the benefit of XOCOVA and whether risk of potential drug-drug interactions can be managed.
Hypersensitivity Reactions Including Anaphylaxis
Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, and angioedema have been reported. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue XOCOVA and initiate appropriate treatment.
Lactation
There are no data on the presence of XOCOVA in human milk, effects on breastfed infants, or effects on milk production. XOCOVA was present in the milk of lactating rats. Advise women not to breastfeed while on XOCOVA and for 2 weeks after the final dose.
Adverse Reactions
The most common adverse events occurring in ≥1% of XOCOVA patients and at greater frequency than placebo, respectively, were headache (2.9% vs 2.6%), diarrhea (1.7% vs 1.3%), and cough (1.1% vs 0.6%).
Laboratory Abnormalities
Asymptomatic hemoglobin declines from baseline of >2 g/dL occurred in XOCOVA and placebo patients (3% vs 1%, respectively).
Please see full Prescribing Information.
References: 1. XOCOVA [package insert]. Florham Park, NJ: Shionogi Inc. 2. Hayden FG, Shinkai M, Clark TW, et al. Ensitrelvir for Covid-19 postexposure prophylaxis in household contacts. N Engl J Med. 2026;394(19):1905-1915. 3. Data on file. Shionogi Inc. Florham Park, NJ.