Industry Webcast

Essentials of XOCOVA®: A New Paradigm in COVID-19 PreventionIndustry Webcast Sponsored by Shionogi Inc.; Not for CME/CE Credit

The period immediately following COVID-19 exposure represents a critical opportunity for intervention. This program will examine the ongoing burden of COVID-19, review the science supporting early antiviral intervention following exposure, and highlight pivotal Phase 3 SCORPIO-PEP data evaluating XOCOVA (ensitrelvir) for PEP. Attendees will gain practical insightsinto patient identification, treatment considerations, and real-world implementation scenarios to help reduce the risk of symptomatic COVID-19 following exposure.

Indication
XOCOVA (ensitrelvir) is indicated for post-exposure prophylaxis (PEP) of coronavirus disease 2019 (COVID-19) in adults and adolescents aged 12 years 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 other 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 or BCRP. In patients receiving orinitiating 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 the risk of potential drugdrug interactions can be appropriately 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 provided under the Sessions Materials tab on this PrimaryCareNow platform.