For adults and adolescents 12 years of age and older

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.