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HIGHLIGHTS OF PRESCRIBING INFORMATION for DESCOVY. …

Gilead Sciences 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use DESCOVY safely and effectively. See full PRESCRIBING INFORMATION for DESCOVY. DESCOVY (emtricitabine and tenofovir alafenamide) tablets, for oral use Initial Approval: 2015 WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full PRESCRIBING INFORMATION for complete boxed warning. Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY.

2.3 Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 25 kg DESCOVY is a two-drug fixed dose combination product containing 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of DESCOVY for treatment of HIV-1 is one tablet taken . .

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