HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GENVOYA safely and effectively. See full prescribing information for GENVOYA.
GENVOYA ® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use
Initial U.S. Approval: 2015
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
GENVOYA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA. Hepatic function should be monitored closely in these patients. If appropriate, anti-hepatitis B therapy may be warranted. (5.1)
RECENT MAJOR CHANGES
Boxed Warning, Lactic Acidosis/Severe Hepatomegaly with Steatosis [removed]
04/2017
Contraindications (4)
09/2016
Warnings and Precautions, Lactic Acidosis/Severe Hepatomegaly with Steatosis (5.5)
04/2017
Warnings and Precautions, Fat Redistribution [removed]
04/2017
Warnings and Precautions, Bone Loss and Mineralization Defects [removed]
12/2016
INDICATIONS AND USAGE
GENVOYA is a four-drug combination of elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat, a CYP3A inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA. (1)
DOSAGE AND ADMINISTRATION
Testing: Prior to initiation of GENVOYA, patients should be tested for hepatitis B virus infection. Assess serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein before initiating GENVOYA and during therapy in all patients as clinically appropriate. (2.1)
Recommended dosage: One tablet taken orally once daily with food in patients 12 years old and older with body weight at least 35 kg and a creatinine clearance greater than or equal to 30 mL per minute. (2.2)
Renal impairment: GENVOYA is not recommended in patients with estimated creatinine clearance below 30 mL per minute. (2.3)
Hepatic impairment: GENVOYA is not recommended in patients with severe hepatic impairment. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide. (3)
CONTRAINDICATIONS
Coadministration of GENVOYA is contraindicated with drugs that:
Are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious adverse events. (4)
Strongly induce CYP3A, which may lead to lower exposure of one or more components and loss of efficacy of GENVOYA and possible resistance. (4)
WARNINGS AND PRECAUTIONS
Risk of a