Genvoya Dosage

Testing Prior to Initiation and During Treatment with GENVOYA

Prior to initiation of GENVOYA, patients should be tested for hepatitis B virus infection [see Warnings and Precautions (5.1)].

It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose and urine protein be assessed before initiating GENVOYA and during therapy in all patients as clinically appropriate [see Warnings and Precautions (5.4)].

Recommended Dosage

GENVOYA is a four-drug fixed dose combination product containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (TAF). The recommended dosage of GENVOYA is one tablet taken orally once daily with food in adults and pediatric patients 12 years of age and older with body weight at least 35 kg and creatinine clearance greater than or equal to 30 mL per minute [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Not Recommended in Patients with Severe Renal Impairment

GENVOYA is not recommended in patients with estimated creatinine clearance below 30 mL per minute [see Use in Specific Populations (8.6)].

Not Recommended in Patients with Severe Hepatic Impairment

GENVOYA is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].