Generic name: elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil fumarate 300mg
Dosage form: tablet, film coated
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The recommended dosage of STRIBILD is one tablet taken orally once daily with food [See Clinical Pharmacology (12.3)].
Dosage Adjustment in Patients with Renal Impairment
Initiation of STRIBILD in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with STRIBILD, as the dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (DF) cannot be achieved [See Warnings and Precautions (5.3), Adverse Reactions (6.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Clinical Studies (14)].
Dosage in Patients with Hepatic Impairment
No dosage adjustment of STRIBILD is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of STRIBILD in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, STRIBILD is not recommended for use in patients with severe hepatic impairment [See Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Testing Prior to Initiation of STRIBILD
Prior to initiation of STRIBILD, patients should be tested for hepatitis B infection [See Warnings and Precautions (5.2)] and estimated creatinine clearance, urine glucose, and urine protein should be documented in all patients [See Warnings and Precautions (5.3)].