Generic name: elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil fumarate 300mg
Dosage form: tablet, film coated
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Testing Prior to Initiation and During Treatment with STRIBILD
Prior to initiation of STRIBILD, patients should be tested for hepatitis B virus infection [see Warnings and Precautions (5.2)].
It is recommended that serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating STRIBILD and during therapy in all patients as clinically appropriate [see Warnings and Precautions (5.3)].
STRIBILD is a four-drug fixed dose combination product containing 150 mg of elvitegravir, 150 of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir DF. The recommended dosage of STRIBILD is one tablet taken orally once daily with food in adults and pediatric patients 12 years of age and older with a body weight at least 35 kg (at least 77 lbs) and creatinine clearance greater than or equal to 70 mL per minute [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)].
No data are available to make dose recommendations for pediatric patients with renal impairment.
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- Drug class: antiviral combinations