Generic name: ATAZANAVIR SULFATE 300mg, COBICISTAT 150mg
Dosage form: tablet
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Laboratory Testing Prior to Initiation and During Treatment with EVOTAZ
Prior to starting EVOTAZ, assess estimated creatinine clearance because cobicistat decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Warnings and Precautions (5.3)]. When coadministering EVOTAZ with tenofovir disoproxil fumarate (tenofovir DF), assess estimated creatinine clearance, urine glucose, and urine protein at baseline and routinely monitor during treatment [see Warnings and Precautions (5.4)].
In patients with underlying hepatitis B or C viral infections, conduct hepatic laboratory testing prior to initiating therapy and during treatment with EVOTAZ [see Warnings and Precautions (5.6)].
EVOTAZ is a fixed-dose combination product containing 300 mg of atazanavir and 150 mg of cobicistat. In treatment-naive and -experienced adults, the recommended dosage of EVOTAZ is one tablet taken once daily orally with food [see Clinical Pharmacology (12.3)]. Administer EVOTAZ in conjunction with other antiretroviral agents [see Drug Interactions (7)].
When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required [see Drug Interactions (7)].
Dosage in Patients with Renal Impairment
EVOTAZ coadministered with tenofovir DF is not recommended in patients with estimated creatinine clearance below 70 mL/min. Coadministration of EVOTAZ and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended[see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].
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- Drug class: antiviral combinations