Generic name: ATAZANAVIR SULFATE 300mg, COBICISTAT 150mg
Dosage form: tablet
Medically reviewed by Drugs.com. Last updated on Apr 22, 2020.
Laboratory Testing Prior to Initiation and During Treatment with EVOTAZ
Renal laboratory testing should be performed in all patients prior to initiation of EVOTAZ and continued during treatment with EVOTAZ. Renal laboratory testing should include estimated creatinine clearance, serum creatinine, and urinalysis with microscopic examination [see Warnings and Precautions (5.5, 5.6)]. 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. In patients with chronic kidney disease, also monitor serum phosphorus[see Warnings and Precautions (5.4)].
Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of EVOTAZ and continued during treatment with EVOTAZ [see Warnings and Precautions (5.7)].
Recommended Dosage in Adults
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)].
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)].
Not Recommended in Patients with Any Degree of Hepatic Impairment
2.5 Not Recommended During Pregnancy
EVOTAZ is not recommended for use during pregnancy and should not be initiated in pregnant individuals due to substantially lower exposures of cobicistat and consequently, lower exposures of atazanavir, during the second and third trimesters. An alternative regimen is recommended for individuals who become pregnant during therapy with EVOTAZ [see Use in Specific Populations (8.1)].
More about Evotaz (atazanavir / cobicistat)
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- Drug class: antiviral combinations
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