Atazanavirdosage

Pretreatment testing: Renal laboratory testing should be performed in all patients prior to initiation of EVOTAZ and continued during treatment with EVOTAZ. Hepatic testing should be performed in patients with underlying liver disease prior to initiation of EVOTAZ and continued during treatment with EVOTAZ.

Recommended dosage: One tablet once daily, taken orally with food in adults and pediatric patients weighing at least 35 kg.

Renal impairment: EVOTAZ is not recommended for use in treatment-experienced patients with end-stage renal disease managed with hemodialysis.

Hepatic impairment: EVOTAZ is not recommended in patients with any degree of hepatic impairment.

2.1 Laboratory

Testing Prior to Initiation and During Treatment with EVOTAZ Renal Testing 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. Cobicistat decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. 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. Hepatic Testing Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of EVOTAZ and continued during treatment with EVOTAZ.

2.2 Recommended

Dosage EVOTAZ is a fixed-dose tablet containing 300 mg of atazanavir and 150 mg of cobicistat. The recommended dosage of EVOTAZ is one tablet taken once daily orally with food in both treatment-naive and treatment-experienced patients with HIV-1:

Adult patients

Pediatric patients weighing at least 35 kg Administer EVOTAZ in conjunction with other antiretroviral agents. Dose separation may be required when taken with H 2 -receptor antagonists or proton-pump inhibitors.

2.3 Dosage in

Patients with Renal Impairment EVOTAZ is not recommended in treatment-experienced patients with HIV-1 who have end-stage renal disease managed with hemodialysis. 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.

2.4 Not Recommended in

Patients with Any Degree of Hepatic Impairment EVOTAZ is 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.