DOSING & ADMINISTRATION

EVOTAZ: COFORMULATED TO BE ONE PILL, ONCE DAILY1

EVOTAZ HIV treatment pill bottle.

Actual pill size: (19 mm x 11 mm x 7 mm)

EVOTAZ HIV treatment pill bottle.

Actual pill size: (19 mm x 11 mm x 7 mm)

  • For treatment-naive and experienced adults and pediatric patients weighing at least 35 kg the recommended dosage of EVOTAZ is one tablet taken once daily with a meal or a snack as part of a combination therapy in HIV-1
  • EVOTAZ contains 300 mg of REYATAZ (atazanavir) and 150 mg of cobicistat
  • EVOTAZ is bioequivalent to its individual components
  • When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required
  • 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
  • EVOTAZ coadministered with tenofovir DF is not recommended in patients with estimated CrCl <70 mL/min or in combination with concomitant or recent use of a nephrotoxic agent
  • EVOTAZ is not recommended in treatment-experienced patients with
    end-stage renal disease managed with hemodialysis
  • Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of EVOTAZ and continued during treatment with EVOTAZ
  • EVOTAZ is not recommended in patients (regardless of treatment history) with any degree of hepatic impairment
  • 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
  • For treatment-naive and experienced adults and pediatric patients weighing at least 35 kg the recommended dosage of EVOTAZ is one tablet taken once daily with a meal or a snack as part of a combination therapy in HIV-1
  • EVOTAZ contains 300 mg of REYATAZ (atazanavir) and 150 mg of cobicistat
  • EVOTAZ is bioequivalent to its individual components
  • When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required
  • 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
  • EVOTAZ coadministered with tenofovir DF is not recommended in patients with estimated
    CrCl <70 mL/min or in combination with concomitant or recent use of a nephrotoxic agent
  • EVOTAZ is not recommended in treatment-experienced patients with end-stage renal disease managed with hemodialysis
  • Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of EVOTAZ and continued during treatment with EVOTAZ
  • EVOTAZ is not recommended in patients (regardless of treatment history) with any degree of hepatic impairment
  • 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

Please see US Important Safety Information for Contraindications on coadministration with drugs highly dependent on CYP3A4 or UGT1A1, with drugs that strongly induce CYP3A4, and the Drug Interactions sections.