SAFETY PROFILE

EVOTAZ DEMONSTRATED A SAFETY AND TOLERABILITY PROFILE SIMILAR TO REYATAZ (atazanavir/ritonavir) THROUGH 144 WEEKS1

Selected Adverse Reactions (Grades 2-4) Reported in ≥2% of Treatment-Naive Adults in the EVOTAZ arm in Study 1141

  EVOTAZ arm
(n=344)
REYATAZ /r arm
(n=348)
Jaundice 6% 3%
Rash 5% 4%
Ocular icterus 4% 2%
Nausea 2% 2%
Diarrhea 2% 1%
Headache 2% 1%
  • Discontinuation rates due to adverse events through 144 weeks were similar for the EVOTAZ and REYATAZ/r arms (11% vs 11%, respectively)
  • Elevations in bilirubin were common and mostly asymptomatic in both EVOTAZ and REYATAZ/r arms (73% vs 66%, respectively)
  • Jaundice and ocular icterus were cosmetic and reversible upon discontinuation in both EVOTAZ and REYATAZ/r arms

r=ritonavir

SELECTED IMPORTANT SAFETY INFORMATION

  • Severe Skin Reactions: Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions, including drug rash, eosinophilia and systemic symptoms (DRESS) syndrome, have been reported in patients receiving atazanavir. Discontinue if severe rash develops. Mild-to-moderate maculopapular skin eruptions have also been reported, and generally did not result in treatment discontinuation

EVOTAZ: Additional WARNINGS AND PRECAUTIONS

  • Effects on Serum Creatinine: Cobicistat decreases estimated creatinine clearance (CrCl) by inhibiting tubular secretion of creatinine without affecting actual renal glomerular function. Consider this effect when interpreting changes in estimated CrCl in patients initiating EVOTAZ, particularly in patients with medical conditions or receiving drugs needing monitoring with estimated CrCl. Assess estimated CrCl prior to initiating EVOTAZ. Dosage recommendations are not available for drugs that require dosage adjustment in cobicistat-treated patients with renal impairment; consider alternative medications that do not require dosage adjustment in these patients. Patients who experience a confirmed increase in serum creatinine >0.4 mg/dL from baseline should be closely monitored for renal safety