The Food and Drug Administration (FDA) has approved updated labeling for Reyataz (atazanavir sulfate; Bristol-Myers Squibb), an HIV-1 protease inhibitor.

The new labeling includes the following updates:

  • Prior to initiating treatment and during treatment, all patients should undergo renal lab testing; tests should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination.
  • Concomitant use of elbasvir/grazoprevir is contraindicated as this may increase the risk of ALT elevations due to a significant increase in grazoprevir plasma concentrations.
  • Chronic kidney disease in patients treated with atazanavir have been reported in postmarketing surveillance; clinicians should consider alternative treatments in patients at high risk for renal disease or with pre-existing renal disease; for patients with progressive kidney disease, discontinuation may be considered.
  • Clinicians should counsel patients that treatment with atazanavir may lead to the development of chronic kidney disease; patients should be told to maintain adequate hydration while on therapy. 

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Reyataz is available in 150mg, 200mg, and 300mg capsules and 50mg/packet oral powder.

For more information visit FDA.gov.