Renal Testing Recommendations Added to Atazanavir Labeling

Prior to initiating treatment and during treatment, all patients should undergo renal lab testing
Prior to initiating treatment and during treatment, all patients should undergo renal lab testing

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.