October 20, 2017
Renal Testing Recommendations Added to Atazanavir Labeling
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.
For more information visit FDA.gov.