Atazanavir (Reyataz) Label Update Adds Kidney Warning, Drug Interactions


Product label information for the HIV protease inhibitor atazanavir (brand name Reyataz) was recently revised to include new warnings about cholelithiasis or gall bladder stones and interstitial nephritis (a type of kidney inflammation), as well as interactions with several other medications, including the hepatitis C virus protease inhibitor boceprevir (Victrelis).

Below is an edited excerpt from a recent announcement from the U.S. Food and Drug Administration detailing the changes.

Recent Changes to the Reyataz (atazanavir sulfate) Capsule Labeling

February 8, 2013 -- Recently FDA approved changes to the Reyataz (atazanavir sulfate) capsule labeling to include the following changes.

Section 5 Warnings and Precautions was revised to include cholelithiasis as follows:

Nephrolithiasis and Cholelithiasis

Cases of nephrolithiasis and/or cholelithiasis have been reported during postmarketing surveillance in HIV-infected patients receiving REYATAZ therapy. Some patients required hospitalization for additional management and some had complications. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made. If signs or symptoms of nephrolithiasis and/or cholelithiasis occur, temporary interruption or discontinuation of therapy may be considered.

In section 6 Adverse Reactions: Postmarketing Experience, interstitial nephritis was added.

In section 7 Drug Interactions: information regarding coadministration with boceprevir, carbamazepine, phenytoin, phenobarbital, lamotrigine and voriconazole was added.

Reyataz is a product of Bristol-Myers Squibb.

The complete revised label will be available soon at Drugs@FDA.



R Klein and K Struble, Food and Drug Administration. Recent changes to the Reyataz (atazanavir sulfate) capsule labeling. February 8, 2013.