FDA Expands Ped Indication for Reyataz Oral Powder
The Food and Drug Administration (FDA) has approved a pediatric labeling updates for Reyataz (atazanavir; Bristol-Myers Squibb) oral powder to include dosing recommendations for patients aged ≥3 months weighing ≥5kg.
Prior to the expanded approval, Reyataz oral powder was indicated for patients aged ≥3 months weighing ≥10kg. Reyataz oral powder is not recommended for use in children who weigh <5kg. The new dosing states a 200mg dose (4 packets) plus 80mg ritonavir oral solution once daily. Only patients weighing 5–<10kg who cannot tolerate the 200mg (4 packets) dose and have not previously taken an HIV protease inhibitor may take 150mg (3 packets) with close viral load monitoring.
The pediatric safety profile for Reyataz oral powder was generally similar to that seen in clinical studies of pediatric patients taking Reyataz capsules. Reyataz is an azapeptide HIV-1 protease inhibitor that selectively inhibits the virus-specific processing of viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, thus preventing formation of mature virions.
Reyataz oral powder is supplied as a 50mg strength packets in 30-count cartons.
For more information call (800) 721-5072 or visit FDA.gov.