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.

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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.

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