FDA approves 5 kg weight band for atazanavir

The FDA approved a new pediatric weight band for atazanavir oral powder, according to a press release. The revised label includes dosing recommendations for patients with HIV at least 3 months of age who weigh a minimum of 5 kg.

Atazanavir (Reyataz, Bristol-Myers Squibb) was previously recommended for patients in the same age group who weighed at least 10 kg.

According to the FDA, the regimen must be taken in combination with the oral solution, ritonavir (Norvir, AbbVie). The daily dosage for patients who weigh 5 kg to less than 15 kg is 200 mg (four packets) of atazanavir plus 80 mg of ritonavir. Doses may be lowered to 150 mg (three packets) of atazanavir, but only in patients weighing 5 kg to less than 10 kg who do not tolerate the recommended dose and have not previously received an HIV protease inhibitor. In this case, patients must be closely monitored.

The safety profile of the oral powder was similar to the capsule form of Reyataz, which was observed in clinical studies. The most frequent Grade 3 to 4 laboratory abnormalities associated with the oral powder in pediatric patients weighing 5 kg to less than 35 kg were increases in amylase (33%), neutropenia (9%), serum glutamic pyruvic transaminase/alanine aminotransferase ratios (9%), lipase (8%) and elevated bilirubin (>2.6 times the upper limit of the normal range; 16%). All other incidences of abnormalities occurred with a frequency of less than 3%, according to the FDA.