On June 2, 2014, FDA approved a new dosage form, Reyataz (atazanavir) oral powder for use in combination with other antiretroviral agents for the treatment of HIV-1, in patients over 3 months of age and between 10kg to < 25 kg. The first part of this announcement summarizes the changes relevant to the oral formulation and use in pediatric patients. The second part summarizes other general changes to the label.
- The DOSAGE AND ADMINISTRATION was updated to include information on the oral powder formulation
REYATAZ oral powder is for use in treatment-naive or treatment-experienced pediatric patients who are at least 3 months of age and weighing at least 10 kg and less than 25 kg. REYATAZ oral powder must be mixed with food or beverage for administration and ritonavir must be given immediately afterwards. The table below displays the recommended dosage of REYATAZ oral powder and ritonavir.
|Body Weight||Daily Dosage of REYATAZ
|Daily Dosage of Ritonavir Oral Solution
|10 kg to less than 15g||200 mg (4 packets)b||80 mg|
|15 kg to less than 25g||250 mg (5 packets)b||80 mg|
b Each packet contains 50 mg of REYATAZ.