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.
Oral Powder or Use in Pediatric Patients Label Changes:
- The DOSAGE AND ADMINISTRATION was updated to include information on the oral powder formulation
REYATAZ oral powder must be taken with ritonavir and is not recommended for use in children who weigh less than 10 kg or who weigh 25 kg or more.
Dosage and Administration of REYATAZ Oral Powder in Pediatric Patients
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.
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.
Table: Recommended Dosage of REYATAZ Oral Powder and Ritonavir in Pediatric Patients (at least 3 months of age and weighing at least 10 kg and less than 25 kg)a
| Body Weight | Daily Dosage of REYATAZ Oral Powder |
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 |
a The same recommendations regarding the timing and maximum doses of concomitant PPIs and H2RAs in adults also apply to pediatric patients. See Drug Interactions (7) for instructions concerning coadministratrion of acid reducing medications (eg, H2RA or PPIs), and other antiretroviral drugs (eg, efavirenz, tenofovir, and didanosine).
b Each packet contains 50 mg of REYATAZ.
b Each packet contains 50 mg of REYATAZ.
REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 10 kg, distributed by Bristol Myers Squibb.