On September 24, 2015, FDA approved revisions to the Reyataz (atazanavir) oral powder label to include dosing recommendations for patients three months and older weighing at least 5 kg. This represents the addition of a new pediatric weight band. Previously the oral powder formulation was for patients three months and older weighing at least 10 kg.
Reyataz oral powder must be taken with ritonavir and is not recommended for use in children who weigh less than 5 kg.
For children weighing 5 kg to less than 15 kg the daily dosage of Reyataz oral powder is 200 mg (4 packets) plus 80 mg ritonavir oral solution once daily. Only patients weighing 5 to less than 10 kg who do not tolerate the 200 mg (4 packets) dose of Reyataz oral powder and have not previously taken an HIV protease inhibitor, may take 150 mg ( 3 packets) Reyataz oral powder with close HIV viral load monitoring.
The safety profile of REYATAZ in pediatric patients taking REYATAZ oral powder was generally similar to that observed in clinical studies of REYATAZ in pediatric patients taking REYATAZ capsules. The most common Grade 3–4 laboratory abnormalities occurring in pediatric patients weighing 5 kg to less than 35 kg taking REYATAZ oral powder were increased amylase (33%), neutropenia (9%), increased SGPT/ALT (9%), elevation of total bilirubin (>2.6 times ULN, 16%), and increased lipase (8%). All other Grade 3–4 laboratory abnormalities occurred with a frequency of less than 3%.
The pharmacokinetic parameters for atazanavir at steady state in pediatric patients taking the powder formulation are summarized in the Table below.
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Steady-State Pharmacokinetics of Atazanavir (powder formulation) with Ritonavir in HIV-Infected Pediatric Patients |
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|
Body Weight (range in kg) [n] |
atazanavir/ritonavir Dose (mg) |
Cmax ng/mL Geometric Mean (CV%) |
AUC ng•h/mL Geometric Mean (CV%) |
Cmin ng/mL Geometric Mean (CV%) |
|
5 to <10 [20] |
150/80 |
4131 (55%) |
32503 (61%) |
336 (76%) |
|
5 to <10 [10] |
200/80 |
4466 (59%) |
39519 (54%) |
550 (60%) |
|
10 to <15 [18] |
200/80 |
5197 (53%) |
50305 (67%) |
572 (111%) |
|
15 to <25 [32] |
250/80 |
5394 (46%) |
55687 (45%) |
686 (68%) |
|
25 to <35 [8] |
300/100 |
4209 (52%) |
44329 (63%) |
468 (104%) |
You can view the complete label at drugs@fda or dailymed.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the HIV Liaison Program visit the FDA Patient Network
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