Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Food and Drug Administration - March 26, 2008
Richard Klein & Kimberly Struble
The Reyataz (atazanavir) Capsule label has been updated to include the dosing recommendations for pediatric patients 6 to 18 years of age.
REYATAZ should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus (a type of brain damage caused by excessive levels of bilirubin).
Important changes made to the product label include the following:
Section 2.2 Recommended Pediatric Dosage was added to the label.
The recommended dosage of REYATAZ for pediatric patients (6 to less than 18 years of age) is based on body weight and should not exceed the recommended adult dosage. REYATAZ Capsules must be taken with food. The data are insufficient to recommend dosing of REYATAZ for any of the following: (1) patients less than 6 years of age, (2) without ritonavir in patients less than 13 years of age, and (3) treatment-experienced pediatric patients with body weight less than 25 kg.
Therapy-Naïve Pediatric Patients
The recommended dosage of REYATAZ with ritonavir in treatment-naïve patients at least 6 years of age is shown in Table 1.
For treatment-naïve patients at least 13 years of age and at least 39 kg, who are unable to tolerate ritonavir, the recommended dose is REYATAZ 400 mg (without ritonavir) once daily with food.
Table 1: Dosage for Treatment-Naïve Pediatric Patients (6 to less than 18 years of age) for REYATAZ Capsules with ritonavir
Body Weight
REYATAZ dose a,b
(mg)
(kg)
(lbs)
15 to less than 25
33 to less than 55
150
80c
25 to less than 32
55 to less than 70
200
100d
32 to less than 39
70 to less than 86
250
100d
at least 39
at least 86
300
100d
a The recommended dosage of REYATAZ can be achieved using a combination of commercially available capsule strengths.
b The dosage of REYATAZ and ritonavir was calculated as follows:
• 15 kg to less than 20 kg: REYATAZ 8.5 mg/kg with ritonavir 4 mg/kg once daily with food.
• at least 20 kg: REYATAZ 7 mg/kg with ritonavir 4 mg/kg once daily with food not to exceed REYATAZ 300 mg and ritonavir 100 mg.
c Ritonavir liquid.
d Ritonavir capsule or liquid.
Therapy-Experienced Pediatric Patients
The recommended dosage of REYATAZ with ritonavir in treatment-experienced patients at least 6 years of age is shown in Table 2.
Table 2: Dosage for Treatment-Experienced Pediatric Patients (6 to less than 18 years of age) for REYATAZ Capsules with ritonavir
Body Weight
REYATAZ dose a,b
(mg)
ritonavir dose b
(mg)
(kg)
(lbs)
25 to less than 32
55 to less than 70
200
100c
32 to less than 39
70 to less than 86
250
100c
at least 39
at least 86
300
100c
a The recommended dosage of REYATAZ can be achieved using a combination of commercially available capsule strengths.
b The dosage was calculated as REYATAZ 7 mg/kg with ritonavir 4 mg/kg once daily with food not to exceed REYATAZ 300 mg and ritonavir 100 mg.
c Ritonavir capsule or liquid.
In section 6 Adverse Reactions subsection 6.2 Clinical Trial Experience in Pediatric Patients was added and includes the following information:
The safety profile of REYATAZ in pediatric patients (6 to less than 18 years of age) was comparable to that observed in clinical studies of REYATAZ in adults. The most common Grade 2-4 adverse events (≥5%, regardless of causality) reported in pediatric patients were cough (21%), fever (19%), rash (14%), jaundice/scleral icterus (13%), diarrhea (8%), vomiting (8%), headache (7%), and rhinorrhea (6%). Asymptomatic second-degree atrioventricular block was reported in 2% of patients. The most common Grade 3-4 laboratory abnormality was elevation of total bilirubin (≥3.2 mg/dL) which occurred in 49% of pediatric patients. All other Grade 3-4 laboratory abnormalities occurred with a frequency of less than 3%.
In section 14 Clinical Studies, subsection 14.3 Pediatric Patients was added and includes the following:
Assessment of the pharmacokinetics, safety, tolerability, and efficacy of REYATAZ is based on data from the open-label, multicenter clinical trial PACTG 1020A conducted in patients from 3 months to 21 years of age. In this study, 182 patients (83 antiretroviral-naïve and 99 antiretroviral-experienced) received once daily REYATAZ, with or without ritonavir, in combination with two NRTIs.
Ninety-nine patients (6 to less than 18 years of age) treated with the REYATAZ capsule formulation, with or without ritonavir, were evaluated. In this cohort, the overall proportions of antiretroviral-naïve and -experienced patients with HIV RNA <400 copies/mL at week 24 were 68% (28/41) and 33% (19/58), respectively. The overall proportions of antiretroviral-naïve and experienced patients with HIV RNA <50 copies/mL at week 24 were 59% (24/41) and 24% (14/58), respectively. The median increase from baseline in absolute CD4 count at 20 weeks of therapy was 171 cells/mm3 in antiretroviral-naïve patients and 116 cells/mm3 in antiretroviral-experienced patients.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
080326
FD080305
SOURCE: Food and Drug Administration (FDA).
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