; 7bit You are receiving this message as a buy onliner to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment. *Please do not reply to this message.* 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) pediatric patients with body weight less than 25 kg. "Therapy-Naive Pediatric Patients" The recommended dosage of REYATAZ with ritonavir in treatment-naive patients at least 6 years of age is shown in Table 1. For treatment-naive 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-Naive 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) 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. Pediatric Patients" The recommended dosage of REYATAZ with ritonavir in patients at least 6 years of age is shown in Table 2. Table 2: Dosage for 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 (^35%, regardless of causality) reported in pediatric patients were cough (21%), fever (19%), rash (14%), icterus (13%), diarrhea (8%), vomiting (8%), headache (7%), and rhinorrhea (6%). Asymptomatic second-degree block was reported in 2% of patients. The most common Grade 3-4 laboratory abnormality was elevation of total bilirubin (^33.2 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 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 and 99 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 and -experienced patients with HIV RNA =09 =09 =09 Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Buy onliner Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). =09 =09=09 =09 =09 =09 =09 =09=09 Inc. sending on behalf of U.S. Food & Drug Administration (FDA) 5600 Fishers Lane =09=09=09 Rockville MD 20857 800-439-1420 =09=09 =09 =09 ;

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