Efficacy and safety of Reyataz with ritonavir in doses >100 mg once daily have not been established. The use of higher ritonavir doses might alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended.
Recommended Dosage: Treatment-Naive Patients: 400 mg once daily taken with food, or 300 mg once daily with ritonavir 100 mg once daily taken with food.
Treatment-Experienced Patients: 300 mg once daily with ritonavir 100 mg once daily taken with food.
Reyataz without ritonavir is not recommended for treatment-experienced patients with prior virologic failure.
Concomitant Therapy: Didanosine: It is recommended that all didanosine formulations be administered on an empty stomach and that Reyataz be taken with food; therefore, didanosine should be taken 2 hrs after Reyataz (taken with food).
Tenofovir: When co-administered with tenofovir, it is recommended that Reyataz 300 mg be given with ritonavir 100 mg and tenofovir 300 mg, all as a single daily dose with food. Reyataz without ritonavir should not be co-administered with tenofovir.
Adolescents and Children: The optimal dosing regimen for use of Reyataz in pediatric patients has not been established. Reyataz should not be administered to pediatric patients <3 months.
Elderly: Clinical studies of Reyataz did not include sufficient numbers of patients ≥65 years to determine whether they respond differently than younger patients. Based on pharmacokinetic comparisons, a dose adjustment for age is not recommended.
Renal Impairment: For patients with renal impairment, including those with severe renal impairment who are not managed by hemodialysis, no dose adjustment is required for Reyataz. For treatment-naive patients managed with hemodialysis, administration of Reyataz 300 mg with ritonavir 100 mg is recommended. Reyataz should not be administered to HIV-treatment-experienced patients with severe renal impairment managed with hemodialysis.
Hepatic Impairment: Reyataz should be used with caution in patients with mild to moderate hepatic impairment. A dose reduction to 300 mg once daily should be considered for patients with moderate hepatic impairment. Reyataz should not be used in patients with severe hepatic impairment. Reyataz in combination with ritonavir has not been studied in subjects with hepatic impairment and should be used with caution in patients with mild hepatic impairment. Reyataz with ritonavir is not recommended for patients with moderate to severe impairment.