Edurant Indications/Uses

EDURANT (rilpivirine), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult and pediatric patients 12 years of age and older (and weighing ≥ 35 kg) with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
Pediatrics: Pediatrics (12 to <18 years of age and weighing at least 35 kg): The safety, efficacy and pharmacokinetics of EDURANT has been established in antiretroviral treatment-naïve, HIV-1 infected pediatric subjects 12 to less than 18 years of age and weighing at least 35 kg (see Recommended Dose and Dosage Adjustment: Pediatric Patients: Pediatric (12 to <18 years of age and weighing ≥ 35 kg) under Dosage & Administration, Pharmacology: Pharmacokinetics: Special Populations and Conditions: Pediatrics under Actions, and Pharmacology: Pharmacodynamics: Clinical Trials: Study Results: Treatment-Naïve Pediatric Patients (12 years to less than 18 years of age): Trial TMC278-C213 under Actions).
Pediatrics (<12 years of age): EDURANT is not recommended for patients less than 12 years of age (see Use in Children under Precautions).
Geriatrics: Geriatrics (> 65 years of age): Clinical studies of EDURANT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from adult subjects <65 years of age. EDURANT should be used with caution in this population (see Use in Elderly under Precautions, Recommended Dose and Dosage Adjustment: Geriatric Patients under Dosage & Administration, and Pharmacology: Pharmacokinetics: Special Populations and Conditions: Geriatrics under Actions).