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These highlights do not include all the information needed to use INTELENCE® safely and effectively. See full prescribing information for INTELENCE®. INTELENCE® (etravirine) [Tablets] Initial U.S. Approval – 2008
Medication labelWhy this: Advisory · dailymed-prescription
INTELENCE® Registered trademark of Tibotec Pharmaceuticals, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents. This indication is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The following points should be considered when initiating therapy with INTELENCE®: Treatment history and, when available, resistance testing, should guide the use of INTELENCE®. The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response. In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs [see Clinical Studies (14) ]. The risks and benefits of INTELENCE® have not been established in pediatric patients or in treatment-naïve adult patients.
- generic_name
- etravirine
- product_names
- Etravirine
- ndc
- 53808-0787, 59676-570, 53808-0787-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en