INDICATIONS AND USAGE
INTELENCE™, 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 24 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 ].
- The risks and benefits of INTELENCE™ have not been established in pediatric patients or in treatment-naive adult patients.
DOSAGE AND ADMINISTRATION
The recommended oral dose of INTELENCE™ tablets is 200 mg (two 100 mg tablets) taken twice daily following a meal [ see Clinical Pharmacology ]. The type of food does not affect the exposure to etravirine. Patients who are unable to swallow INTELENCE™ tablets whole may disperse the tablets in a glass of water. Once dispersed, patients should stir the dispersion well and drink it immediately. The glass should be rinsed with water several times and each rinse completely swallowed to ensure the entire dose is consumed.
DOSAGE FORMS AND STRENGTHS
100 mg white to off-white oval tablets debossed with "TMC125" on one side and "100" on the other side.
HOW SUPPLIED/STORAGE AND HANDLING
INTELENCE™ tablets are supplied as white to off-white, oval tablets containing 100 mg of etravirine. Each tablet is debossed with "TMC125" on one side and "100" on the other side.
INTELENCE™ tablets are packaged in bottles in the following configuration: 100 mg tabletsâ€”bottles of 120 (NDC 59676-570-01). Each bottle contains 3 desiccant pouches.
Store INTELENCE™ tablets at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant pouches.