国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ETRAVIRINE (UNII: 0C50HW4FO1) (etravirine - UNII:0C50HW4FO1)
State of Florida DOH Central Pharmacy
ETRAVIRINE
ETRAVIRINE 100 mg
ORAL
PRESCRIPTION DRUG
INTELENCE® 1, 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 IN
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. They are supplied by State of Florida DOH Central Pharmacy as follows: 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.
New Drug Application
INTELENCE - ETRAVIRINE TABLET STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 RECENT MAJOR CHANGES Warnings and Precautions Severe Skin and Hypersensitivity Reactions (5.1) 08/2009 INDICATIONS AND USAGE INTELENCE is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents. (1) In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs. (1) The safety and efficacy of INTELENCE have not been established in pediatric patients or treatment-naïve adult patients. (1) DOSAGE AND ADMINISTRATION 200 mg (two 100 mg tablets) taken twice daily following a meal. (2) DOSAGE FORMS AND STRENGTHS 100 mg tablets (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Severe, potentially life threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, toxic epidermal necrolysis and erythema multiforme. Immediately discontinue treatment if severe hypersensitivity, severe rash or rash with systemic symptoms or liver transaminase elevations develops and monitor clinical status, including liver transaminases closely. (5.1) ADVERSE REACTIONS The most common adverse drug reactions of moderate to severe intensity (≥ 2%) which occurred at a higher rate than placebo are rash and peripheral neuropathy. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TIBOTEC THERAPEUTICS AT 1-877-REACH-TT OR 1-877- 732-2488 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA. 阅读完整的文件