INTELENCE- etravirine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETRAVIRINE (UNII: 0C50HW4FO1) (etravirine - UNII:0C50HW4FO1)

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

ETRAVIRINE

Composition:

ETRAVIRINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

INTELENCE - ETRAVIRINE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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.