INTELENCE- etravirine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Janssen Products LP

INN (International Name):

etravirine

Composition:

etravirine 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 and pediatric patients 2 years of age and older [see Microbiology (12.4)and Clinical Studies (14)] . None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to INTELENCE during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Prospective pregnancy data from clinical trials and the APR are not sufficient to adequately assess the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Etravirine use during pregnancy has been evaluated in a limited number of individuals as reported by the APR, and available data show 1 birth defect in 66 first trimester exposures to etravirine-containing regim

Product summary:

INTELENCE ® (etravirine) 25 mg tablets are supplied as white to off-white, oval, scored tablets containing 25 mg of etravirine. Each tablet is debossed with "TMC" on one side. INTELENCE ® (etravirine) 100 mg 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 ® (etravirine) 200 mg tablets are supplied as white to off-white, biconvex, oblong tablets containing 200 mg of etravirine. Each tablet is debossed with "T200" on one side. INTELENCE tablets are packaged in bottles in the following configuration: Store INTELENCE tablets at 25°C (77°F); with excursions permitted to 15° to 30°C (59° to 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. Keep INTELENCE and all medicines out of the reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

INTELENCE- ETRAVIRINE TABLET
JANSSEN PRODUCTS LP
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
INTELENCE is a human immunodeficiency virus type 1 (HIV-1)
non-nucleoside reverse transcriptase
inhibitor (NNRTI) indicated for treatment of HIV-1 infection in
treatment-experienced patients 2 years of
age and older. ( 1)
DOSAGE AND ADMINISTRATION
Adult patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken
twice daily following a meal. (
2.1, 2.2, 2.4)
Pregnant patients: 200 mg (one 200 mg tablet or two 100 mg tablets)
taken twice daily following a
meal. ( 2.2)
Pediatric patients (2 years to less than 18 years of age and weighing
at least 10 kg): dosage of
INTELENCE is based on body weight and should not exceed the
recommended adult dose. INTELENCE
tablets should be taken following a meal. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 100 mg, and 200 mg ( 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)
Monitor for immune reconstitution syndrome and fat redistribution. (
5.3, 5.4)
ADVERSE REACTIONS
The most common adverse drug reactions of moderate to severe intensity
(at least 2%) which occurred at
a higher rate than placebo in adults are rash and peripheral
neuropathy. ( 6.1)
The most common adverse drug reactions in at least 2% of pediatric
patients are rash and diarrhea. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JANSS