ETRAVIRINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 6 years of age and older [see Microbiology (12.4) and Clinical Studies (14)] . Additional pediatric use information is approved for Janssen Products, LP’s INTELENCE® (etravirine) tablets. However, due to Janssen Products, LP’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to etravirine 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 ma

Product summary:

Etravirine Tablets, 25 mg are supplied as white to off-white, oval shaped, uncoated tablets containing 25 mg of etravirine. Each tablet is debossed with “A56” on one side and score on the other side. They are available as follows: Bottles of 120 with child-resistant closure:                NDC 60219-1720-7 Each bottle contains 2 desiccant pouches. Etravirine Tablets, 100 mg are supplied as white to off-white, oval shaped, uncoated tablets containing 100 mg of etravirine. Each tablet is debossed with “AC75” on one side and plain on the other side. They are available as follows: Bottles of 120 with child-resistant closure:                NDC 60219-1721-7 Each bottle contains 3 desiccant pouches. Etravirine Tablets, 200 mg are supplied as white to off-white, oval shaped, uncoated tablets containing 200 mg of etravirine. Each tablet is debossed with “AC76” on one side and plain on the other side. They are available as follows: Bottles of 60 with child-resistant closure:                  NDC 60219-1722-6 Each bottle contains 3 desiccant pouches. Store etravirine tablets at 20° to 25°C (68° to 77°F); excursions permitted between 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETRAVIRINE- ETRAVIRINE TABLET
AMNEAL PHARMACEUTICALS NY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ETRAVIRINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ETRAVIRINE TABLETS.
ETRAVIRINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Etravirine 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 6 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 (6 years to less than 18 years of age and weighing
at least 16 kg): dosage of
etravirine tablets are based on body weight and should not exceed the
recommended adult dose.
Etravirine 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 REAC