ETRAVIRINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carnegie Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Etravirine, 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.

Product summary:

Etravirine 100 mg tablets are supplied as white to off-white, uncoated, oval shaped tablet, debossed "CP112" on one side and plain on other side. Etravirine 200 mg tablets are supplied as white to off-white, uncoated, oval shaped tablet, debossed "CP113" on one side and plain on other side. Etravirine tablets are packaged in bottles in the following configuration: Store etravirine 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETRAVIRINE- ETRAVIRINE TABLET
CARNEGIE PHARMACEUTICALS 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
RECENT MAJOR CHANGES
Indications and Usage (1) 11/2018
Dosage and Administration:
Recommended Dosage During Pregnancy (2.2) 11/2018
Warnings and Precautions:
Severe Skin and Hypersensitivity Reactions (5.1) 07/2019
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug
Interactions (5.2) 11/2018
Immune Reconstitution Syndrome (5.3) 07/2019
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 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
etravirine is 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: 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)