COMPLERA- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

emtricitabine (UNII: G70B4ETF4S) (emtricitabine - UNII:G70B4ETF4S), rilpivirine hydrochloride (UNII: 212WAX8KDD) (rilpivirine - UNII:FI96A8X663), tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5)

थमां उपलब्ध:

Gilead Sciences, Inc.

INN (इंटरनेशनल नाम):

emtricitabine

रचना:

emtricitabine 200 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

COMPLERA® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: - as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or - to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA [see Microbiology (12.4) and Clinical Studies (14)] . Limitations of Use : - More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14)] . COMPLERA is contraindicated when coadministered with the following

उत्पाद समीक्षा:

COMPLERA tablets are purplish pink, capsule shaped, film coated, debossed with "GSI" on one side, and plain faced on the other side. Each bottle contains 30 tablets (NDC 61958-1101-1), a silica gel desiccant, and a polyester fiber coil, and is closed with a child-resistant closure. Store at 25 °C (77 °F), excursions permitted to 15 °C–30 °C (59 °F–86 °F) [See USP Controlled Room Temperature]. Keep container tightly closed. Dispense only in original container.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

COMPLERA- EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR
DISOPROXIL
FUMARATE TABLET, FILM COATED
GILEAD SCIENCES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COMPLERA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COMPLERA.
COMPLERA (EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE)
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B VIRUS (HBV) HAVE BEEN
REPORTED IN PATIENTS
COINFECTED WITH HIV-1 AND HBV WHO HAVE DISCONTINUED PRODUCTS
CONTAINING
EMTRICITABINE (FTC) AND/OR TENOFOVIR DISOPROXIL FUMARATE (TDF), TWO OF
THE COMPONENTS
OF COMPLERA. CLOSELY MONITOR HEPATIC FUNCTION WITH BOTH CLINICAL AND
LABORATORY FOLLOW-
UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO ARE COINFECTED WITH
HIV-1 AND HBV AND
DISCONTINUE COMPLERA. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B
THERAPY MAY BE
WARRANTED. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions
Immune Reconstitution Syndrome (5.9)
11/2019
INDICATIONS AND USAGE
COMPLERA, a combination of two nucleoside analog HIV-1 reverse
transcriptase inhibitors (emtricitabine
and tenofovir disoproxil fumarate) and one non-nucleoside reverse
transcriptase inhibitor (rilpivirine), is
indicated for use as a complete regimen for the treatment of HIV-1
infection in patients weighing at least
35 kg (1) as initial therapy in those with no antiretroviral treatment
history and with HIV-1 RNA less than or
equal to 100,000 copies/mL at the start of therapy, or (2) or to
replace a stable antiretroviral regiment in
those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a
stable antiretroviral regimen for at
least 6 months with no treatment failure and no known substitutions
associated with resistance to the
individual components of COMPLERA. (1, 14)
Limitations of Use:
More rilpivirine-treated subjects with HIV-1 R