GENVOYA- elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ELVITEGRAVIR (UNII: 4GDQ854U53) (ELVITEGRAVIR - UNII:4GDQ854U53), COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG), EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S), TENOFOVIR ALAFENAMIDE FUMARATE (UNII: FWF6Q91TZO) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Available from:

REMEDYREPACK INC.

INN (International Name):

ELVITEGRAVIR

Composition:

ELVITEGRAVIR 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA [see Clinical Studies (14)]. Coadministration of GENVOYA is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of GENVOYA and possible resistance) are listed below [see Drug Interactions (7.5) and Clinical Pharmacology (12.3)]

Product summary:

GENVOYA tablets each contain 150 mg of elvitegravir (EVG), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF). These tablets are green, capsule-shaped, film-coated, debossed with "GSI" on one side of the tablet and the number "510" on the other side NDC: 70518-0568-00 PACKAGING: 30 in 1 BLISTER PACK Store below 30 °C (86 °F). Keep container tightly closed. Dispense only in original container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application

Summary of Product characteristics

GENVOYA- ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR
ALAFENAMIDE TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GENVOYA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GENVOYA.
GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE)
TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2015
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE
COINFECTED WITH HIV-1 AND HBV AND HAVE DISCONTINUED PRODUCTS
CONTAINING
EMTRICITABINE AND/OR TENOFOVIR DISOPROXIL FUMARATE (TDF), AND MAY
OCCUR WITH
DISCONTINUATION OF GENVOYA. HEPATIC FUNCTION SHOULD BE MONITORED
CLOSELY IN THESE
PATIENTS. IF APPROPRIATE, ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. (
5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, New Onset or Worsening Renal Impairment (
5.4)
03/2021
INDICATIONS AND USAGE
GENVOYA is a four-drug combination of elvitegravir (EVG), an HIV-1
integrase strand transfer inhibitor
(INSTI), cobicistat (COBI), a CYP3A inhibitor, and emtricitabine (FTC)
and tenofovir alafenamide (TAF), both
HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and
is indicated as a complete regimen
for the treatment of HIV-1 infection in adults and pediatric patients
weighing at least 25 kg who have no
antiretroviral treatment history or to replace the current
antiretroviral regimen in those who are
virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a
stable antiretroviral regimen for at
least 6 months with no history of treatment failure and no known
substitutions associated with resistance
to the individual components of GENVOYA. ( 1)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating GENVOYA test for hepatitis B
virus infection. Prior to or when initiating
GENVOYA, and during treatment on a clinically appropriate schedule,
assess se