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:

A-S Medication Solutions

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 in Table 1 [see Drug Interactions (7.5) and Clinical Pharmacology (12.3)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors

Product summary:

Product: 50090-2279 NDC: 50090-2279-0 30 TABLET in a BOTTLE, PLASTIC

Authorization status:

New Drug Application

Summary of Product characteristics

GENVOYA- ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR
ALAFENAMIDE TABLET
A-S MEDICATION SOLUTIONS
----------
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._
GENVOYA IS NOT APPROVED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS
(HBV) INFECTION. 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
Boxed Warning, Lactic Acidosis/Severe Hepatomegaly with Steatosis_
[removed]_
04/2017
Indications and Usage (1)
09/2017
Dosage and Administration, Testing Prior to Initiation and During
Treatment with
GENVOYA (2.1)
11/2017
Dosage and Administration, Recommended Dosage (2.2)
09/2017
Warnings and Precautions, New Onset or Worsening Renal Impairment
(5.4)
11/2017
Warnings and Precautions, Lactic Acidosis/Severe Hepatomegaly with
Steatosis (5.5)
04/2017
Warnings and Precautions, Fat Redistribution_ [removed]_
04/2017
Warnings and Precautions, Bone Loss and Mineralization Defects
[_removed]_
12/2016
INDICATIONS AND USAGE
GENVOYA is a four-drug combination of elvitegravir, an HIV-1 integrase
strand transfer inhibitor (INSTI), cobicistat, a
CYP3A inhibitor, and emtricitabine 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