STRIBILD- elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

elvitegravir (UNII: 4GDQ854U53) (elvitegravir - UNII:4GDQ854U53), cobicistat (UNII: LW2E03M5PG) (cobicistat - UNII:LW2E03M5PG), emtricitabine (UNII: G70B4ETF4S) (emtricitabine - UNII:G70B4ETF4S), tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5)

Tilgjengelig fra:

Avera McKennan Hospital

INN (International Name):

elvitegravir

Sammensetning:

elvitegravir 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

STRIBILD® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 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/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 STRIBILD [see Clinical Studies (14)] . Coadministration of STRIBILD 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 STRIBILD 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 exp

Produkt oppsummering:

STRIBILD tablets are green, capsule shaped, film coated, and debossed with "GSI" on one side and the number "1" surrounded by a square box ( ) on the other side. Each bottle contains 30 tablets (NDC 61958-1201-1) and a silica gel desiccant, and is closed with a child-resistant closure. NDC 69189-1201-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Store at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (See USP Controlled Room Temperature).

Autorisasjon status:

New Drug Application

Preparatomtale

STRIBILD- ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR
DISOPROXIL FUMARATE TABLET, FILM
COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STRIBILD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR STRIBILD.
STRIBILD (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, TENOFOVIR
DISOPROXIL FUMARATE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND
POSTTREATMENT
ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH THE
USE OF NUCLEOSIDE ANALOGS, INCLUDING TENOFOVIR DISOPROXIL FUMARATE
(DF), A COMPONENT OF STRIBILD. (5.1)
STRIBILD IS NOT APPROVED FOR THE TREATMENT OF CHRONIC HEPATITIS B
VIRUS (HBV) INFECTION. SEVERE ACUTE
EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS COINFECTED
WITH HIV-1 AND HBV WHO HAVE
DISCONTINUED EMTRIVA OR VIREAD, TWO OF THE COMPONENTS OF STRIBILD.
HEPATIC FUNCTION SHOULD BE
MONITORED CLOSELY IN THESE PATIENTS. IF APPROPRIATE, INITIATION OF
ANTI-HEPATITIS B THERAPY MAY BE
WARRANTED. (5.2)
RECENT MAJOR CHANGES
Indications and Usage (1)
01/2017
Dosage and Administration, Testing Prior to Initiation and During
Treatment with STRIBILD (2.1)
01/2017
Dosage and Administration, Recommended Dosage (2.2)
01/2017
Dosage and Administration, Dosage Adjustment in Patients with Renal
Impairment (2.3)
01/2017
Contraindications (4)
09/2016
Warnings and Precautions, New Onset or Worsening Renal Impairment
(5.3)
01/2017
Warnings and Precautions, Avoid Use with Other Antiretroviral Products
(5.4)
Removed 01/2017
Warnings and Precautions, Bone Loss and Mineralization Defects (5.5)
01/2017
INDICATIONS AND USAGE
STRIBILD is a four-drug combination of elvitegravir, an HIV integrase
strand transfer inhibitor (HIV-1 INSTI), cobicistat, a
CYP3A inhibitor, and emtricitabine and tenofovir DF, bot