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

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 DISOPROXIL FUMARATE (UNII: OTT9J7900I) (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:

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 below Coadministration of STRIBILD is contraindicated with drugs that are highly dependent on CYP3A for clearance and for whi

Product summary:

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. Store at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (See USP Controlled Room Temperature).

Authorization status:

New Drug Application

Summary of Product characteristics

STRIBILD- ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR
DISOPROXIL FUMARATE TABLET, FILM
COATED
REMEDYREPACK INC.
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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: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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. ( 5.1)
RECENT MAJOR CHANGES
Dosage and Administration
Testing Prior to Initiation and During Treatment with STRIBILD ( 2.1)
08/2018
Not Recommended During Pregnancy ( 2.5)
11/2018
Contraindications ( 4)
11/2018
Warnings and Precautions
New Onset or Worsening Renal Impairment ( 5.2)
08/2018
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 disoproxil fumarate
(TDF), both HIV nucleoside analog reverse
transcriptase inhibitors (HIV NRTI) and 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. (
1, 14)
DOSAGE AND ADMINISTRATION
Testing: Prior to init