Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
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)
Avera McKennan Hospital
elvitegravir
elvitegravir 150 mg
ORAL
PRESCRIPTION DRUG
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
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).
New Drug Application
STRIBILD- ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED AVERA MCKENNAN HOSPITAL ---------- 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 Lugege kogu dokumenti