STRIBILD is a fixed-dose combination tablet containing
elvitegravir, cobicistat, emtricitabine, and tenofovir DF. Elvitegravir is a HIV-1
integrase strand transfer inhibitor. Cobicistat is a mechanism-based inhibitor
of cytochrome P450 (CYP) enzymes of the CYP3A family. Tenofovir DF is converted
in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of
VIREAD is the brand name for tenofovir DF. Emtricitabine is a synthetic
nucleoside analog of cytidine. EMTRIVA is the brand name for emtricitabine.
STRIBILD tablets are for oral administration. Each tablet
contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine,
and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil). The
tablets include the following inactive ingredients: lactose monohydrate,
microcrystalline cellulose, silicon dioxide, croscarmellose sodium,
hydroxypropyl cellulose, sodium lauryl sulfate, and magnesium stearate. The
tablets are film-coated with a coating material containing indigo carmine
(FD&C Blue #2) aluminum lake, polyethylene glycol, polyvinyl alcohol, talc,
titanium dioxide, and yellow iron oxide.
Elvitegravir: The chemical name of elvitegravir is
It has a molecular formula of C23H23ClFNO5
and a molecular weight of 447.9. It has the following structural formula:
Elvitegravir is a white to pale
yellow powder with a solubility of less than 0.3 micrograms per mL in water at
Cobicistat: The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl
It has a molecular formula of C40H53N7O5S2
and a molecular weight of 776.0. It has the following structural formula:
Cobicistat is adsorbed onto
silicon dioxide. Cobicistat on silicon dioxide is a white to pale yellow solid
with a solubility of 0.1 mg per mL in water at 20 °C.
Emtricitabine: The chemical name of emtricitabine is 5-fluoro-1-[(2R,5S)-2(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine.
Emtricitabine is the (-)enantiomer of a thio analog of cytidine, which differs
from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of C8H10FN3O3S
and a molecular weight of 247.25. It has the following structural formula:
Emtricitabine is a white to
off-white crystalline powder with a solubility of approximately 112 mg per mL
in water at 25 °C.
Tenofovir Disoproxil Fumarate: Tenofovir DF is a fumaric acid salt of the
bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name
of tenofovir DF is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine
fumarate (1:1). It has a molecular formula of C19H30N5O10P
•C4H4O4 and a molecular weight of 635.51. It
has the following structural formula:
Tenofovir DF is a white to
off-white crystalline powder with a solubility of 13.4 mg per mL in water at 25
°C. All dosages are expressed in terms of tenofovir DF except where otherwise
Last reviewed on RxList: 9/20/2012
This monograph has been modified to include the generic and brand name in many instances.