STRIBILD (Emtricitabine, Tenofovir Disoproxil, Elvitegravir And Cobicistat)

STRIBILD (Elvitegravir, emtricitabine and tenofovir are antiviral drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in the body. HIV causes acquired immunodeficiency syndrome (AIDS).

Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses.

Stribild (cobicistat, elvitegravir, emtricitabine, and tenofovir) is a combination medicine used to treat HIV in adults who have never taken HIV medicines before. Stribild is not a cure for HIV or AIDS.

Stribild may also be used for purposes not listed in this medication guide.

Each film-coated tablet contains elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (tenofovir DF equivalent to tenofovir disoproxil 245 mg).

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. Emtricitabine is a synthetic nucleoside analog of cytidine. Emtriva is the brand name for emtricitabine. Tenofovir DF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Viread is the brand name for tenofovir DF.

Elvitegravir: The chemical name of elvitegravir is 6-(3-Chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.

It has a molecular formula of C₂₃H₂₃ClFNO₅ and a molecular weight of 447.9.

Elvitegravir is a white to pale yellow powder with a solubility of <0.3 mcg per mL in water at 20°C.

Cobicistat: The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl [(2R,5R)-5-{[(2S)-2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate.

It has a molecular formula of C₄₀H₅₃N₇O₅S₂ and a molecular weight of 776.0.

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.

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 bis-isopropoxycarbonyloxymethyl 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.

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 noted.

Excipients/Inactive Ingredients: Lactose monohydrate, microcrystalline cellulose, silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate and magnesium stearate. Film-coating: Polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.