Chloride Channel Activation Potentiators

Cystic Fibrosis Transmembrane Conductance Regulator Potentiator

P-Glycoprotein Inhibitors

Cytochrome P450 2C9 Inhibitors

Cytochrome P450 3A Inhibitors

Cytochrome P450 2C9 Inducers

Cytochrome P450 2C19 Inducers

Cytochrome P450 2C8 Inhibitors

Cytochrome P450 2C8 Inducers

Cytochrome P450 2B6 Inducers

Cytochrome P450 3A Inducers

P-Glycoprotein Inducers

Cystic Fibrosis

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">The active ingredients in ORKAMBI tablets are lumacaftor, which has the following chemical name: 3-[6-({[1-(2,2-difluoro-1,3-benzodioxol-5-yl)cyclopropyl]carbonyl}amino)-3-methylpyridin-2-yl]benzoic acid, and ivacaftor, a <span class="Italics">CFTR</span> potentiator, which has the following chemical name: <span class="Italics">N</span>-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide. The molecular formula for lumacaftor is C<span class="Sub">24</span>H<span class="Sub">18</span>F<span class="Sub">2</span>N<span class="Sub">2</span>O<span class="Sub">5</span> and for ivacaftor is C<span class="Sub">24</span>H<span class="Sub">28</span>N<span class="Sub">2</span>O<span class="Sub">3</span>. The molecular weights for lumacaftor and ivacaftor are 452.41 and 392.49, respectively. The structural formulas are:</p><div class="Figure"><img alt="Chemical Structure" src="orkambi-01.jpg"/><p class="MultiMediaCaption">lumacaftor</p></div><div class="Figure"><img alt="Chemical Structure" src="orkambi-02.jpg"/><p class="MultiMediaCaption">ivacaftor</p></div><p>Lumacaftor is a white to off-white powder that is practically insoluble in water (0.02 mg/mL). Ivacaftor is a white to off-white powder that is practically insoluble in water (&lt;0.05 µg/mL).</p><p>ORKAMBI is available as a pink, oval-shaped, film-coated tablet for oral administration containing 200 mg of lumacaftor and 125 mg of ivacaftor. Each ORKAMBI tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor, and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; povidone; and sodium lauryl sulfate. The tablet film coat contains carmine, FD&amp;C Blue #1, FD&amp;C Blue #2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac.</p><p>ORKAMBI is also available as a pink, oval-shaped, film-coated tablet for oral administration containing 100 mg of lumacaftor and 125 mg of ivacaftor. Each ORKAMBI tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor, and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; povidone; and sodium lauryl sulfate. The tablet film coat contains carmine, FD&amp;C Blue #1, FD&amp;C Blue #2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac.</p><p>ORKAMBI is also available as white to off-white granules for oral administration and enclosed in a unit-dose packet containing lumacaftor 75 mg/ivacaftor 94 mg, lumacaftor 100 mg/ivacaftor 125 mg or lumacaftor 150 mg/ivacaftor 188 mg per packet. Each unit-dose packet of ORKAMBI oral granules contains lumacaftor 75 mg/ivacaftor 94 mg, lumacaftor 100 mg/ivacaftor 125 mg or lumacaftor 150 mg/ivacaftor 188 mg per packet and the following inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone; and sodium lauryl sulfate.</p></section>

ORKAMBI

ivacaftor

lumacaftor

ivacaftor / lumacaftor

ivacaftor 125 MG / lumacaftor 200 MG Oral Tablet

ivacaftor 125 MG / lumacaftor 200 MG Oral Tablet [ORKAMBI]

ivacaftor 125 MG / lumacaftor 100 MG Oral Tablet

ivacaftor 125 MG / lumacaftor 100 MG Oral Tablet [ORKAMBI]

ivacaftor 125 MG / lumacaftor 100 MG Oral Granules

ivacaftor 125 MG / lumacaftor 100 MG Oral Granules [ORKAMBI]

ivacaftor 188 MG / lumacaftor 150 MG Oral Granules

ivacaftor 188 MG / lumacaftor 150 MG Oral Granules [ORKAMBI]

ivacaftor 94 MG / lumacaftor 75 MG Oral Granules

ivacaftor 94 MG / lumacaftor 75 MG Oral Granules [ORKAMBI]

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