Chloride Channel Activation Potentiators

Cystic Fibrosis Transmembrane Conductance Regulator Potentiator

Cytochrome P450 2C9 Inhibitors

Cytochrome P450 3A Inhibitors

Cytochrome P450 3A4 Inhibitors

P-Glycoprotein Inhibitors

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">TRIKAFTA is a co-package of elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets and ivacaftor tablets. Both tablets are for oral administration.</p><p>The elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets are available as: orange, capsule-shaped, film-coated tablet containing 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor, or light-orange, capsule-shaped, film-coated tablet containing 50 mg of elexacaftor, 25 mg of tezacaftor, 37.5 mg of ivacaftor. The fixed-dose combination tablet contains the following inactive ingredients: hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, croscarmellose sodium, microcrystalline cellulose and magnesium stearate. The tablet film coat contains hypromellose, hydroxypropyl cellulose, titanium dioxide, talc, iron oxide yellow and iron oxide red.</p><p>The ivacaftor tablet is available as a light blue, capsule-shaped, film-coated tablet containing 150 mg or 75 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The tablet film coat contains carnauba wax, FD&amp;C Blue #2, PEG 3350, polyvinyl alcohol, talc and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac.</p><p>The active ingredients of TRIKAFTA are described below.</p><div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a><p></p><p class="First"><span class="Underline">Elexacaftor</span></p><p>Elexacaftor is a white solid that is practically insoluble in water (&lt;1 mg/mL). Its chemical name is N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide. Its molecular formula is C<span class="Sub">26</span>H<span class="Sub">34</span>N<span class="Sub">7</span>O<span class="Sub">4</span>SF<span class="Sub">3</span> and its molecular weight is 597.66. Elexacaftor has the following structural formula:</p><div class="Figure"><img alt="Chemical Structure" src="trikafta-01.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a><p></p><p class="First"><span class="Underline">Tezacaftor</span></p><p>Tezacaftor is a white to off-white solid that is practically insoluble in water (&lt;5 microgram/mL). Its chemical name is 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide. Its molecular formula is C<span class="Sub">26</span>H<span class="Sub">27</span>N<span class="Sub">2</span>F<span class="Sub">3</span>O<span class="Sub">6</span> and its molecular weight is 520.50. Tezacaftor has the following structural formula:</p><div class="Figure"><img alt="Chemical Structure" src="trikafta-02.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a><p></p><p class="First"><span class="Underline">Ivacaftor</span></p><p>Ivacaftor is a white to off-white crystalline solid that is practically insoluble in water (&lt;0.05 microgram/mL). Pharmacologically it is a CFTR potentiator. Its chemical name is <span class="Italics">N</span>-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide. Its molecular formula 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> and its molecular weight is 392.49. Ivacaftor has the following structural formula:</p><div class="Figure"><img alt="Chemical Structure" src="trikafta-03.jpg"/></div></div></section>

Trikafta

elexacaftor

elexacaftor / ivacaftor / tezacaftor

elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet

elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet

ivacaftor

ivacaftor 150 MG Oral Tablet

ivacaftor 75 MG Oral Tablet

tezacaftor

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Instructions For Use: Cystic Fibrosis 

Age	Morning Dose	Evening Dose
6 to less than 12 years weighing less than 30 kgs	Two tablets, each containing elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg	One tablet of ivacaftor 75 mg
6 to less than 12 years weighing 30 kgs or more	Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg	One tablet of ivacaftor 150 mg
12 years and older	Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg	One tablet of ivacaftor 150 mg

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