Cytochrome P450 3A Inhibitors

Kinase Inhibitor

Kinase Inhibitors

Breast Neoplasms

<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">IBRANCE tablets for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor. The molecular formula for palbociclib is C<span class="Sub">24</span>H<span class="Sub">29</span>N<span class="Sub">7</span>O<span class="Sub">2</span>. The molecular weight is 447.54 daltons. The chemical name is 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-<span class="Italics">d</span>]pyrimidin-7(8<span class="Italics">H</span>)-one, and its structural formula is: </p><div class="Figure"><img alt="Chemical Structure" src="ibrance-01.jpg"/></div><p>Palbociclib is a yellow to orange powder. At or below pH 4, palbociclib behaves as a high-solubility compound. Above pH 4, the solubility of the drug substance reduces significantly.</p><p><span class="Italics">Inactive Ingredients:</span> Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, succinic acid, HPMC 2910/hypromellose, titanium dioxide, triacetin, and FD&amp;C Blue #2/Indigo Carmine Aluminum Lake. In addition, the 75 mg and 125 mg tablets contain red iron oxide and the 100 mg tablets contain yellow iron oxide. </p></section>

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