Kinase Inhibitor

Rearranged during Transfection (RET) Inhibitors

Carcinoma, Non-Small-Cell Lung

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (<span class="Italics">cis</span>)-<span class="Italics">N</span>-((<span class="Italics">S</span>)-1-(6-(4-fluoro-1<span class="Italics">H</span>-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1<span class="Italics">H</span>-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide. The molecular formula for pralsetinib is C<span class="Sub">27</span>H<span class="Sub">32</span>FN<span class="Sub">9</span>O<span class="Sub">2</span>, and the molecular weight is 533.61 g/mol. Pralsetinib has the following structure:</p><div class="Figure"><img alt="Chemical Structure" src="gavreto-01.jpg"/></div><p>The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to &lt; 0.001 mg/mL, indicating a decrease in solubility with increasing pH.</p><p>GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients:</p><p>citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&amp;C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.</p></section>

Gavreto

pralsetinib

pralsetinib 100 MG Oral Capsule

pralsetinib 100 MG Oral Capsule [Gavreto]

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