Kinase Inhibitor

Tropomyosin Receptor Kinases Inhibitors

Neoplasm Metastasis

<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">Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C<span class="Sub">21</span>H<span class="Sub">24</span>F<span class="Sub">2</span>N<span class="Sub">6</span>O<span class="Sub">6</span>S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3<span class="Italics">S</span>)-<span class="Italics">N</span>-{5-[(2<span class="Italics">R</span>)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure:</p><div class="Figure"><a name="m1"></a><img alt="image of the chemical structure of VITRAKVI" src="chem-struct.jpg"/></div><p>Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37ᴼC is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). </p><p>VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. </p><p>The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate.</p><p>The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.</p></section>

VITRAKVI

larotrectinib

larotrectinib 100 MG Oral Capsule

Vitrakvi

larotrectinib 100 MG Oral Capsule [Vitrakvi]

larotrectinib 20 MG/ML Oral Solution

larotrectinib 20 MG/ML Oral Solution [Vitrakvi]

larotrectinib 25 MG Oral Capsule

larotrectinib 25 MG Oral Capsule [Vitrakvi]

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