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">Entrectinib is a kinase inhibitor. The molecular formula for entrectinib is C<span class="Sub">31</span>H<span class="Sub">34</span>F<span class="Sub">2</span>N<span class="Sub">6</span>O<span class="Sub">2</span> and the molecular weight is 560.64 Daltons. The chemical name is N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide. The chemical structure of entrectinib is as follows:</p><p><img alt="Chemical Structure" src="rozlytrek-01.jpg"/></p><p>Entrectinib is white to pale pink powder.</p><div class="Section" data-sectioncode="42229-5"><a name="section-9.1"></a><p></p><p class="First"><span class="Underline">Capsules:</span></p><p>ROZLYTREK (entrectinib) capsules for oral use are supplied as printed hard-shell capsules containing 100 mg (yellow opaque HPMC capsule) or 200 mg of entrectinib (orange opaque HPMC capsule). Inactive ingredients are tartaric acid, lactose anhydrous, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.</p><p>The yellow opaque capsule shell contains hypromellose, titanium dioxide, and yellow iron oxide. The orange opaque capsule shell contains hypromellose, titanium dioxide, and FD&amp;C yellow #6. The printing ink contains shellac, propylene glycol, strong ammonia solution, and FD&amp;C blue #2 aluminum lake.</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-9.2"></a><p></p><p class="First"><span class="Underline">Pellets:</span></p><p>ROZLYTREK (entrectinib) oral pellets are supplied as brownish orange or grayish orange, round film-coated pellets in packets. Each packet contains 50 mg of entrectinib and the following inactive ingredients: tartaric acid, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, sodium stearyl fumarate, mannitol, and magnesium stearate.</p><p>The film-coating contains polyvinyl alcohol (partially hydrolyzed), titanium dioxide, polyethylene glycol 3350, talc, yellow iron oxide, red iron oxide, and ferrosoferric oxide.</p></div></section>

Rozlytrek

entrectinib

entrectinib 100 MG Oral Capsule

entrectinib 100 MG Oral Capsule [Rozlytrek]

entrectinib 200 MG Oral Capsule

entrectinib 200 MG Oral Capsule [Rozlytrek]

entrectinib 50 MG Oral Pellet

entrectinib 50 MG Oral Pellet [Rozlytrek]

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