<section class="Section" data-sectioncode="34089-3"><a name="LINK_611d4771-5847-4d66-aca8-3dd6bd027ea5"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">SYNRIBO contains the active ingredient omacetaxine mepesuccinate, a cephalotaxine ester.  It is a protein synthesis inhibitor.  Omacetaxine mepesuccinate is prepared by a semi-synthetic process from cephalotaxine, an extract from the leaves of <span class="Italics">Cephalotaxus sp</span>.  The chemical name of omacetaxine mepesuccinate is cephalotaxine, 4-methyl (2<span class="Italics">R</span>)-hydroxyl-2-(4-hydroxyl-4-methylpentyl) butanedioate (ester).  </p><p>Omacetaxine mepesuccinate has the following chemical structure:  </p><div class="Figure"><img alt="Chemical Structure" src="image-1.jpg"/></div><p>The molecular formula is C<span class="Sub">29</span>H<span class="Sub">39</span>NO<span class="Sub">9</span> with a molecular weight of 545.6 g/mol.  SYNRIBO for Injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial.  Each vial contains 3.5 mg omacetaxine mepesuccinate, 60 mg hydrochloric acid for drug substance solubilization, 10 mg mannitol as a bulking agent, and hydrochloric acid and sodium bicarbonate to adjust pH to 6.  </p><p>SYNRIBO is intended for subcutaneous administration after reconstitution with 1.0 mL of 0.9% Sodium Chloride Injection, USP.  The pH of the reconstituted solution is between 5.5 and 7.0.  </p></section>

SYNRIBO

omacetaxine mepesuccinate 3.5 MG Injection

Synribo

omacetaxine mepesuccinate 3.5 MG Injection [Synribo]

omacetaxine mepesuccinate

Psoriasis (PsO)

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Taltz

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Prescribing Information

Instructions For Use: Chronic or Accelerated Phase Chronic Myeloid Leukemia (CML)