Radioligand Activity

Radioligand Therapeutic Agent

Prostatic Neoplasms

<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">PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent. Lutetium Lu 177 vipivotide tetraxetan is a PSMA-binding ligand bound to a DOTA chelator radiolabeled with lutetium-177.</p><p>The chemical name is 2-[4-[2-[[4-[[(2S)-1-[[(5S)-5-carboxy-5-[[(1S)-1,3-dicarboxy propyl]carbamoylamino]pentyl]amino]-3-naphthalen-2-yl-1-oxopropan-2-yl]carbamoyl]cyclohexyl]methylamino]-2-oxoethyl]-4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetate; lutetium-177(3+). The molecular mass is 1216.06 g/mol and the molecular formula is C<span class="Sub">49</span>H<span class="Sub">68</span><span class="Sup">177</span>LuN<span class="Sub">9</span>O<span class="Sub">16</span>. The chemical structure for lutetium Lu 177 vipivotide tetraxetan is shown below:</p><div class="Figure"><img alt="Chemical Structure of lutetium" src="psma617-01.jpg"/></div><p>PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) 1,000 MBq/mL (27 mCi/mL) Injection is supplied as a sterile, clear, colorless to slightly yellow solution for intravenous use. Each single-dose vial contains acetic acid (0.30 mg/mL), sodium acetate (0.41 mg/mL), gentisic acid (0.39 mg/mL), sodium ascorbate (50.0 mg/mL), pentetic acid (0.10 mg/mL), and water for injection (q.s. to 1 mL). The pH range of the solution is 4.5 to 7.0.</p><div class="Section" data-sectioncode="42229-5"><a name="s11p1"></a><a name="section-9.1"></a><p></p><h2>11.1     Physical Characteristics</h2><p class="First">Lutetium-177 decays to a stable hafnium-177 with a physical half-life of 6.647 days by emitting beta-minus radiation with a maximum energy of 0.498 MeV (79%) and photonic radiation (γ) of 0.208 MeV (11%) and 0.113 MeV (6.4%).</p><p>The main radiations of lutetium-177 are detailed in Table 5.</p><table width="50%"><caption><span>Table 5: Lutetium-177 Main Radiations</span></caption><col align="center" width="25%"/><col align="center" width="25%"/><col align="center" width="25%"/><col align="center" width="25%"/><tbody class="Headless"><tr class="First"><td align="center" class="Botrule Lrule Rrule"><span class="Bold">Radiation</span></td><td align="center" class="Botrule Lrule Rrule"><span class="Bold">Energy (keV)</span></td><td align="center" class="Botrule Lrule Rrule"><span class="Bold">Iβ<span class="Sup">-</span>%</span></td><td align="center" class="Botrule Lrule Rrule"><span class="Bold">Iγ%</span></td></tr><tr><td align="center" class="Botrule Lrule Rrule">β<span class="Sup">-</span></td><td align="center" class="Botrule Lrule Rrule">176.5</td><td align="center" class="Botrule Lrule Rrule">12.2</td><td align="center" class="Botrule Lrule Rrule"></td></tr><tr><td align="center" class="Botrule Lrule Rrule">β<span class="Sup">-</span></td><td align="center" class="Botrule Lrule Rrule">248.1</td><td align="center" class="Botrule Lrule Rrule">0.05</td><td align="center" class="Botrule Lrule Rrule"></td></tr><tr><td align="center" class="Botrule Lrule Rrule">β<span class="Sup">-</span></td><td align="center" class="Botrule Lrule Rrule">384.9</td><td align="center" class="Botrule Lrule Rrule">9.1</td><td align="center" class="Botrule Lrule Rrule"></td></tr><tr><td align="center" class="Botrule Lrule Rrule">β<span class="Sup">-</span></td><td align="center" class="Botrule Lrule Rrule">497.8</td><td align="center" class="Botrule Lrule Rrule">78.6</td><td align="center" class="Botrule Lrule Rrule"></td></tr><tr><td align="center" class="Botrule Lrule Rrule">γ</td><td align="center" class="Botrule Lrule Rrule">71.6</td><td align="center" class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule">0.15</td></tr><tr><td align="center" class="Botrule Lrule Rrule">γ</td><td align="center" class="Botrule Lrule Rrule">112.9</td><td align="center" class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule">6.40</td></tr><tr><td align="center" class="Botrule Lrule Rrule">γ</td><td align="center" class="Botrule Lrule Rrule">136.7</td><td align="center" class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule">0.05</td></tr><tr><td align="center" class="Botrule Lrule Rrule">γ</td><td align="center" class="Botrule Lrule Rrule">208.4</td><td align="center" class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule">11.0</td></tr><tr><td align="center" class="Botrule Lrule Rrule">γ</td><td align="center" class="Botrule Lrule Rrule">249.7</td><td align="center" class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule">0.21</td></tr><tr class="Last"><td align="center" class="Botrule Lrule Rrule">γ</td><td align="center" class="Botrule Lrule Rrule">321.3</td><td align="center" class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule">0.22</td></tr></tbody></table></div><div class="Section" data-sectioncode="42229-5"><a name="s11p2"></a><a name="section-9.2"></a><p></p><h2>11.2     External Radiation</h2><p class="First">Table 6 summarizes the radioactive decay properties of lutetium-177.</p><table width="50%"><caption><span>Table 6: Physical Decay Chart: Lutetium-177 Physical Half-life = 6.647 days</span></caption><col align="center" width="50%"/><col align="center" width="50%"/><tbody class="Headless"><tr class="First"><td align="center" class="Botrule Lrule Rrule"><span class="Bold">Hours</span></td><td align="center" class="Botrule Lrule Rrule"><span class="Bold">Fraction remaining</span></td></tr><tr><td align="center" class="Botrule Lrule Rrule">0</td><td align="center" class="Botrule Lrule Rrule">1.000</td></tr><tr><td align="center" class="Botrule Lrule Rrule">1</td><td align="center" class="Botrule Lrule Rrule">0.996</td></tr><tr><td align="center" class="Botrule Lrule Rrule">2</td><td align="center" class="Botrule Lrule Rrule">0.991</td></tr><tr><td align="center" class="Botrule Lrule Rrule">5</td><td align="center" class="Botrule Lrule Rrule">0.979</td></tr><tr><td align="center" class="Botrule Lrule Rrule">10</td><td align="center" class="Botrule Lrule Rrule">0.958</td></tr><tr><td align="center" class="Botrule Lrule Rrule">24 (1 day)</td><td align="center" class="Botrule Lrule Rrule">0.901</td></tr><tr><td align="center" class="Botrule Lrule Rrule">48 (2 days)</td><td align="center" class="Botrule Lrule Rrule">0.812</td></tr><tr><td align="center" class="Botrule Lrule Rrule">72 (3 days)</td><td align="center" class="Botrule Lrule Rrule">0.731</td></tr><tr><td align="center" class="Botrule Lrule Rrule">120 (5 days)</td><td align="center" class="Botrule Lrule Rrule">0.594</td></tr><tr><td align="center" class="Botrule Lrule Rrule">168 (7 days)</td><td align="center" class="Botrule Lrule Rrule">0.482</td></tr><tr><td align="center" class="Botrule Lrule Rrule">336 (14 days)</td><td align="center" class="Botrule Lrule Rrule">0.232</td></tr><tr><td align="center" class="Botrule Lrule Rrule">720 (30 days)</td><td align="center" class="Botrule Lrule Rrule">0.044</td></tr><tr class="Last"><td align="center" class="Botrule Lrule Rrule">1080 (45 days)</td><td align="center" class="Botrule Lrule Rrule">0.009</td></tr></tbody></table></div></section>

PLUVICTO

Pluvicto

lutetium Lu 177 vipivotide tetraxetan

vipivotide tetraxetan

12.5 ML lutetium Lu 177 vipivotide tetraxetan 27 MCI/ML Injection

12.5 ML lutetium Lu 177 vipivotide tetraxetan 27 MCI/ML Injection [Pluvicto]

Psoriasis (PsO)

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