Gastrointestinal Neoplasms

Pancreatic Neoplasms

Neuroendocrine Tumors

<section class="Section" data-sectioncode="34089-3"><a name="section-9"></a><h1>11     DESCRIPTION</h1>Lutetium Lu 177 dotatate is a radiolabeled somatostatin analog. The drug substance lutetium Lu 177 dotatate is a cyclic peptide linked with the covalently bound chelator 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid to a radionuclide.Lutetium Lu 177 dotatate is described as lutetium (Lu 177)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl) acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic (2-7) disulfide. The molecular weight is 1609.6 Daltons and the structural formula is as follows:<img alt="Lutetium Lu 177 dotatate structural formula" src="structure.jpg"/>LUTATHERA (lutetium Lu 177 dotatate) 370 MBq/mL (10 mCi/mL) Injection is a sterile, clear, colorless to slightly yellow solution for intravenous use. Each single-dose vial contains acetic acid (0.48 mg/mL), sodium acetate (0.66 mg/mL), gentisic acid (0.63 mg/mL), sodium hydroxide (0.64 mg/mL), ascorbic acid (2.8 mg/mL), diethylene triamine pentaacetic acid (0.05 mg/mL), sodium chloride (6.85 mg/mL), and Water for Injection (ad 1 mL). The pH range of the solution is 4.5 to 6.<div class="Section" data-sectioncode="42229-5"><a name="section-9.1"></a><h2>11.1     Physical Characteristics</h2>Lutetium-177 decays to stable hafnium-177 with a 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 (6.2%). The main radiations of lutetium-177 are detailed in Table 7.<table width="50%"><caption>Table 7. Lutetium-177 Main Radiations</caption><col align="left" 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="left" class="Botrule Lrule Rrule">Radiation</td><td align="center" class="Botrule Lrule Rrule">Energy (keV)</td><td align="center" class="Botrule Lrule Rrule">Iβ-%</td><td align="center" class="Botrule Lrule Rrule">Iγ%</td></tr><tr><td align="left" class="Botrule Lrule Rrule">β-</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="left" class="Botrule Lrule Rrule">β-</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="left" class="Botrule Lrule Rrule">β-</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="left" class="Botrule Lrule Rrule">β-</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="left" 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="left" 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">6.20</td></tr><tr><td align="left" 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="left" 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="left" 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="left" 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="section-9.2"></a><h2>11.2     External Radiation</h2>Table 8 summarizes the radioactive decay properties of lutetium-177.<table width="50%"><caption>Table 8. Physical Decay Chart: Lutetium-177 Physical Half-Life = 6.647 Days</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="Botrule First Lrule Rrule"><td align="center" class="Botrule Lrule Rrule">Hours</td><td align="center" class="Botrule Lrule Rrule">Fraction remaining</td><td align="center" class="Botrule Lrule Rrule">Hours</td><td align="center" class="Botrule Lrule Rrule">Fraction remaining</td></tr><tr class="Botrule Lrule Rrule"><td align="center" class="Botrule Lrule Rrule">0</td><td align="center" class="Botrule Lrule Rrule">1.000</td><td align="center" class="Botrule Lrule Rrule">48 (2 days)</td><td align="center" class="Botrule Lrule Rrule">0.812</td></tr><tr class="Botrule Lrule Rrule"><td align="center" class="Botrule Lrule Rrule">1</td><td align="center" class="Botrule Lrule Rrule">0.996</td><td align="center" class="Botrule Lrule Rrule">72 (3 days)</td><td align="center" class="Botrule Lrule Rrule">0.731</td></tr><tr class="Botrule Lrule Rrule"><td align="center" class="Botrule Lrule Rrule">2</td><td align="center" class="Botrule Lrule Rrule">0.991</td><td align="center" class="Botrule Lrule Rrule">168 (7 days)</td><td align="center" class="Botrule Lrule Rrule">0.482</td></tr><tr class="Botrule Lrule Rrule"><td align="center" class="Botrule Lrule Rrule">5</td><td align="center" class="Botrule Lrule Rrule">0.979</td><td align="center" class="Botrule Lrule Rrule">336 (14 days)</td><td align="center" class="Botrule Lrule Rrule">0.232</td></tr><tr class="Botrule Lrule Rrule"><td align="center" class="Botrule Lrule Rrule">10</td><td align="center" class="Botrule Lrule Rrule">0.958</td><td align="center" class="Botrule Lrule Rrule">720 (30 days)</td><td align="center" class="Botrule Lrule Rrule">0.044</td></tr><tr class="Botrule Last Lrule Rrule"><td align="center" class="Botrule Lrule Rrule">24 (1 day)</td><td align="center" class="Botrule Lrule Rrule">0.901</td><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>

Lutathera

dotatate

lutetium Lu 177 dotatate

25 ML lutetium Lu 177 dotatate 10 MCI/ML Injection

25 ML lutetium Lu 177 dotatate 10 MCI/ML Injection [Lutathera]

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event 

Prescribing Information

Submit MSL Request 

Pharmacy List 

Coverage Authorization Request 

Coverage Authorization Appeals

How To Order Lutathera

AAA PatientCONNECT Physician Portal Enrollment Form 

AAA PatientCONNECT Lutathera Enrollment Form 

Treatment Center Locator 

Enroll in Patient Savings Program 

Other HCP Resources 

About Lutathera

Treatment Journey With Lutathera

Additional Information After Receiving Lutathera

Side Effects

Safety Considerations

Radiation Safety

FAQs: GEP-NET

Safety FAQs

Patient Resources 

Lutathera Treatment Card

Instructions For Use: GEP-NET

Patient Brochure

Patient Brochure - Spanish

Patient Discussion Guide

Patient Passport & Diary