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Lutetium Lu 177 Dotatate peptide vial

Lutetium Lu 177 Dotatate

FDA approved

Lutetium Lu 177 dotatate (Lutathera) is a radioactive peptide therapy approved by the FDA in 2018 for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It delivers radiation directly to tumor cells.

At a glance

Where it acts
Digestive & weight
Regulatory status
FDA approvedApproved by the U.S. FDA for at least one medical use.

Mechanism of Action

The drug pairs a somatostatin analog peptide (octreotate) with the radioactive isotope lutetium-177. The peptide binds somatostatin receptors, which are overexpressed on neuroendocrine tumor cells; the bound complex is internalized and its beta radiation damages tumor DNA.

Typical Dosage (Research)

Prescription-only medicine. Dosing is set by a physician according to the FDA-approved label and the condition being treated.

Side Effects & Risks

Low blood counts, nausea, vomiting, fatigue, raised liver enzymes and low potassium.

Radiation exposure, bone marrow suppression, a small risk of secondary blood cancers (myelodysplastic syndrome, leukemia), kidney toxicity, hormonal crises from tumor release, and harm to a fetus. Requires radiation safety precautions.

Who Uses Lutetium Lu 177 Dotatate

Adults and children 12 and older with somatostatin receptor-positive GEP-NETs, given by specialist nuclear medicine teams.