Lutetium Lu 177 dotatate (Lutathera®) was approved in January 2018 by the U.S. Food and Drug Administration (FDA) to treat a specific group of neuroendocrine tumors (NETs) in the gastrointestinal tract. NETs are rare, and the tumors produce hormone-like substances in response to signals from the nervous system.
Radiolabeled somatostatin analog
The FDA approval is for the treatment of somatostatin receptor-positive gastroenteropancreatic NETs, including foregut, midgut, and hindgut NETs, in adult patients.
Administer 7.4 GB (200 mCi) every eight weeks for a total of four doses.
Initiate an IV amino acid solution 30 minutes prior to administering lutetium Lu 177 dotatate, during, and for at least three hours after completing the infusion. Administer antiemetics 30 minutes prior to the amino acid solution. Infuse lutetium Lu 177 dotatate via IV at a rate of 50–100 ml per hour for 5–10 minutes, then 200–300 ml per hour for an additional 25–30 minutes. Do not administer it as an IV bolus. Administer long-acting octreotide 30 mg intramuscularly 4–24 hours after each lutetium Lu 177 dotatate dose.
Nausea (65%), vomiting (53%), fatigue (38%), abdominal pain (26%), diarrhea (26%), decreased appetite (21%), anemia (81%), thrombocytopenia (54%), and neutropenia (26%) are possible. Serious adverse reactions include myelodysplastic syndrome (2%), cardiac failure (2%), renal failure (2%), acute leukemia (1%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%).
(1) Lutetium Lu 177 dotatate requires specific training for personnel involved in administration regarding safe use and handling. Nurses should wear waterproof gloves and proper radiation shielding and use tongs to handle the drug vial. (2) Patients’ pregnancy status must be verified prior to drug administration; it may impair fertility, and women should not breastfeed. (3) A dose calibrator is used to confirm the radioactivity amount before and after administration. (4) Aggressive antiemetic prophylaxis is recommended prior to administration. (5) Periodic laboratory monitoring may include blood count, creatinine, BUN, liver function tests, prothrombin time, bilirubin, and albumin. (6) Monitor for neuroendocrine hormonal crisis during the first dose and up to 24 hours after.
Drug-Drug and Drug-Food Interactions
Discontinue long-acting somatostatin analogs for at least four weeks and short-acting somatostatin analogs at least 24 hours before administration.
Patients should understand possible adverse effects and preventative measures, including infection, bleeding from lowered platelets, and maintaining adequate hydration. Patients should also be aware of the potential for secondary malignancies and symptoms of neuroendocrine crisis. Patients of childbearing age should use contraception during treatment and for four months after the last dose.
Lutetium Lu 177 dotatate contains a radioactive element and requires safe-handling practices to prevent exposure to radiation and possible contamination. Administration requires a designated radiation therapy treatment area. Radiation can be detected in urine for up to 30 days following administration. Contact with pregnant women and infants should be minimized and the patient should use appropriate flushable toilets.
Patient assistance may be available at AAA Patient Connect's website. To find out which patients may qualify, call 844-638-7222.