Lutathera

Lutetium (¹⁷⁷Lu) oxodotreotide

Unresectable or metastatic, progressive, well-differentiated (G1 & G2), somatostatin receptor +ve gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.

4 infusions of 7,400 MBq each by slow IV infusion for approx 30 ± 10 min at a rate of up to 400 mL/hr. Recommended interval between each administration is 8 wk. Administer amino acid soln 30 min prior to start of Lutathera infusion for 4 hr at a rate of 250-500 mL/hr. Pre-medicate w/ antiemetics at least 30 min prior to start of amino acid soln infusion.

Hypersensitivity. Kidney failure w/ CrCl <30 mL/min. Pregnancy.

Do not inject as bolus. Risk of developing adverse reactions in patients w/ bone metastasis; previous oncologic radiometabolic therapies w/ ¹³¹I-compd or any other therapy using unshielded radioactive sources; history of other malignant tumours unless considered to be in remission for at least 5 yr. Not recommended to start treatment in patients w/ somatostatin receptor -ve or mixed visceral lesions according to somatostatin receptor imaging; severely impaired haematological function at baseline (except lymphopenia); CrCl <40 mL/min at baseline. Not recommended to decrease amount of amino acid soln in case of Lutathera dose adaptation. Bladder should be emptied as frequently as possible during & hr after administration of amino acids. Assess renal function at baseline, during & at least for the 1st yr after treatment. Monitor ALT, AST, bilirubin & albumin serum during treatment. Monitor blood counts at baseline & during treatment. Risk of late-onset myelodysplastic syndrome (MDS) & acute leukaemia after treatment. Neuroendocrine hormonal crises due to excessive release of hormones or bioactive substances may occur following treatment. Reports of tumour lysis syndrome following therapy. Close contact (<1 m) w/ other people should be limited for 7 days following administration. Radiation dose resulting from therapeutic exposure may result in higher incidence of cancer & mutations. Concomitant use of somatostatin analogues. Patients w/ urinary incontinence; w/ brain metastases; on controlled Na diet; w/ severe renal impairment or ESRD; w/ severe hepatic impairment. Can cause fetal harm. Avoid pregnancy during treatment & for a min of 6 mth after end of treatment. Avoid breast-feeding during treatment. Elderly ≥70 yr. Paed patients.

Thrombocytopenia, lymphopenia, anaemia, pancytopenia; decreased appetite; nausea, vomiting; fatigue. Refractory cytopenia w/ multilineage dysplasia (MDS); leukopenia, neutropenia; secondary hypothyroidism; hyperglycaemia, dehydration, hypomagnesaemia, hyponatremia; sleep disorders; dizziness, dysgeusia, headache, lethargy, syncope; prolonged QT ECG; HTN, flushing, hot flush, hypotension; dyspnoea; abdominal distension & pain, diarrhoea, constipation, upper abdominal pain, dyspepsia, gastritis; hyperbilirubinaemia; alopecia; musculoskeletal pain, muscle spasms; acute kidney injury, haematuria, renal failure, proteinuria; inj site reaction, oedema peripheral, administration site pain, chills, flu-like illness; increased blood creatinine, γ-glutamyltransferase, ALT, AST & blood alkaline phosphatase; transfusion.

Avoid administration of long-acting somatostatin analogues w/in 30 days prior to Lutathera due to their competitive binding to somatostatin receptors. Avoid repeated administration of high-dose glucocorticosteroids due to induction of SST2 receptor down-regulation. Avoid glucocorticosteroids as preventive anti-emetic treatment.

Targeted Cancer Therapy

V10XX04 - lutetium (177Lu) oxodotreotide ; Belongs to the class of various therapeutic radiopharmaceuticals.

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