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Lutathera

Lutathera

Manufacturer:

Novartis

Distributor:

Global Medical Solutions
Concise Prescribing Info
Contents
Lutetium (177Lu) oxodotreotide
Indications/Uses
Unresectable or metastatic, progressive, well-differentiated (G1 & G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
Dosage/Direction for Use
Adult 4 infusions of 7,400 MBq each by slow IV infusion for 20-30 min at 400 mL/hr infusion rate. Recommended interval between each administration: 8-16 wk. Administer amino acid soln for 4 hr at 250-550 mL/hr infustion rate 30 min prior to starting Lutathera infusion. Pre-medicate w/ antiemetics 30 min prior to start of amino acid soln infusion.
Contraindications
Hypersensitivity. Kidney failure w/ CrCl <30 mL/min. Pregnancy.
Special Precautions
Risk of developing adverse reactions in patients w/ renal or urinary tract morphological abnormalities; urinary incontinence; mild to moderate chronic kidney disease w/ CrCl ≥50 mL/min; previous chemotherapy; hematologic toxicity ≥Grade 2 (CTCAE) before treatment other than lymphopenia; 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/ previous external beam radiotherapy involving >25% of the bone marrow; severe heart failure defined as class III or IV in the NYHA classifications; kidney failure w/ CrCl <50 mL/min; impaired haematological function (except lymphopenia); liver impairment w/ either total bilirubinemia >3 times the upper limit of normal or albuminemia <30 g/L & prothrombin ratio decreased <70%; somatostatin receptor-negative or mixed visceral lesions (tumour uptake score <2) according to somatostatin receptor imaging. 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 & acute leukaemia. Hormonal crises due to excessive release of hormones or bioactive substances may occur following treatment. Radiation dose resulting from therapeutic exposure may result in higher incidence of cancer & mutations. Patients w/ urinary incontinence; brain metastases; patients on controlled Na diet. Avoid breast-feeding during treatment. Elderly ≥70 yr. Ped patients.
Adverse Reactions
Thrombocytopenia, lymphopenia, anaemia, pancytopenia; decreased appetite; nausea, vomiting; fatigue. Refractory cytopenia w/ multilineage dysplasia (myelodysplastic syndrome); 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, dyspepsia, gastritis, upper abdominal pain; 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.
Drug Interactions
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.
ATC Classification
V10XX04 - lutetium (177Lu) oxodotreotide ; Belongs to the class of various therapeutic radiopharmaceuticals.
Presentation/Packing
Form
Lutathera soln for infusion 370 MBq/mL
Packing/Price
1's
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