European Union - English - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuclide imaging - therapeutic radiopharmaceuticals - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Australia - English - Department of Health (Therapeutic Goods Administration)

australian nuclear science and technology organisation t/a ansto - lutetium (177lu) chloride, quantity: 10 gbq/ml - solution - excipient ingredients: dilute hydrochloric acid; purified water - lutetium (177lu) chloride is a radiopharmaceutical precursor, and it is not intended for direct use in patients. for the treatment of non resectable or metastatic neuroendocrine tumours (nets) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule.

United States - English - NLM (National Library of Medicine)

advanced accelerator applications usa, inc - lutetium oxodotreotide lu-177 (unii: ae221im3bb) (lutetium oxodotreotide lu-177 - unii:ae221im3bb) - lutetium oxodotreotide lu-177 10 mci in 1 ml - lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors in adults. none. risk summary based on its mechanism of action, lutathera can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on lutathera use in pregnant women. no animal studies using lutetium lu 177 dotatate have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from lutathera, can cause fetal harm. advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of lutetium lu 177 dotatate in human milk, or its effects on the breastfed child or

United States - English - NLM (National Library of Medicine)

hahnemann laboratories, inc. - lutetium (unii: 5h0doz21uj) (lutetium - unii:5h0doz21uj) -

European Union - English - EMA (European Medicines Agency)

itm medical isotopes gmbh - lutetium (177lu) chloride - radionuclide imaging - therapeutic radiopharmaceuticals - endolucinbeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Israel - English - Ministry of Health

novartis israel ltd - lutetium (177lu) vipivotide tetraxetan - solution for injection / infusion - lutetium (177lu) vipivotide tetraxetan 1000 mbq/ml - lutetium (177lu) vipivotide tetraxetan - pluvicto is indicated for the treatment of adult patients with prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor (ar) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

Israel - English - Ministry of Health

s.r.y. (medical services ) ltd, israel - lutetium (177lu) oxodotreotide - solution for infusion - lutetium (177lu) oxodotreotide 600 mbq/ml - lutetium (177lu) oxodotreotide - for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep-nets) in adults.

United States - English - NLM (National Library of Medicine)

advanced accelerator applications usa, inc - lutetium lu-177 vipivotide tetraxetan (unii: g6uf363ecx) (lutetium lu-177 vipivotide tetraxetan - unii:g6uf363ecx) - pluvicto is indicated for the treatment of adult patients with prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor (ar) pathway inhibition and taxane-based chemotherapy. none. risk summary the safety and efficacy of pluvicto have not been established in females. based on its mechanism of action, pluvicto can cause fetal harm [see clinical pharmacology (12.1)] . there are no available data on pluvicto use in pregnant females. no animal studies using lutetium lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radiopharmaceuticals, including pluvicto, have the potential to cause fetal harm. risk summary the safety and efficacy of pluvicto have not been established in females. there are no data on the presence of lutetium lu 177 vipivotide tetraxetan in human milk or its effects on the breastfed child or on milk production. contraception males based on its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment with pluvicto and for 14 weeks after the last dose [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] . infertility the recommended cumulative dose of 44.4 gbq of pluvicto results in a radiation absorbed dose to the testes within the range where pluvicto may cause temporary or permanent infertility. the safety and effectiveness of pluvicto in pediatric patients have not been established. of the 529 patients who received at least one dose of pluvicto plus bsoc in the vision study, 387 patients (73%) were 65 years or older and 143 patients (27%) were 75 years or older. no overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. serious adverse reactions occurred in 11% of patients ≥ 75 years of age and in 11% of younger patients. grade ≥ 3 adverse reactions occurred in 40% of patients ≥ 75 years of age and in 31% of younger patients. exposure of lutetium lu 177 vipivotide tetraxetan is expected to increase with the degree of renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is recommended for patients with mild (baseline clcr 60 to 89 ml/min by cockcroft-gault) to moderate (clcr 30 to 59 ml/min) renal impairment; however, patients with mild or moderate renal impairment may be at greater risk of toxicity. frequently monitor renal function and adverse reactions in patients with mild to moderate renal impairment [see dosage and administration (2.4)] . the pharmacokinetics and safety of pluvicto have not been studied in patients with severe (clcr 15 to 29 ml/min) renal impairment or end-stage renal disease.

Israel - English - Ministry of Health

novartis israel ltd - lutetium (177lu) oxodotreotide - solution for infusion - lutetium (177lu) oxodotreotide 370 mbq/ml - lutetium (177lu) oxodotreotide - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep nets) in adults.

Israel - English - Ministry of Health

marshall isotope ltd, israel - lutetium (177lu) oxodotreotide - solution for infusion - lutetium (177lu) oxodotreotide 370 mbq/ml - lutetium (177lu) oxodotreotide - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep nets) in adults.