2 Information about lutetium (177Lu) oxodotreotide

Marketing authorisation indication

2.1

Lutetium (177Lu) oxodotreotide (Lutathera, AAA, referred to as lutetium) is indicated for 'unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults'.

Dosage in the marketing authorisation

2.2

Lutetium is administered as an intravenous infusion. A single cycle consists of 4 infusions of 7.4 gigabecquerels (GBq). The recommended interval between infusions is 8 weeks.