Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

Inclusion Criteria:

Patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for the treatment with Lutathera as per Lutathera label indication.
Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related procedures.

Exclusion Criteria:

Pre-existing hyperkalemia (>6.0 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion (applicable to all countries except Poland).
Instances when Lutathera is not recommended per the Lutathera Summary of Product Characteristics (SmPC).
Pregnancy or lactation, positive pregnancy test at screening or pre-dose based on the contraindication for Lutathera.
Any significant medical or social condition which may interfere with the subject's ability to comply with the study visit schedule or the study assessments.
Patients who have received any investigational agent within the last 30 days.
Patients that have received a dose of Lutathera prior to the screening visit or are scheduled for Peptide Receptor Repeat (PRRT) treatment within 7 days of the study infusion of arginine/lysine solution.
Other protocol-defined exclusion criteria may apply.

Exclusion Criteria (Poland Only):

- Pre-existing hyperkalemia (> 5.5 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion.