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

Prior treatment

• 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 illness

• 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.

Lab values

• Pre-existing hyperkalemia (\>6.0 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion. For Poland only, pre-existing hyperkalemia (\> 5.5 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion.
• \- Pre-existing hyperkalemia (\> 5.5 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion.

Other

• 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.
• Other protocol-defined exclusion criteria may apply.

• 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.