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The effect of LysaKare infusion on serum potassium levels in patients with gastroenteropancreatic neuroendocrine tumours eligible for treatment with [ 177 Lu ]Lu‐ DOTA ‐ TATE : A post‐authorisation safety study

Year: 2026

Type: article

Abstract: A post‐authorisation safety study (PASS) was conducted to assess the impact of LysaKare (2.5% Lysine‐Arginine solution) on serum potassium concentrations and its safety/tolerability profile in patients with gastroenteropancreatic neuroendocrine tumours (GEP‐NET) eligible for 177 Lu‐DOTATATE treatment. In a phase IV, multicentre, single‐arm, open‐label PASS, adults with somatostatin receptor‐positive GEP‐NET who were eligible for 177 Lu‐DOTATATE treatment received 1000 mL of LysaKare (monotherapy) intravenously over 4 h. The primary endpoint was the change in serum potassium levels over the course of 24 h. Secondary endpoints included the incidence of LysaKare‐related adverse events (AEs) and changes in laboratory parameters. Forty‐one patients were treated (median age, 57 years; 92.7% White and 7.3% Black; 53.7% male) and 40 completed post‐treatment follow‐up. Mean (standard deviation [SD]) serum potassium was 4.33 (0.397) mmol/L pre‐dose, increasing by 0.60 (0.666) mmol/L after 4 h (time to maximum change, range, 2–24 h) before decreasing to around the pre‐dose level: the mean (SD) increase after 24 h was 0.07 (0.396) mmol/L. Other electrolytes and blood gas components mostly showed transient changes that lasted ~24 h. A general trend of transient metabolic acidosis was also observed based on laboratory values. Serum potassium grade increased from baseline in 41.5% of patients. By comparison, five patients (12.2%) had a treatment‐related AE of hyperkalaemia (grade 3, n = 1); all resolved within 24 h, either without treatment ( n = 3) or following intravenous furosemide ( n = 2). There were no serious AEs and no AEs leading to treatment discontinuation/interruption. This PASS identified no new safety signals attributable to LysaKare. Trial registration: EudraCT, 2019‐004073‐76. Registered 20/08/2020.

Source: Journal of Neuroendocrinology

DOI: 10.1111/jne.70172