The effect of LysaKare infusion on serum potassium levels in patients with gastroenteropancreatic neuroendocrine tumours eligible for treatment with [Lu]Lu-DOTA-TATE: A post-authorisation safety study.
Hofland, Johannes Grana, Chiara Maria Weickert, Martin O Moore, Andrew R Shah, Tahir Prakash, Vineet Kolasińska-Ćwikła, Agnieszka de Herder, Wouter W Spada, Francesca Xu, Lingfei
Hofland, Johannes
Grana, Chiara Maria
Weickert, Martin O
Moore, Andrew R
Shah, Tahir
Prakash, Vineet
Kolasińska-Ćwikła, Agnieszka
de Herder, Wouter W
Spada, Francesca
Xu, Lingfei
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 Lu-DOTATATE treatment. In a phase IV, multicentre, single-arm, open-label PASS, adults with somatostatin receptor-positive GEP-NET who were eligible for 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.
MIDER Authors
Affiliations
Department of Internal Medicine, Section of Endocrinology, ENETS Center of Excellence, Erasmus MC Cancer Institute, Rotterdam, The Netherlands; The ARDEN NET Centre, ENETS Centre of Excellence, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK; University Hospital Birmingham NHS Foundation Trust, Birmingham, UK; et al.
Date
2026-04
Type
Article
Collections
Citation
J Neuroendocrinol . 2026 Apr;38(4):e70172