LysaKare · Reduction of renal radiation exposure during peptide-receptor radionuclide therapy with lutetium (177Lu) oxodotreotide (Lutathera)
Advanced Accelerator Applications (AAA)
Development and Regulatory status
Jul 19 · Approved in the EU .
L-lysine HCl and L-arginine HCl are positively charged amino acids that, following administration, undergo glomerular filtration and interfere with renal resorption of lutetium (177Lu) oxodotreotide, reducing the radiation dose delivered to the kidney .
Studies that included patients receiving radiolabeled somatostatin analog (RSA) therapy in the absence of amino acid protection reported nephrotoxicity in the range of 28% to 60%. Since the introduction of amino acids for renal protection during RSA therapy in the late 1990’s to early 2000’s, nephrotoxicity rates post-RSA treatment have been estimated to be approximately 1% to 23%, with differences in the radionuclide and amino acid solution likely contributing to variations observed .
Reduction of renal radiation exposure during peptide-receptor radionuclide therapy with lutetium (177Lu) oxodotreotide (Lutathera)
Trial or other data
Jul 19 · The main studies providing the supportive data for EU approval under a "well-established use" application were Erasmus Medical Center reports and the PIII Netter-1 study (NCT01578239). Fifteen additional publications reporting clinical use of 2.5% Lys-Arg for renal protection during treatment with 177Lu-DOTATATE or other RSAs were also submitted in support of the licence application .