dm+d

31796611000001109

New Medicines

LysaKare Reduction of renal radiation exposure during peptide-receptor radionuclide therapy with lutetium (177Lu) oxodotreotide (Lutathera)

Information

LysaKare
New formulation
Advanced Accelerator Applications (AAA)
Not Known

Development and Regulatory status

Launched
Launched
Unknown
August 2020
Aug 20Available in the UK [4].
Jan 20The licensed product is available in the EU but not yet in the UK. Adacap expect LysaKare to be available in the UK within the next 3 to 6 months. LysaKare is available in a 1 litre bag for infusion containing 25g Lysine and 25g Arginine [3].
Jul 19Approved in the EU [1].

Category

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 [2].
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 [2].
Reduction of renal radiation exposure during peptide-receptor radionuclide therapy with lutetium (177Lu) oxodotreotide (Lutathera)
Intravenous infusion

Trial or other data

Jul 19The 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 [2].

Evidence based evaluations