Pharmacotherapeutic group: All other therapeutic products, detoxifying agents for antineoplastic treatment
ATC code: V03AF11
Arginine and lysine undergo glomerular filtration and, via competition, interfere with renal resorption of lutetium (177Lu) oxodotreotide, reducing the radiation dose delivered to the kidney.
Clinical efficacy and safety for arginine and lysine are based on published literature of studies using solutions with the same arginine and lysine content as LysaKare.
The toxicities that are observed following administration of PRRT are directly due to radiation-absorbed dose to organs. The kidneys are the critical organs for toxicity for lutetium (177Lu) oxodotreotide and dose limiting if amino acids are not administered to reduce renal uptake and retention.
A dosimetry study including 6 patients showed that a 2.5% Lysine-Arginine amino acid solution reduced renal radiation exposure by about 47% as compared to no treatment, without having an effect on tumour uptake of lutetium (177Lu) oxodotreotide. This reduction in renal radiation exposure mitigates the risk for radiation-induced renal injury.
Based on a publication of the largest study using arginine and lysine in the same quantities as LysaKare, the average kidney absorbed dose, as determined by planar imaging dosimetry, was 20.1±4.9 Gy, which is below the established threshold for the occurrence of renal toxicities of 23 Gy.
Arginine and lysine are naturally occurring amino acids that follow physiological pharmacokinetic steps and biochemical processes after infusion.
Due to the intravenous route of administration, LysaKare is 100% bioavailable.
Transient elevations in plasma arginine and lysine are observed after intravenous administration, whereupon the highly water soluble amino acids are quickly distributed throughout tissues and body fluid.
Like other naturally occurring amino acids, arginine and lysine serve as building blocks in protein anabolism and serve as precursors for several other products, including nitric oxide, urea, creatinine, and Acetyl-Coenzyme A.
Arginine and lysine are rapidly distributed. Based on a study with 30 g arginine infused over 30 minutes, plasma elimination of amino acids follows at least a biphasic or triphasic decline, with levels returning to baseline within 6 hours post-dose. Initial rapid clearance is through glomerular filtration in the kidney in the first 90 minutes post-infusion. Remaining amino acid is removed by non-renal clearance.
No pharmacokinetic data are available on the use of arginine and lysine at the same dose as LysaKare and for the same indication in paediatric patients.
There were no non-clinical studies conducted with LysaKare.
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