LYSAKARE (chlorhydrate de L-Arginine/ chlorhydrate de L-Lysine)

Renal protection during radiopharmaceutical treatment - Sector: Hospital
Opinions on drugs - Posted on Mar 31 2020

Reason for request

First assessment

Key points

Favourable opinion for reimbursement for the reduction of renal radiation exposure during Peptide-Receptor Radionuclide Therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.

What therapeutic improvement?

No clinical added value compared to the hospital preparation.

Role in the care pathway?

During Peptide-Receptor Radionuclide Therapy (PRRT), the kidneys are exposed to high levels of radiation. The administration of a solution of 2.5% lysine and 2.5% arginine in 1 litre of 0.9% sodium chloride solution reduces the radiation dose administered to the kidney. Other solutions with a lysine and arginine content of 18 to 24 g can also be used, but these are more likely to cause nausea and vomiting due to their higher osmolarity and the larger volume administered.

Several learned societies recommend the co-administration of an amino acid solution in patients treated with PRRT in gastroenteropancreatic neuroendocrine tumours.

For any administration of LUTATHERA (lutetium (177Lu) oxodotreotide), section 4.2 of the SPC specifies that co-administration of amino acid solutions is essential to protect renal function. In addition, an anti-emetic treatment should be administered 30 minutes before the start of the amino acid infusion to limit nausea and vomiting associated with this infusion.

Role of LYSAKARE (L-Arginine hydrochloride / L-Lysine hydrochloride) in the care pathway:

LYSAKARE is a first-line treatment for the reduction of renal radiation exposure during Peptide-Receptor Radionuclide Therapy (PRRT) with lutetium (177Lu) oxodotreotide.


Clinical Benefit

Substantial

The clinical benefit of LYSAKARE (L-Arginine hydrochloride / L-Lysine hydrochloride) is substantial in the MA indication.


Clinical Added Value

no clinical added value

In the absence of prospective and comparative data specific to LYSAKARE (L-Arginine hydrochloride / L-Lysine hydrochloride), the Committee considers that LYSAKARE provides no clinical added value (CAV V) compared to the hospital preparation with the same composition.


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