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Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

 Marketing Authorisations   Glucarpidase has been granted marketing authorisation in the European Union for reducing plasma concentrations of methotrexate in patients who have received high-dose methotrexate for cancer treatment when elimination is delayed due to impaired renal function. In this situation, does glucarpidase reduce an excessively high plasma concentration of methotrexate? Does it limit the serious dose-dependent adverse effects of this cytotoxic drug? And what are its adverse effects?
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The evaluation of glucarpidase is mainly based on four non-comparative trials with similar protocols. In total, 169 patients who had delayed methotrexate elimination despite preventive measures and folinic acid administration were included in the efficacy analysis. The effect of glucarpidase on the adverse effects of methotrexate was not among the trial endpoints.

After administration of a single dose of glucarpidase, 61.5% of patients had a rapid and sustained reduction in the plasma concentration of methotrexate. 19% of patients experienced a "rebound" in methotrexate plasma concentration, defined as an increase in this concentration after an initial reduction.

In the absence of a control group, it is not known whether glucarpidase reduces the frequency or severity of the adverse effects of methotrexate, nor whether it reduces mortality.

©Prescrire 1 September 2023

Source: "Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity" Prescrire International 2023; 32 (251): 204-205. Subscribers only.

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