New consensus guidelines provide specific recommendations for use of Voraxaze® in patients with dela

BTG plc (LSE: BTG), the global specialist healthcare company, announces the publication of new consensus guidelines for use of Voraxaze^® (glucarpidase) in patients with high-dose methotrexate-induced acute kidney injury and delayed methotrexate clearance in The Oncologist.

High-dose methotrexate, defined as a dose higher than 500 mg/m², is used to treat a range of adult and childhood cancers, including, osteosarcoma, acute lymphoblastic leukemia, and primary central nervous system lymphoma. Acute kidney injury due to high-dose methotrexate is a serious, life-threatening toxicity that can occur in pediatric and adult patients. Voraxaze^® (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function.

Until now, there have been no available consensus guidelines on the use of Voraxaze^®. An international group of experts was convened to develop a consensus guideline that was specific and evidence-based to identify the population of patients who would benefit from Voraxaze^®. These new guidelines recommend that “administration of Voraxaze® should optimally occur within 48–60 hours from the start of the HDMTX infusion, because life-threatening toxicities may not be preventable beyond this time point”.

Dr. Peter C. Adamson of the Children’s Hospital of Philadelphia, who is Chair of the Children’s Oncology Group and Professor of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, commented, “These guidelines provide a much-needed framework for how to treat patients with acute kidney injury secondary to high dose MTX. The publication will provide clinicians both practical and specific guidance on when and how to treat patients with glucarpidase to optimize the potential for benefit.”

Suzanne Ward, PharmD, MBA, Senior Director of Medical Strategy for Specialty Pharmaceuticals at BTG states: “The medical community has long awaited definitive expert-consensus on how to manage delayed methotrexate elimination due to acute kidney injury, including the appropriate timeframe to intervene with glucarpidase. These guidelines provide very specific plasma methotrexate concentration thresholds as early as 24 hours following the start of methotrexate infusion, allowing clinicians to promptly identify patients at risk so that treatment occurs without delay, minimizing unnecessary over-exposure to methotrexate and toxicity progression.”

The guideline provides recommendations to identify the population of patients who would benefit from glucarpidase rescue by more precisely defining the absolute methotrexate concentrations associated with risk for severe or life-threatening toxicity at several time points after the start of a high-dose methotrexate infusion. Early administration of Voraxaze^®may diminish the risk for serious life threatening toxicity and even death.