BTG plc today highlighted the first publication of National Comprehensive Cancer Network (NCCN) pediatric acute lymphoblastic leukemia (ALL) guidelines including consideration of Voraxaze® (glucarpida
BTG plc (LSE: BTG), the global healthcare company, today highlighted the first publication of National Comprehensive Cancer Network (NCCN) pediatric acute lymphoblastic leukemia (ALL) guidelines including consideration of Voraxaze® (glucarpidase).
This is in addition to updated NCCN guidelines for central nervous system (CNS) cancer, which now reference new consensus guidelines for Voraxaze®. Inclusion of Voraxaze® is based on publication of consensus guidelines for use of Voraxaze® in patients with high-dose methotrexate-induced acute kidney injury and delayed methotrexate clearance in The Oncologisti.
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® is indicated for the treatment of toxic plasma methotrexate concentrations (>1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function.
“NCCN is continuing to ensure the medical community has access to current best practice on how to manage delayed methotrexate elimination due to acute kidney injury,” said Suzanne Ward, PharmD, MBA, Senior Director of Medical Strategy for Specialty Pharmaceuticals at BTG. “The published guidelines referred to by NCCN provide very specific plasma methotrexate concentration thresholds as early as 24 hours following the start of methotrexate infusion. This allows clinicians to efficiently identify at-risk patients so treatment occurs quickly, minimizing unnecessary over-exposure to methotrexate and toxicity progression.”
About Methotrexate Toxicity:
Methotrexate is a potent anticancer agent used in high doses (>500 mg/m2) to treat osteosarcoma, non-Hodgkin lymphoma, CNS lymphoma, and adult and pediatric acute lymphoblastic leukemia. Because methotrexate is primarily cleared by the kidneys, high doses can induce kidney dysfunction and delayed methotrexate elimination. Exposure to elevated concentrations of methotrexate for minutes to hours may lead to acute renal toxicity and other serious systemic adverse reactions. Early treatment with Voraxaze® is associated with significantly lower rates of toxicity and mortality.ii
Acute kidney injury due to high‐dose methotrexate (HDMTX) is a serious, life‐threatening toxicity that can occur in pediatric and adult patients. Voraxaze® (glucarpidase) is a treatment approved by the Food and Drug Administration for the treatment of toxic plasma methotrexate concentrations (>1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function. In clinical studies, all patients treated with Voraxaze® experience rapid reductions in plasma MTX concentrations and 91% of patients achieved sustained reductions for up to 8 days.ii
About BTG Pharmaceuticals.
BTG Pharmaceuticals provides antidotes that counteract the potentially life-threatening effects associated with exposure or overexposure to certain toxins. These acute care products are typically used in emergency rooms and intensive care units to treat patients for whom there are limited or no existing treatment options. We are dedicated to delivering quality medicines that make a real difference to patients through the development, manufacture, and commercialization of pharmaceutical products. To learn more about BTG Pharmaceuticals, please visit: btgplc.com/pharmaceuticals.
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i The Oncologist October 2017theoncologist.2017-0243
iiVoraxaze® [prescribing information]. BTG International Inc; 2016.
iiiWidemann BC, Balis FM, Kim A, et al. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcome. J Clin Oncol. 2010; 28:3979-3986.
iv2013 Annual Meeting of the North American Congress of Clinical Toxicology (NACCT), Clinical Toxicology 2013; 51(7):575-724. doi:10.3109/15563650.2013.817658.