{"id":1220,"date":"2019-07-11T00:00:00","date_gmt":"2019-07-11T00:00:00","guid":{"rendered":"https:\/\/protherics2.aazzxx.com\/news\/nccn-issues-first-pediatric-acute-lymphoblastic-leukemia-guidelines-including-use-of-voraxaze\/"},"modified":"2022-09-08T09:37:56","modified_gmt":"2022-09-08T09:37:56","slug":"nccn-issues-first-pediatric-acute-lymphoblastic-leukemia-guidelines-including-use-of-voraxaze","status":"publish","type":"news","link":"https:\/\/serb.com\/nl\/news\/nccn-issues-first-pediatric-acute-lymphoblastic-leukemia-guidelines-including-use-of-voraxaze\/","title":{"rendered":"NCCN issues first pediatric acute lymphoblastic leukemia guidelines, including use of Voraxaze\u00ae"},"content":{"rendered":"<p>BTG plc (LSE: BTG), the global healthcare company, today highlighted the first publication of National Comprehensive Cancer Network (NCCN) pediatric acute lymphoblastic leukemia (ALL)\u00a0<a href=\"https:\/\/www.journalofclinicalpathways.com\/news\/breaking-nccn-releases-first-guideline-pediatric-cancer\">guidelines<\/a>\u00a0including consideration of Voraxaze<sup>\u00ae<\/sup>\u00a0(glucarpidase).<\/p>\n<p>This is in addition to updated NCCN guidelines for central nervous system (CNS) cancer, which now reference new consensus guidelines for Voraxaze<sup>\u00ae<\/sup>. Inclusion of Voraxaze<sup>\u00ae<\/sup>\u00a0is based on publication of consensus guidelines for use of Voraxaze<sup>\u00ae<\/sup>\u00a0in patients with high-dose methotrexate-induced acute kidney injury and delayed methotrexate clearance in\u00a0<em>The Oncologist<sup>i<\/sup>.<\/em><\/p>\n<p>High-dose methotrexate, defined as a dose higher than 500 mg\/m<sup>2<\/sup>, 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<sup>\u00ae<\/sup>\u00a0is indicated for the treatment of toxic plasma methotrexate concentrations (&gt;1 \u03bcmol\/L) in patients with delayed methotrexate clearance due to impaired renal function.<\/p>\n<p>\u201cNCCN 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,\u201d said Suzanne Ward, PharmD, MBA, Senior Director of Medical Strategy for Specialty Pharmaceuticals at BTG. \u201cThe 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.\u201d<\/p>\n<p><strong>About Methotrexate Toxicity:<\/strong><\/p>\n<p>Methotrexate is a potent anticancer agent used in high doses (&gt;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<sup>\u00ae<\/sup>\u00a0is associated with significantly lower rates of toxicity and mortality.<sup>ii<\/sup><\/p>\n<p><strong>About Voraxaze<\/strong><sup>\u00ae<\/sup><strong>:<\/strong><\/p>\n<p>Acute kidney injury due to high\u2010dose methotrexate (HDMTX) is a serious, life\u2010threatening toxicity that can occur in pediatric and adult patients. Voraxaze<sup>\u00ae<\/sup>\u00a0(glucarpidase) is a treatment approved by the Food and Drug Administration for the treatment of toxic plasma methotrexate concentrations (&gt;1 \u03bcmol\/L) in patients with delayed methotrexate clearance due to impaired renal function. In clinical studies, all patients treated with Voraxaze<sup>\u00ae<\/sup>\u00a0experience rapid reductions in plasma MTX concentrations and 91% of patients achieved sustained reductions for up to 8 days.<sup>ii<\/sup><\/p>\n<p><strong>About BTG Pharmaceuticals.<\/strong><\/p>\n<p>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:\u00a0<a href=\"https:\/\/btgplc.com\/pharmaceuticals\" target=\"_blank\" rel=\"noopener\">btgplc.com\/pharmaceuticals<\/a>.<\/p>\n<p><strong>For further information contact:<\/strong><\/p>\n<p>Chris Sampson, Corporate Communications Director<\/p>\n<p>+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178<\/p>\n<p>Chris Gale, Greentarget<\/p>\n<p><a href=\"tel:(646)%20695-2883\">(646) 695-2883<\/a>; Mobile:\u00a0<a href=\"tel:(203)%20570-4681\">(203) 570-4681<\/a><\/p>\n<p><strong>Indication and Limitations of Use<\/strong><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Voraxaze<sup>\u00ae<\/sup>\u00a0(glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (&gt;1 \u03bcmol\/L) in patients with delayed methotrexate clearance due to impaired renal function<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Voraxaze<sup>\u00ae<\/sup>\u00a0is not indicated for use in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Important Safety Information<\/strong><\/p>\n<p>Adverse Reactions<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>In clinical trials, the common related adverse events (occurring in &gt;1% of patients) were paresthesias, flushing, nausea and\/or vomiting, hypotension, and headache<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Warnings and Precautions<\/strong><\/p>\n<p>Serious Allergic Reactions<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Serious allergic reactions, including anaphylactic reactions, may occur Monitoring Methotrexate Concentration\/Interference With Assay<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Methotrexate concentrations within 48 hours following Voraxaze<sup>\u00ae<\/sup>\u00a0administration can only be reliably measured by a chromatographic method due to interference from metabolites. Measurement of methotrexate concentrations within 48 hours of Voraxaze<sup>\u00ae<\/sup>\u00a0administration using immunoassays can overestimate the methotrexate concentration<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>Continuation and Timing of Leucovorin Rescue<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Leucovorin should not be administered within 2 hours before or after Voraxaze<sup>\u00ae<\/sup>\u00a0dose because leucovorin is a substrate for Voraxaze<sup>\u00ae<\/sup><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>For the first 48 hours after Voraxaze<sup>\u00ae<\/sup>, administer the same leucovorin dose as given prior to Voraxaze<sup>\u00ae<\/sup>. Beyond 48 hours after Voraxaze<sup>\u00ae<\/sup>, administer leucovorin based on the measured methotrexate concentration<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Do not discontinue therapy with leucovorin based on the determination of a single methotrexate concentration below the leucovorin treatment threshold<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Therapy with leucovorin should be continued until the methotrexate concentration has been maintained below the leucovorin treatment threshold for a minimum of 3 days<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Continue hydration and alkalinization of the urine as indicated<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><sup>i<\/sup>\u00a0The Oncologist\u00a0October 2017theoncologist.2017-0243<\/p>\n<p><sup>ii<\/sup>Voraxaze<sup>\u00ae<\/sup>\u00a0[prescribing information]. BTG International Inc; 2016.<\/p>\n<p><sup>iii<\/sup>Widemann 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.<\/p>\n<p><sup>iv<\/sup>2013 Annual Meeting of the North American Congress of Clinical Toxicology (NACCT), Clinical Toxicology 2013; 51(7):575-724. doi:10.3109\/15563650.2013.817658.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BTG plc (LSE: BTG), the global healthcare company, today highlighted the first publication of National Comprehensive Cancer Network (NCCN) pediatric acute lymphoblastic leukemia (ALL)\u00a0guidelines\u00a0including consideration of Voraxaze\u00ae\u00a0(glucarpidase). This is in addition to updated NCCN guidelines for central nervous system (CNS) cancer, which now reference new consensus guidelines for Voraxaze\u00ae. Inclusion of Voraxaze\u00ae\u00a0is based on publication [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-1220","news","type-news","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>NCCN issues first pediatric acute lymphoblastic leukemia guidelines, including use of Voraxaze\u00ae - SERB Pharmaceuticals<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/serb.com\/news\/nccn-issues-first-pediatric-acute-lymphoblastic-leukemia-guidelines-including-use-of-voraxaze\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NCCN issues first pediatric acute lymphoblastic leukemia guidelines, including use of Voraxaze\u00ae - SERB Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"BTG plc (LSE: BTG), the global healthcare company, today highlighted the first publication of National Comprehensive Cancer Network (NCCN) pediatric acute lymphoblastic leukemia (ALL)\u00a0guidelines\u00a0including consideration of Voraxaze\u00ae\u00a0(glucarpidase). 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