2007;12:1299-1308. Under the terms of the partnership, WEP will manage the exclusive distribution of BTG’s rescue medicine, Voraxaze® (glucarpidase), in the UK, European Union (EU) and European Economic Area (EEA) market. WEP Clinical (WEP) announced today that it has entered into a partnership with BTG Specialty Pharmaceuticals (BTG), a division of Boston Scientific. Over the past 25 years, the National Comprehensive Cancer Network (NCCN) has developed. Institute for Safe Medication Practices. Understanding and managing methotrexate nephrotoxicity. 2010; 28:3979-3986. Flombaum C, Meyers P. High-dose leucovorin as sole therapy for methotrexate toxicity. BTG Specialty Pharmaceuticals, a division of Boston Scientific, provides rescue medicines typically used in emergency rooms and intensive care units to treat patients for whom there are limited treatment options. We are dedicated to the development, manufacture, and commercialization of quality medicines that make a real difference to patients and their families. Am J Kidney Dis 1996; 28(6):846-854. Schwartz S, Borner K,Müller K, et al. Widemann BC, Balis FM, Kempf-Bielack B, et al. Following EMA approval, WEP will market and promote Voraxaze® within the key European territories through its specialist field force. Consensus guidelines for use of glucarpidase in patients with high-dose methotrexate induced acute kidney injury and delayed methotrexate clearance. http://www.pbm.va.gov/clinicalguidance/drugmonographs/Glucarpidase_ Drug_Monograph_and_Considerations_for_Use.doc. 3. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Accessed July 24, 2019. NCCN Guidelines®. Glucarpidase (Voraxaze®) National Drug Monograph and Considerations for Use. Dart RC, Goldfrank LR, Erstad BL, et al. For related questions regarding DigiFab ®, please contact the BTG Specialty Solutions Center ™ at 1-844-293-0007, or email DigiFab@btgsp.com Journal of Clinical Oncology 1999; 17(5): 1589-1594. Am J Kidney Dis 2009; 53:781-874. 2018;71(3):314-325. Expert Consensus Guidelines published in 2018 recommend that all hospitals that provide emergency care should stock 5 vials of Voraxaze®, The Institute for Safe Medication Practices (ISMP) recommends that all appropriate antidotes should be readily available, Standardized protocols and/or a coupled order should be set in place that permit the emergency administration of all appropriate antidotes used in the facility, Serious hypersensitivity reactions, including anaphylactic reactions, may occur. 4. To learn more, please visit: btgsp.com. 2. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Find out more about how we use your information in our Privacy Policy and Cookie Policy. Service Desk Specialist Arraya Solutions. Patient Advocacy Partnership – Case Studies. WEP will utilize its expertise in Named Patient medicine supply to distribute this much-needed drug to patients within the EU as an unlicensed medicine. High-dose methotrexate toxicity in elderly patients with primary central nervous system lymphoma. That means ensuring our vital products are available when needed. 2004;100:2222-2232. BTG Specialty Pharmaceuticals is seeking marketing authorization of Voraxaze “This partnership with BTG fully demonstrates WEP Clinical’s commitment to supporting industry in making life-saving treatments available to patients in need around the world”, said Jas Khera, Managing Director EU, WEP Clinical. Our current portfolio of antidotes counteracts certain snake venoms and the toxicity associated with some heart and cancer medications. Ramsey L, Balis FM, O’Brien MM, et al. Methotrexate clearance by high-flux hemodialysis and peritoneal dialysis: a case report. Dart RC, Goldfrank LR, Erstad BL, et al. Green JM. Voraxaze® is included in the following guidelines: Early intervention with Voraxaze®, a recombinant bacterial enzyme that provides an alternative route for methotrexate clearance, has shown efficacy in rapidly reducing plasma concentrations of methotrexate and preventing severe toxicity. Bedford Laboratories; 2011. Our priority is to protect and aid the health and safety of our employees, our customers and their patients. --BTG Specialty Pharmaceuticals, a division of Boston Scientific, today announced the European Medicines Agency has accepted for review a Marketing Authorisation Application for Voraxaze ®. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. Voraxaze® is a registered trademark of Protherics Medicines Development Ltd., a BTG International group company. The Oncologist 2016; 21:1-12. Effective clearance of methotrexate using high-flux hemodialysis membranes. Ann Emerg Med. High-dose methotrexate-induced nephrotoxicity in patients with osteosarcoma. 2008;23:3762-3766. 2018-2019 targeted medication safety best practices for hospitals. Murashima M, et al. Early and rapid reduction of methotrexate (MTX) concentrations can lower the risk of irreversible damage. Established in 2008, WEP is a specialist pharmaceutical services company that works with sponsors to help patients and physicians gain access to medicines when there is no treatment available in their country. How BTG Specialty Pharmaceuticals is Responding to the COVID-19 pandemic. It also means finding new and creative ways to support the frontline healthcare providers working tirelessly to address the COVID-19 pandemic. Serious hypersensitivity reactions occurred in less than 1% of patients, Methotrexate concentrations within 48 hours following Voraxaze, In clinical trials, the most common related adverse events (occurring in >1% of patients) were paresthesia, flushing, nausea and/or vomiting, hypotension and headache. Conshohocken, Pennsylvania, United States. “We have worked hard to ensure the appropriate infrastructure and processes are in place to allow for effective and timely distribution and we have dedicated in-house teams ready to put their all behind this new program.”, “We look forward to working with BTG to maximize the potential of Voraxaze, from early named patient sales, right through to product approval and EU commercialization.”. The Oncologist. 2014. WEP Clinical is a global organisation and possesses all necessary licenses required to meet drug access and distribution needs across all regions, worldwide. National Comprehensive Cancer Network. Voraxaze® [prescribing information]. WEP will also support BTG with its market access and launch strategy for Voraxaze® in key European territories, following the submission of its planned Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA). 2018;23(1):52-61. 2006;11:694-703. Not every patient requires Voraxaze®, but having it on hand can help you be prepared in an emergency. Ramsey LB, Balis FM, O’Brien MM, et al. Consensus guidelines for use recommend administration of Voraxaze® at 48 hours following initiation of high-dose methotrexate (HDMTX) therapy when MTX concentrations are above 5 μM (2.27 μg/mL) and the serum creatinine is elevated relative to the baseline measurement. Ther Clin Risk Manag. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcome. Leucovorin [prescribing information]. Ann Oncol. Nephrol Dial Transplant. 2012;8:403-4. Preventing and managing toxicities of high-dose methotrexate. Oncologist. BTG Specialty Solutions CenterTM is a trademark of BTG International Ltd. Ⓒ 2019 BTG International Inc. All rights reserved. https://www.ismp.org/sites/default/files/attachments/2019-01/TMSBP-for-Hospitalsv2.pdf. Oncologist. Information about your device and internet connection, including your IP address, Browsing and search activity while using Verizon Media websites and apps. 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. Consensus guidelines for use of glucarpidase in patients with high-dose methotrexate induced acute kidney injury and delayed methotrexate clearance. 2005;16:445-449. BTG Specialty Pharmaceuticals. Ann Emerg Med. 2018;71(3):314-325. BTG International Inc. 300 Four Falls Center Suite 300 300 Conshohocken State Road West Conshohocken, PA 19428 USA. U.S. Department of Veterans Affairs website. Jahnke K, Korfel A, Martus P, et al; on behalf of the German Primary Central Nervous System Lymphoma Study Group (G-PCNSL-SG). Wall S, Johansen M, et al. BTG Specialty Pharmaceuticals, a division of Boston Scientific (NYSE:BSX), today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorisation Application (MAA) for Voraxaze® (glucarpidase). Our priority is to protect and aid the health and safety of our employees, our customers and their patients. BTG International Inc. 2012. de Miguel D, García-Suárez J Martín Y, Gil-Fernández JJ, Burgaleta C. Severe acute renal failure following high-dose methotrexate therapy in adults with haematological malignancies: a significant number result from unrecognized co-administration of several drugs.