btg specialty pharmaceuticals

Widemann BC, Balis FM, Kempf-Bielack B, et al. BTG Specialty Pharmaceuticals is seeking marketing authorization of Voraxaze Find out more about how we use your information in our Privacy Policy and Cookie Policy. Consensus guidelines for use of glucarpidase in patients with high-dose methotrexate induced acute kidney injury and delayed methotrexate clearance. --BTG Specialty Pharmaceuticals, a division of Boston Scientific, today announced the European Medicines Agency has accepted for review a Marketing Authorisation Application for Voraxaze ®. Voraxaze® [prescribing information].

Our priority is to protect and aid the health and safety of our employees, our customers and their patients. 2010; 28:3979-3986. 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. BTG International Inc; 2013. 3. Institute for Safe Medication Practices.

2018;71(3):314-325. Glucarpidase to combat toxic levels of methotrexate in patients. The Oncologist. Sep 2018 – Present 1 year 11 months. Our current portfolio of antidotes counteracts certain snake venoms and the toxicity associated with some heart and cancer medications.

2018-2019 targeted medication safety best practices for hospitals. The Oncologist 2016; 21:1-12. 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.

Service Desk Specialist Arraya Solutions. US-VRX-1900083 October 2019. BTG Specialty Pharmaceuticals. Am J Kidney Dis 1996; 28(6):846-854. Yahoo is part of Verizon Media. Ann Oncol. Following EMA approval, WEP will market and promote Voraxaze® within the key European territories through its specialist field force. To learn more, please visit: btgsp.com. 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. High-dose methotrexate toxicity in elderly patients with primary central nervous system lymphoma. Oncologist. Bedford Laboratories; 2011. Am J Kidney Dis 2009; 53:781-874. Conshohocken, Pennsylvania, United States. Ther Clin Risk Manag. That means ensuring our vital products are available when needed. Effective clearance of methotrexate using high-flux hemodialysis membranes. 2012;8:403-4. Wall S, Johansen M, et al. Ann Emerg Med. May 2017 – Sep 2018 1 year 5 months. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcome. Widemann BC, Balis FM, Kim A, et al. WEP Clinical is a global organisation and possesses all necessary licenses required to meet drug access and distribution needs across all regions, worldwide. https://www.ismp.org/sites/default/files/attachments/2019-01/TMSBP-for-Hospitalsv2.pdf. “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.

Oncologist. Schwartz S, Borner K,Müller K, et al. Over the past 25 years, the National Comprehensive Cancer Network (NCCN) has developed. How BTG Specialty Pharmaceuticals is Responding to the COVID-19 pandemic. Oncologist. 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. High-dose methotrexate-induced nephrotoxicity in patients with osteosarcoma. Consensus guidelines for use of glucarpidase in patients with high-dose methotrexate induced acute kidney injury and delayed methotrexate clearance. National Comprehensive Cancer Network. 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). That means ensuring our vital products are available when needed.

Methotrexate clearance by high-flux hemodialysis and peritoneal dialysis: a case report. Early and rapid reduction of methotrexate (MTX) concentrations can lower the risk of irreversible damage. Preventing and managing toxicities of high-dose methotrexate.

It also means finding new and creative ways to support the frontline healthcare providers working tirelessly to address the COVID-19 pandemic. Green JM.

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. Watch Experts Discuss the Consensus Guidelines. http://www.pbm.va.gov/clinicalguidance/drugmonographs/Glucarpidase_ Drug_Monograph_and_Considerations_for_Use.doc. 2005;16:445-449. 2007;12:1299-1308. Glucarpidase (carboxypeptidase G2) intervention in adult and elderly cancer patients with renal dysfunction and delayed methotrexate elimination after high-dose methotrexate therapy. Accessed July 24, 2019. We are dedicated to the development, manufacture, and commercialization of quality medicines that make a real difference to patients and their families. 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. 2014. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. BTG International Inc. 300 Four Falls Center Suite 300 300 Conshohocken State Road West Conshohocken, PA 19428 USA. 4. Patient Advocacy Partnership – Case Studies. 1. 2008;23:3762-3766.

2004;100:2222-2232. Dart RC, Goldfrank LR, Erstad BL, et al. Ramsey LB, Balis FM, O’Brien MM, et al. Understanding and managing methotrexate nephrotoxicity. For related questions regarding DigiFab ®, please contact the BTG Specialty Solutions Center ™ at 1-844-293-0007, or email DigiFab@btgsp.com U.S. Department of Veterans Affairs website. 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. 2018;71(3):314-325. You can change your choices at any time by visiting Your Privacy Controls. 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. Howard SC, et al. Durham, NC. Jahnke K, Korfel A, Martus P, et al; on behalf of the German Primary Central Nervous System Lymphoma Study Group (G-PCNSL-SG). To report suspected adverse reactions, contact BTG at 1-877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. That means ensuring our vital products are available when needed. 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. Dart RC, Goldfrank LR, Erstad BL, et al. Ramsey L, Balis FM, O’Brien MM, et al. “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.”.

How BTG Specialty Pharmaceuticals is Responding to the COVID-19 pandemic. WEP Clinical (WEP) announced today that it has entered into a partnership with BTG Specialty Pharmaceuticals (BTG), a division of Boston Scientific. Cancer.

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.

Glucarpidase (Voraxaze®) National Drug Monograph and Considerations for Use.

Voraxaze® is approved in the USA and is the first and only drug approved to reduce toxic plasma methotrexate levels. 2017 Oct 27. doi: 10.1634/theoncologist.2017-0243, Widemann BC, Adamson PC. Nephrol Dial Transplant. Information about your device and internet connection, including your IP address, Browsing and search activity while using Verizon Media websites and apps. Not every patient requires Voraxaze®, but having it on hand can help you be prepared in an emergency. 2006;11:694-703. https://www.nccn.org/professionals/physician_gls/default.aspx.

Ann Emerg Med. To enable Verizon Media and our partners to process your personal data select 'I agree', or select 'Manage settings' for more information and to manage your choices. BTG Specialty Solutions CenterTM is a trademark of BTG International Ltd. Ⓒ 2019 BTG International Inc. All rights reserved. J Clin Oncol. 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. 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. Journal of Clinical Oncology 1999; 17(5): 1589-1594. 2. Data on file. Leucovorin [prescribing information]. 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. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Beyond 48 to 60 hours, life-threatening toxicities and even death may not be preventable. We and our partners will store and/or access information on your device through the use of cookies and similar technologies, to display personalised ads and content, for ad and content measurement, audience insights and product development.

NCCN Guidelines®. Our priority is to protect and aid the health and safety of our employees, our customers and their patients.

Our priority is to protect and aid the health and safety of our employees, our customers and their patients. Voraxaze® is a carboxypeptidase which breaks down methotrexate into active metabolites which are then eliminated from the body through organs other than the kidney (primarily the liver). Accessed July 24, 2019. Flombaum C, Meyers P. High-dose leucovorin as sole therapy for methotrexate toxicity. Murashima M, et al.

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