{"id":3209,"date":"2024-12-09T13:22:56","date_gmt":"2024-12-09T13:22:56","guid":{"rendered":"https:\/\/serb.com\/?post_type=news&#038;p=3209"},"modified":"2024-12-09T13:23:16","modified_gmt":"2024-12-09T13:23:16","slug":"first-fda-approved-treatment-for-severe-frostbite-now-commercially-available-in-the-us","status":"publish","type":"news","link":"https:\/\/serb.com\/nl\/news\/first-fda-approved-treatment-for-severe-frostbite-now-commercially-available-in-the-us\/","title":{"rendered":"First FDA-approved treatment for severe frostbite now commercially available in the US\u00a0"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Philadelphia, 9 December 2024: <\/strong>SERB Pharmaceuticals, a global specialty pharmaceutical company, is proud to announce that Aurlumyn\u2122 (iloprost) Injection, the <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-medication-treat-severe-frostbite\">first FDA-approved treatment for severe frostbite<\/a> in adults to reduce the risk of digit amputations, is now commercially available in the US.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aurlumyn \u2122 is available through specialty distribution by FFF Enterprises Inc. Customers interested in ordering can call 1-800-843-7477 or visit <a href=\"https:\/\/biosupply.fffenterprises.com\">https:\/\/biosupply.fffenterprises.com<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aurlumyn\u2122 will be formally launched during this week\u2019s American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting &amp; Exhibition. ASHP meeting attendees can learn more about Aurlumyn \u2122 by visiting booth 339.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dr. Jennifer Dow, Emergency Medicine physician at Alaska Regional Hospital and Medical Director for the Alaska Region of the National Park Service, said: \u201cThis marks a significant milestone in the field of frostbite treatment in the United States, and represents a new era of hope for patients at risk of digit amputations. Frostbite can be a debilitating condition that can lead to devastating consequences for patients. We hope Aurlumyn \u2122 will revolutionize the standard of care and provide physicians with an essential tool to treat this condition and reduce the risk of amputations.&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Thomas Kolaras, Executive Vice President and US Chief Commercial Officer, said: &#8220;We are proud to make Aurlumyn\u2122 available to hospitals, first responders, and military customers in the US. This treatment empowers healthcare professionals to act decisively in critical moments, delivering hope and effective care to those at risk of life-altering complications.&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Studies show that thousands of people are hospitalized with frostbite in the US each year.<sup>2<\/sup> This rare but highly debilitating condition most often affects winter sports enthusiasts, military personnel, outdoor workers, and the unhoused. Frostbite is a high morbidity, high-cost injury that can lead to digit or limb necrosis requiring amputation.<sup>3<\/sup> Aurlumyn\u2122 is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The most recent Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Frostbite strongly recommends considering Aurlumyn\u2122 as a first-line therapy for Grades 3 and 4 frostbite &lt;48 hours after thawing, and possibly for up to 72 hours.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About SERB Pharmaceuticals<br><\/strong>SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB is a leading provider of essential acute care medicines, addressing unmet medical needs and supplying antidotes and medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Learn more at <a href=\"https:\/\/SERB.com\">https:\/\/SERB.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About Aurlumyn\u2122 (OR-LOO-MIN)<br><\/strong>Aurlumyn\u2122 is a prostacyclin mimetic and acts as a vasodilator (a drug that opens blood vessels) and inhibits platelet aggregation. Aurlumyn\u2122 is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.<sup>4<\/sup> Aurlumyn\u2122 was granted priority review and orphan drug designation (ODD) and was approved by the FDA in February of 2024 for the treatment of severe frostbite in adults to reduce the risk of digit amputations. A published case series review showed that Aurlumyn\u2122 can be effective up to 72 hours after rewarming of a frostbite patient begins.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Learn more at: <a href=\"https:\/\/aurlumyn.com\/\">https:\/\/aurlumyn.com\/<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>For further information contact:<br><\/strong>Chris Sampson, Director of Corporate Communications<br>chris.sampson@serb.com; Tel: +44 (0)7773 251 178<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>INDICATIONS AND USAGE<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>IMPORTANT SAFETY INFORMATION<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Warnings and Precautions<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AURLUMYN may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Adverse Reactions<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Adverse events reported with the use of intravenous (IV) iloprost in patients with frostbite include headache, flushing, palpitations\/tachycardia, nausea, vomiting, dizziness, and hypotension.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Use in Specific Populations<br><\/strong>\u2022 Advise women not to breastfeed during treatment with AURLUMYN.<br>\u2022 The safety and efficacy of AURLUMYN in pediatric patients have not been established.<br>\u2022 Dosage adjustment is recommended in patients with moderate or severe hepatic impairment<br>\u2022 In patients with eGFR &lt;30 mL\/min, dosage adjustment can be considered based on tolerability. The effect of dialysis on the clearance of AURLUMYN has not been evaluated.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To report suspected adverse reactions, contact BTG at 1-877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov\/medwatch.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/aurlumyn.com\/sites\/aurlumyn-library\/files\/2024-11\/PI_Aurlumyn_iloprost_label_May2024.pdf\">Please see Full Prescribing Information<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">US-AUR-2400046<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1 <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/217933s000lbl.pdf\">Aurlumyn Prescribing Information<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2 Endorf FW, Nygaard RM. Social Determinants of Poor Outcomes Following Frostbite Injury: A Study of the National Inpatient Sample. J Burn Care Res. 2021 Nov 24;42(6):1261-1265. doi: 10.1093\/jbcr\/irab115. PMID: 34139760.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3 Endorf FW, Nygaard RM. High Cost and Resource Utilization of Frostbite Readmissions in the United States. J Burn Care Res. 2021 Sep 30;42(5):857-864. doi: 10.1093\/jbcr\/irab076. PMID: 33993288.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4 Cauchy E, Cheguillaume B, Chetaille E. A controlled trial of a prostacyclin and rt-PA in the treatment of severe frostbite. N Engl J Med. 2011 Jan 13;364(2):189-90. doi: 10.1056\/NEJMc1000538. PMID: 21226604.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Philadelphia, 9 December 2024: SERB Pharmaceuticals, a global specialty pharmaceutical company, is proud to announce that Aurlumyn\u2122 (iloprost) Injection, the first FDA-approved treatment for severe frostbite in adults to reduce the risk of digit amputations, is now commercially available in the US.1 Aurlumyn \u2122 is available through specialty distribution by FFF Enterprises Inc. Customers interested [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-3209","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>First FDA-approved treatment for severe frostbite now commercially available in the US\u00a0 - 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\/nl\/news\/first-fda-approved-treatment-for-severe-frostbite-now-commercially-available-in-the-us\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First FDA-approved treatment for severe frostbite now commercially available in the US\u00a0 - SERB Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"Philadelphia, 9 December 2024: SERB Pharmaceuticals, a global specialty pharmaceutical company, is proud to announce that Aurlumyn\u2122 (iloprost) Injection, the first FDA-approved treatment for severe frostbite in adults to reduce the risk of digit amputations, is now commercially available in the US.1 Aurlumyn \u2122 is available through specialty distribution by FFF Enterprises Inc. 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