SERB Pharmaceuticals has announced the commercial availability in the US of Aurlumyn™ (iloprost) Injection, the first FDA-approved treatment for severe frostbite in adults aimed at reducing the risk of digit amputations. This milestone offers a new approach to managing a condition that can lead to devastating consequences for affected individuals.
Dr. Jennifer Dow, an emergency medicine physician, highlighted the significance of this development, stating that Aurlumyn represents a new era of hope for patients at risk of digit amputations and could revolutionize the standard of care for frostbite.
Addressing a Critical Unmet Need
Frostbite, a condition resulting from exposure to extreme cold, affects thousands in the US annually, often leading to hospitalization. Those most vulnerable include winter sports enthusiasts, military personnel, outdoor workers, and the unhoused. Severe cases can result in digit or limb necrosis, frequently requiring amputation.
Thomas Kolaras, Executive Vice President and US Chief Commercial Officer at SERB Pharmaceuticals, expressed pride in making Aurlumyn available to hospitals, first responders, and military customers, emphasizing its potential to empower healthcare professionals in critical moments.
Clinical Recommendations and Usage
The Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Frostbite strongly recommends considering Aurlumyn as a first-line therapy for Grades 3 and 4 frostbite when administered less than 48 hours after thawing, and potentially up to 72 hours.
Aurlumyn (iloprost) functions as a prostacyclin mimetic, acting as a vasodilator to open blood vessels and inhibit platelet aggregation. It is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Clinical effectiveness was demonstrated in young, healthy adults who suffered frostbite at high altitudes.
Aurlumyn received priority review and orphan drug designation from the FDA, and was initially approved in February 2024.
Important Safety Information
Key considerations for Aurlumyn administration include:
- Hypotension: Aurlumyn may cause symptomatic hypotension. Correct hypotension prior to administration and monitor vital signs during administration.
- Adverse Reactions: Reported adverse events include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension.
- Specific Populations: Women should not breastfeed during treatment. The safety and efficacy in pediatric patients have not been established. Dosage adjustments are recommended for patients with moderate or severe hepatic impairment and may be considered for those with eGFR <30 mL/min.
