PRESERVE WHAT
MATTERS MOST,
ONE DIGIT AT
A TIME
With AURLUMYN, you can significantly decrease the likelihood of digit amputation in patients with severe frostbite1
Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.1
Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.1
AURLUMYN is the only FDA-approved treatment for severe frostbite* that combines the ability to:
AURLUMYN rapidly and simultaneously addresses 2 key components of secondary injury in frostbite (vasoconstriction and platelet aggregation) with a dual mechanism of action.1,2
AND
In the clinical study, 0% of patients treated with iloprost IV alone (0/16) and 19% of patients treated with iloprost IV + tPA (3/16) were at risk of digit amputation, regardless of frostbite grade.1,†
AND
With a 48- and possibly up to 72-hour treatment-initiation window after rewarming, you can treat more patients.3,‡
*Severe frostbite was defined as having at least one digit (finger or toe) with frostbite stage 3 (lesion extending just past the proximal phalanx) or stage 4 (lesion extending proximal to the metacarpal or metatarsal joint).1 †Compared with 60% of patients in the control group (9/15).1 ‡In the clinical study, among the 47 patients with severe frostbite at enrollment, 31 (66%) were treated within the first 12 hours post-rewarming, 39 (83%) within the first 24 hours, and 6 (13%) after 48 hours.4 FDA=US Food and Drug Administration; IV=intravenous; tPA=tissue plasminogen activator.
AURLUMYN is on a mission to reduce severe frostbite amputations.
Join the movement and help bring them closer to zero.
INDICATIONS AND USAGE
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.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
AURLUMYN may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN.
Adverse Reactions
Adverse events reported with the use of intravenous (IV) iloprost in patients with frostbite include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension.
Use in Specific Populations
- Advise women not to breastfeed during treatment with AURLUMYN.
- The safety and efficacy of AURLUMYN in pediatric patients have not been established.
- Dosage adjustment is recommended in patients with moderate or severe hepatic impairment.
- In patients with eGFR <30 mL/min, dosage adjustment can be considered based on tolerability. The effect of dialysis on the clearance of AURLUMYN has not been evaluated.
To report suspected adverse reactions, contact BTG at 1-877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
- AURLUMYN (iloprost) [prescribing information]. BTG International, Inc.
- Knapik JJ, Reynolds KL, Castellani JW. Frostbite: pathophysiology, epidemiology, diagnosis, treatment, and prevention. J Spec Oper Med. 2020;20(4):123-135.
- McIntosh SE, Freer L, Grissom CK, et al. Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Frostbite: 2024 Update. Wilderness Environ Med. 2024;35(2):183-197.
- 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;364(2):189-190; Cheguillaume B. Controlled trial of iloprost and iloprost and rt-PA in the treatment of severe frostbite. Doctoral thesis. Grenoble School of Medicine; 2011.
