Iloprost IV has a favorable benefit-risk profile
No serious adverse events reported in clinical trials1,2,*
- Adverse reactions reported with the use of iloprost IV included headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension1
- None of the adverse reactions reported with iloprost IV led to treatment discontinuation2
AURLUMYN enables you to intervene and treat severe frostbite
No contraindications1
No known drug interactions1
Has not been shown to initiate systemic bleeding1,†
Can be used in patients with hepatic or renal impairment with appropriate dose titration1
Does not require imaging to assess for active bleeding or recent surgery3,4
The first documented use of iloprost IV for frostbite was in 19945,6,‡
AURLUMYN may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN.1
*Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.1
†AURLUMYN does not break down fibrin clots and did not initiate systemic bleeding in the clinical trial.7
‡Only the United States has a formal product-label indication for iloprost IV in severe frostbite. Its use in frostbite outside the US is limited to clinical practice settings and is not part of the approved product labeling.1,5
IV=intravenous.
Treatment-initiation window
With up to a 48- and possibly up to 72-hour treatment-initiation window after rewarming, you can treat more patients.4,§
§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.2
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.
- 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
- Handford C, Buxton P, Russell K, et al. Frostbite: a practical approach to hospital management. Extrem Physiol Med. 2014;3:7.
- 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.
- Gauthier J, Morris-Janzen D, Poole A. Iloprost for the treatment of frostbite: a scoping review. Int J Circumpolar Health. 2023;82(1):2189552.
- Groechenig E. Treatment of frostbite with iloprost. Lancet. 1994;344(8930):1152-1153.
- Siniarski A, Gąsecka A, Starczyński M, et al. Prostacyclin analogues decrease platelet aggregation but have no effect on thrombin generation, fibrin clot structure, and fibrinolysis in pulmonary arterial hypertension: PAPAYA coagulation. Platelets. 2022;33(7):1065-1074.
