Choosing AURLUMYN at the first signs of severe frostbite can reduce risk of digit amputation
AURLUMYN can extend the treament-initiation window after rewarming1,*
- While AURLUMYN should be administered as soon as possible after rewarming, an extended treatment-initiation window means you can reduce the risk of digit amputation for patients who present late or whose frostbite has progressed to become severe1
- In an open-label, randomized, controlled study in young, healthy adults who suffered frostbite at high altitudes, iloprost IV significantly reduced the risk of digit amputation both as a monotherapy and in combination with tPA when initiated as soon as possible within 48 hours post-rewarming2,3,†
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Zero 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, compared with 60% of patients in the control group (9/15). Review the data
Iloprost IV is recommended by wilderness medicine experts as a first-line therapy for the treatment of severe frostbite up to 72 hours after rewarming.1,*
*Per wilderness medicine guidelines, the treatment-initiation window post-rewarming is 24 hours with thrombolytic therapy and up to 48, and possibly 72, hours with iloprost IV. In a case study of 5 climbers with severe frostbite, 4 of whom received iloprost IV treatment between 48 and 72 hours from injury/rewarming, 2 had results with minimal tissue loss and 2 had results with tissue loss less than expected.1,4
†Prior to randomization into the iloprost IV-only and iloprost IV + tPA treatment groups, patients were treated with rapid rewarming of areas with frostbite, aspirin 250 mg IV, and buflomedil 400 mg IV. After randomization, patients continued to receive aspirin 250 mg IV daily for up to 8 days.2
IV=intravenous; tPA=tissue plasminogen activator.
AURLUMYN dosing and administration2
DAY 1
Initiate the infusion at a rate of 0.5 ng/kg/min; increase in increments of 0.5 ng/kg/min every 30 minutes based on tolerability, up to 2 ng/kg/min.
DAYS 2-3
Repeat the dose titration steps described for Day 1.
DAYS 4-8
Initiate the infusion at the highest tolerated dose from Day 3; adjust the rate as needed based on tolerability.
DAY 1
Initiate the infusion at a rate of 0.5 ng/kg/min; increase in increments of 0.5 ng/kg/min every 30 minutes based on tolerability, up to 2 ng/kg/min.
DAYS 2-3
Repeat the dose titration steps described for Day 1.
DAYS 4-8
Initiate the infusion at the highest tolerated dose from Day 3; adjust the rate as needed based on tolerability.
How to prepare2
Dilute in 3 simple steps:
- Withdraw 1 mL (100 mcg) of AURLUMYN solution from vial
- Transfer into 100 mL of 0.9% sodium chloride injection, USP polyvinyl chloride (PVC) infusion bag to make a final concentration of 1 mcg/mL (1000 ng/mL)
- Gently mix by slowly inverting the infusion bag—do not shake
USP=United States Pharmacopeia.
Important reminders1,2
- Initiate treatment immediately after rewarming. While AURLUMYN should be administered as soon as possible, data support a 48- and possibly up to 72-hour treatment-initiation window after rewarming‡
- Avoid inadvertent administration of a bolus of the drug. Do not flush the catheter without withdrawing residual drug from the catheter system. Discard any unused portion
- Because prostacyclin is commonly associated with headache and nausea, patient education around expectations can support tolerance
- Dosing can be titrated up or down based on tolerability and can be adjusted back down or up as needed
- Note: Iloprost IV has a half-life of 20 to 30 minutes
- Adverse reactions such as headache, flushing, jaw pain, myalgia, nausea, and vomiting may be dose limiting. If dose-limiting adverse reactions that cannot be tolerated by the patient occur, decrease the dose by 0.5 ng/kg/min every 30 minutes until the dose is tolerated. If a dose-limiting adverse reaction occurs at the starting dose, discontinue infusion. Infusion can be reinitiated at a previously tolerated dose/infusion rate once the event has resolved
‡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.3
Dosing instructions for patients with hepatic or renal impairment2
- In patients with moderate or severe hepatic impairment (Child-Pugh Class B or C): Initiate dose at 0.25 ng/kg/min for 30 minutes, then continue titration in 0.5 ng/kg/min increments every 30 minutes, according to tolerability, to a maximum dose of 2 ng/kg/min
- Dose adjustment is not required in patients with renal impairment who have an eGFR less than 30 mL/min: Initiate and titrate dosing per recommended dosage
- If the patient cannot tolerate the starting dose of 0.5 ng/kg/min, the dose can be lowered to 0.25 ng/kg/min
- The effect of dialysis on AURLUMYN exposure has not been evaluated
eGFR=estimated glomerular filtration rate.
Additional administration details2
- Administer IV infusion through a peripheral line or peripherally inserted central catheter using an infusion pump
- Use an infusion set with an in-line 0.22- or 0.2-micron filter
- Administer diluted AURLUMYN with an infusion pump that can deliver rates of 0.1 to 99.9 mL per hour (see Prescribing Information for more details)
Looking for more information?
Get the answers to frequently asked questions about AURLUMYN.
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.
- 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.
- 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.
- Pandey P, Vadlamudi R, Pradhan R, Pandey KR, Kumar A, Hackett P. Case report: severe frostbite in extreme altitude climbers—the Kathmandu iloprost experience. Wilderness Environ Med. 2018;29(3):366-374.
