AURLUMYN is the first and only FDA-approved treatment option for severe frostbite in adults to reduce the risk of digit amputation 

Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes. 

FORMULARY TOOLKIT

The formulary resources listed below have been provided to assist healthcare decision makers with information needed to learn more about AURLUMYN.

Key Product Information

Prescribing Information Thumbnail

Prescribing Information

The most current full Prescribing Information for AURLUMYN.

Press Release Thumbnail

Commercial Availability Press Release

Press release sharing the commercial availability of AURLUMYN for use in the U.S.

Formulary Toolkit Resources

Aurlumyn Formulary Presentation Thumbnail

Formulary Presentation

Outlines the value and supporting clinical data behind AURLUMYN as a treatment for severe frostbite.

AURLUMYN Product Monograph

Product Monograph

Provides key information about AURLUMYN’s efficacy and safety data, clinical pharmacology, dosing and administration, and other important product details to help guide formulary decisions and inform end users.

Aurlumyn Dossier

AMCP Dossier (Available by request only)

This document provides information on the clinical and economic aspects of AURLUMYN, leveraging clinical data and the FDA-approved label.

Published Literature

Aurlumyn Bibliography

Bibliography

Provides literature relevant to AURLUMYN and its supporting clinical data (eg, peer-reviewed articles, guideline recommendations) and includes frostbite-related literature for context.

Distribution, Pricing and Reimbursement Information

Aurlumyn Product Fact Sheet Thumbnail

Ordering, Pricing and Distribution Fact Sheet

Lists practical AURLUMYN ordering, pricing, and distribution details. Includes NDC, WAC pricing, storage, and handling information. 

Aurlumyn Reimbursement and Coding Thumbnail

Reimbursement and Coding Guide

Provides information to help with AURLUMYN reimbursement, including key product information and potential diagnosis codes. Provides background on how new technology add-on payments (NTAP) and outlier payments may offset treatment expenses.

FDA, US Food and Drug Administration; NDC, National Drug Code; rt-PA, recombinant tissue plasminogen activator; WAC, wholesale acquisition cost.

References
1.

AURLUMYN. Prescribing information. Eicos Sciences Inc.; 2024. Accessed December 2, 2024. https://aurlumyn.com/sites/aurlumyn-library/files/2024-11/PI_Aurlumyn_iloprost_label_May2024.pdf

INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION

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 us at 1-877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Please see full Prescribing Information for AURLUMYN.