Brand Name
Aurlumyn
Generic Name
Iloprost
View Brand Information FDA approval date: October 10, 2024
Classification: Prostacycline
Form: Injection
What is Aurlumyn (Iloprost)?
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.
Approved To Treat
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Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 ng/kg/Min) in Mechanically Ventilated Patients With Infectious Pulmonary Endotheliopathy - a Multicenter Randomized, Placebo-controlled, Blinded, Investigator-initiated Trial
Summary: The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore v...
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Brand Information
AURLUMYN (ILOPROST)
1DOSAGE FORMS AND STRENGTHS
Injection: 100 mcg per mL iloprost as a clear and colorless solution in a single-dose vial.
2CONTRAINDICATIONS
None.
3OVERDOSAGE
Cases of overdose of intravenous iloprost have not been reported. Hypotension, vomiting, and diarrhea are likely. A specific antidote is not known. Interruption of the infusion session, monitoring, and symptomatic measures are recommended.
4DESCRIPTION
AURLUMYN contains iloprost, a synthetic analog of prostacyclin PGI
AURLUMYN (iloprost) injection is a clear, colorless, sterile solution formulated for intravenous use. AURLUMYN is supplied in single-use glass vials containing 1-mL per vial. Each mL of the solution contains 100 mcg (0.1 mg) of iloprost as the active ingredient and the following inactive ingredients: 8.1 mg ethanol, 9 mg sodium chloride, and 0.242 mg tromethamine. Hydrochloric acid and sodium hydroxide is added to adjust pH to 8.3.
The solution contains no preservatives.
5HOW SUPPLIED/STORAGE AND HANDLING
AURLUMYN (iloprost) injection is a clear, colorless sterile solution supplied as 100 mcg per mL single-dose glass vial per carton (NDC 50633-340-01).
6PATIENT COUNSELING INFORMATION
Advise patients that they may have a fall in blood pressure with AURLUMYN, so they may become dizzy during drug administration. They should stand up slowly when they get out of a chair or bed.
7PRINCIPAL DISPLAY PANEL - NDC 50633-340-01 - Carton Label
8PRINCIPAL DISPLAY PANEL - NDC 50633-340-01 - Vial Label
