Aurlumyn

Aurlumyn (iloprost) is a prostacyclin mimetic that is given by intravenous (into the vein) infusion and may be used to treat adults with severe frostbite to reduce the risk of digit amputations (surgical removal of fingers and toes).

Aurlumyn (iloprost) works by binding with equal affinity to human prostacyclin (Prostanoid IP) and prostaglandin EP1 receptors and acts as a vasodilator, relaxing the muscles in artery walls. This improves blood flow to the arteries, relieves high blood pressure, and inhibits platelet aggregation. Iloprost is a synthetic analog of prostacyclin PGI2.

The effectiveness of Aurlumyn was determined by an open-label, randomized controlled trial that involved 47 patients, mean age 33 years, 94% were men. 70% had frostbite involving the feet, 62% had frostbite involving the hands, and 32% had frostbite involving both feet and hands. Those assigned to the groups that received iloprost IV for 6 hours daily for up to 8 days were reported to have a significantly lower presence of bone scintigraphy anomaly (a marker that is expected to predict the risk of amputation) than those assigned to received buflomedil 400 mg IV for up to 8 days.

Aurlumyn was FDA-approved on February 14th, 2024.

May cause low blood pressure (hypotension) with symptoms such as dizziness (especially on standing), blurred vision, or confusion. Your healthcare provider should correct any preexisting hypotension, monitor your vital signs while administering Aurlumyn, and consider temporarily discontinuing any antihypertensive medications before administration.

Tell your doctor if you have:

• Low blood pressure
• Liver disease
• Renal disease
• Are pregnant
• Are breastfeeding.

Pregnancy and breastfeeding

No studies have been conducted on pregnant or breastfeeding women. Do not breastfeed.

The most common side effects include headache, flushing, heart palpitations, fast heart rate (tachycardia), nausea, vomiting, dizziness, and low blood pressure (hypotension)

To report suspected adverse reactions contact Eicos Sciences, Inc. at 1-844-456-7767 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Aurlumyn is administered as an intravenous infusion.

• The initial recommended starting rate is 0.5 ng/kg/minute which should be titrated in 0.5 ng/kg/minute increments based on tolerability at intervals of 30 minutes to a maximum of 2 ng/kg/minute.
• Should be administered as a continuous infusion for 6 hours each day up to a maximum of 8 consecutive days.
• The initial infusion rate should be reduced in moderate or severe hepatic impairment (Child-Pugh Class B or C) to 0.25 ng/kg/minute and titrated as described above.
• In patients with renal impairment (eGFR less than 30 mL/min) who cannot tolerate a starting dose of 0.5 ng/kg/minute, reduce the dose to 0.25 ng/kg/minute.

Consider down titration or discontinuation of Aurlumyn if hypotension persists despite discontinuation of other antihypertensives and fluid resuscitation.

Avoid standing or sitting up quickly from a lying position because Aurlumyn may cause your blood pressure to fall and you may become dizzy.

Store unopened vials at 20°C to 25°C (68°F to 77°F).

Keep the unopened vial in the carton do not expose it to direct sunlight. Do not freeze.

Active: iloprost 100 mcg per mL

Inactive: 8.1mg ethanol, 0.9 mg sodium chloride, and 0.242 mg tromethamine. Hydrochloric acid and sodium hydroxide are added to adjust pH to 8.3.

The solution contains no preservatives.

Available as a single-dose glass vial per carton.

Eicos Sciences Inc.