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New FDA Drug Approvals - June 2024


iloprost

Aurlumyn

Pharmaceutical company: Eicos Sciences

Pharmacologic classification: Prostacyclin mimetic

Therapeutic classification: Vasodilator

AVAILABLE FORMS

Injection: 100 mcg/mL single-dose vial

INDICATIONS AND DOSAGES

Severe frostbite to reduce the risk of digit amputations

Adults: Continuous IV infusion over 6 hours daily for up to 8 consecutive days. Initially, 0.5 nanograms/kg/min IV infusion. Increase in increments of 0.5 nanograms/kg/min every 30 min, as tolerated, to maximum of 2 nanograms/kg/min. Repeat dose titration on days 2 and 3. From day 4 onward, start the infusion at the highest tolerated dose from the previous day, and adjust the rate as needed based on tolerability.

Adjust-a-dose: For patients with Child-Pugh class B or C liver impairment, initiate infusion at 0.25 nanograms/kg/min for 30 min, then titrate in 0.5 nanograms/kg/min increments every 30 min, as tolerated, to a maximum of 2 nanograms/kg/min. For patients with an estimated GFR less than 30 mL/min, initiate and titrate dosing as recommended. If the patient cannot tolerate the starting rate of 0.5 nanograms/kg/min, decrease to 0.25 nanograms/kg/min. If dose-limiting adverse reactions occur that cannot be tolerated, decrease the rate by 0.5 nanograms/kg/min every 30 min until tolerated. If a dose-limiting adverse reaction occurs during administration at the starting dose, discontinue the infusion and attempt reinitiation after the event has resolved or has been treated. If infusion is stopped at any point for a dose-limiting adverse event, reinitiate the infusion at a previously tolerated rate once the event has resolved. The maximum tolerated rate should be maintained for the remaining 6-hour daily infusion.

CONTRAINDICATIONS AND CAUTIONS

  • May cause symptomatic hypotension.
  • Use cautiously in patients with liver impairment.
  • Safety and efficacy in children have not been established.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • There are no available data on the use of this drug during pregnancy.
  • There are no data on the presence of iloprost in human milk or its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions, breastfeeding should be avoided during treatment.

INTERACTIONS

Drug-drug. Antihypertensives, vasodilators: May cause additive hypotensive effects. Consider temporary discontinuation of concomitant vasodilator or other antihypertensive medications during iloprost administration.

ADVERSE REACTIONS

CNS: headache, dizziness.
CV: flushing, palpitations, tachycardia, hypotension.
GI: nausea, vomiting.
Musculoskeletal: jaw pain, myalgia.

Reactions in bold italics are life-threatening.
 

Released: June 2024

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© 2024 Wolters Kluwer


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