pharmacopeia
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/api/v1/drug/iloprost

Mechanism of action

Sourced from openFDA

Iloprost is a synthetic analog of prostacyclin PGI 2 . Iloprost is a vasodilator and inhibits platelet aggregation.

Prostacyclin Receptor

Indications

Sourced from openFDA
  • 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 ( 1.1 ).

Contraindications

Sourced from openFDA
  • None. None ( 4 ).contraindicated

Dosage & administration

Sourced from openFDA

Initiate intravenous infusion at 0.5 ng/kg/minute and titrate in 0.5 ng/kg/minute increments based on tolerability at intervals of 30 minutes to a maximum of 2 ng/kg/minute ( 2.1 ). Administer as continuous infusion for 6 hours each day up to a maximum of 8 consecutive days ( 2.1 ). Patients with moderate or severe hepatic impairment (Child-Pugh Class B or C): initiate infusion at 0.25 ng/kg/minute and titrate as described above ( 2.3 ). Patients with renal impairment with eGFR less than 30 mL/min: initiate infusion at 0.5 ng/kg/minute and titrate as described above. If the patient cannot tolerate the starting dose of 0.5 ng/kg/minute, the dose can be decreased to 0.25 ng/kg/minute ( 2.4 ). See Full Prescribing Information for instructions on preparation and administration ( 2.2 ). 2.1 Recommended Dosage Monitor vital signs prior to the start of the infusion and with every dose increase. Administer AURLUMYN as a continuous intravenous infusion over 6 hours each day for up to a maximum of 8 consecutive days. Start the initial infusion on day 1 at a rate of 0.5 ng/kg/minute and increase in increments of 0.5 ng/kg/minute every 30 minutes according to tolerability up to 2 ng/kg/minute. Dosage is based on actual patient body weight (kg). Repeat dose titration steps on day 2 and day 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. Adverse reactions such as headache, flushing, jaw pain, myalgia, nausea, and vomiting may be dose-limiting.

Warnings & precautions

Sourced from openFDA

AURLUMYN may cause symptomatic hypotension. Monitor vital signs while initiating AURLUMYN. Correct hypotension prior to administration of AURLUMYN ( 5.1 ). 5.1 Hypotension AURLUMYN is a systemic vasodilator and may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN. Consider temporary discontinuation of concomitant vasodilator or other antihypertensive medications while administering AURLUMYN to reduce potential additive hypotensive effects. Consider down-titration or discontinuation of AURLUMYN if hypotension persists despite discontinuation of other antihypertensives and fluid resuscitation.

Adverse reactions

Sourced from openFDA

Most common adverse events include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension (6.1). To report SUSPECTED ADVERSE REACTIONS, contact BTG International, Inc. at 1-877-377-3748 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse events reported with the use of intravenous iloprost in patients with frostbite from the published literature include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension. Pre-marketing safety data on AURLUMYN were obtained from 116 patients with Systemic Sclerosis receiving iloprost in 2 multicenter, double-blind, randomized, placebo-controlled studies in patients with Systemic Sclerosis experiencing symptomatic digital ischemic episodes (Raynaud's Phenomenon). Patients received intravenous AURLUMYN administered as a continuous infusion over 6 hours each day for 5 consecutive days and the dose was adjusted according to individual tolerability within the range of 0.5 to 2.0 ng /kg /min. The observed safety profile in these patients was similar to that observed with IV iloprost.

Use in specific populations

Sourced from openFDA

Lactation: Advise not to breastfeed ( 8.2 ). 8.1 Pregnancy Risk Summary There are no available data with AURLUMYN during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are limited published cases of inhaled iloprost use during pregnancy, primarily during the second and third trimesters, that have not identified a drug-associated risk of adverse maternal or fetal outcomes. In animal reproductive studies, administration of continuous intravenous iloprost to pregnant Han-Wistar rats during organogenesis at doses 2-times the maximum recommended human dose on a mg/m 2 basis resulted in adverse developmental outcomes. However, there were no adverse developmental outcomes with oral or intravenous administration of iloprost to pregnant Sprague-Dawley rats, rabbits, and monkeys at doses 1111-, 1061-, and 12-times, respectively, the maximum recommended human dose by Cmax ( see Data ). The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
General Iloprost administered intravenously has linear pharmacokinetics over the dose range of 1 to 3 ng/kg/min. The half-life of iloprost is 20 to 30 minutes.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Feb 13, 2024NDANDA217933Btg Intl

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
892 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective11713%
  2. 2Death778.6%
  3. 3Off Label Use738.2%
  4. 4Dyspnoea707.8%
  5. 5Condition Aggravated657.3%
  6. 6Right Ventricular Failure637.1%
  7. 7Pulmonary Arterial Hypertension586.5%
  8. 8Hypotension515.7%
  9. 9Pulmonary Hypertension404.5%
  10. 10Headache384.3%
  11. 11Pneumonia374.1%
  12. 12Maternal Exposure During Pregnancy353.9%
  13. 13Premature Baby353.9%
  14. 14Sepsis353.9%
  15. 15Cardiac Failure333.7%

Literature

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Recent PubMed references pinned to Iloprost as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 108 ClinicalTrials.gov registrations naming Iloprost as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Iloprost work?
Iloprost is a synthetic analog of prostacyclin PGI 2 . Iloprost is a vasodilator and inhibits platelet aggregation.
What is Iloprost used for?
According to FDA labeling, Iloprost carries indications including: 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 ( 1.1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Iloprost?
Iloprost is classified as Platelet aggregation inhibitors excl. heparin, Prostacycline, Prostacyclin Receptor Agonists, Pulmonary Arterial Vasodilation, Systemic Arterial Vasodilation.
What are the brand names for Iloprost?
Iloprost is marketed under brand names including Aurlumyn, Ventavis.
What are the contraindications for Iloprost?
Iloprost labeling lists contraindications including: None. None ( 4 ).. Always consult the full prescribing information and a clinician.
Note. Data for iloprost is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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