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Prostacyclin Analogue

Iloprost (IV/Inhaled)

Brand names: Ilomedin, Ventavis

Iloprost is a synthetic prostacyclin analogue given by intravenous infusion or by nebuliser, used in pulmonary arterial hypertension and for severe peripheral ischaemia such as critical limb ischaemia and Raynaud's complications.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: INTRAVENOUS (the peripheral-vascular route, US AURLUMYN label): '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'; 'Administer AURLUMYN as a continuous intravenous infusion over 6 hours each day for up to a maximum of 8 consecutive days.' INHALED (pulmonary hypertension, UK Ventavis SPC): 'the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser. If this dose is well tolerated, dosing should be increased to 5 microgram iloprost and maintained at that dose. In case of poor tolerability of the 5 microgram dose, the dose should be reduced to 2.5 microgram iloprost.'
Route: Intravenous continuous infusion by pump through a peripheral line or PICC, using an infusion set with an in-line 0.22- or 0.2-micron filter (AURLUMYN); or inhalation by nebuliser - Ventavis is licensed only with the Breelib, I-Neb AAD or Venta-Neb devices ('The efficacy and tolerability of inhaled iloprost when administered with other nebulising systems... have not been established').
Frequency: IV: one 6-hour continuous infusion each day, for up to 8 consecutive days - '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.' INHALED: 'The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.'
WHY maxDose IS EMPTY: the IV ceiling in the source is a per-kg infusion RATE ('a maximum of 2 ng/kg/minute'), not an absolute dose ceiling, and the other US limit ('up to a maximum of 8 consecutive days') is a duration; the inhaled SPC states no maximum dose at all. Both are recorded here instead. INDICATION SCOPE: the bundle carries no indications section for AURLUMYN; the clinical populations named in its retrieved sections are frostbite ('Adverse events reported with the use of intravenous iloprost in patients with frostbite from the published literature') and 'patients with Systemic Sclerosis experiencing symptomatic digital ischemic episodes (Raynaud's Phenomenon)' - peripheral ischaemia, matching this vascular page - while the inhaled Ventavis SPC is a pulmonary hypertension product ('Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension'). DOSE IS BY ACTUAL BODY WEIGHT for the IV route. PREPARATION (US label): the vial is 100 mcg per mL; 'Withdraw 1 mL (100 mcg) of AURLUMYN solution from the vial and transfer into 100 mL of 0.9% Sodium Chloride Injection, USP polyvinyl chloride (PVC) infusion bag to make a final concentration of 1 mcg/mL (1,000 ng/mL)'; dilute only in 0.9% sodium chloride, use immediately or within 4 hours at room temperature, and 'Infusion Rate (mL/hr) = [Dose (ng/kg/min) x Weight (kg) x 60 min/hr] / Final Concentration (1,000 ng/mL)'. 'Avoid inadvertent administration of a bolus of the drug.' DOSE-LIMITING REACTIONS: 'headache, flushing, jaw pain, myalgia, nausea, and vomiting may be dose-limiting... decrease the dose in a stepwise manner by 0.5 ng/kg/min every 30 minutes, until a tolerated dose is reached.' INHALED DEVICE DETAIL: with Breelib the 2.5 microgram dose comes from a 1 ml ampoule of Ventavis 10 microgram/ml and the 5 microgram dose from Ventavis 20 microgram/ml; with I-Neb AAD both doses come from a 1 ml ampoule of the 10 microgram/ml solution (red chamber/disc for 2.5 microgram, ~3.2 min; purple for 5 microgram, ~6.5 min); with Venta-Neb a 2 ml ampoule is used (P2 = 2.5 microgram over 10 inhalation cycles, ~4 min; P1 = 5 microgram over 25 cycles, ~8 min). 'Patients stabilised on one nebuliser should not switch to another nebuliser without supervision by the treating physician.' NOT SOURCED: the existing page entry's IV duration of '5-28 days' is NOT in this bundle - the US label caps continuous daily infusion at 8 consecutive days (its systemic sclerosis studies used 5 consecutive days). PAEDIATRIC: no dose exists in either source - 'The safety and efficacy of Ventavis in children aged up to 18 years have not been established. No data from controlled clinical trials are available' and 'Safety and efficacy in pediatric patients have not been established' - so paedDose is null. ELDERLY (US label): 'dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range'.

Dose adjustments

Renal

INHALED (eMC §4.2): 'There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula). Patients with a creatinine clearance of <=30 ml/min were not investigated in the clinical trials. Data with intravenously administered iloprost indicated that the elimination is reduced in patients with renal failure requiring dialysis. Therefore, the same dosing recommendations as in patients with hepatic impairment (see above) are to be applied' - i.e. start at 2.5 microgram with 3-4 hour dosing intervals. INTRAVENOUS (US label §2.4): 'Patients with renal impairment with eGFR less than 30 mL/min: Initiate and titrate dosing per recommended dosage. If patient cannot tolerate the starting dose of 0.5 ng/kg/minute the dose can be lowered to 0.25 ng/kg/minute. The effect of dialysis on iloprost exposure has not been evaluated. For patients requiring intermittent hemodialysis, consider iloprost administration after the end of hemodialysis. Alternatively, hemodialysis can be started at least one hour after the end of iloprost infusion.'

Hepatic

INHALED (eMC §4.2): 'Iloprost elimination is reduced in patients with hepatic dysfunction... To avoid undesired accumulation over the day, special caution has to be exercised with these patients during initial dose titration. Initially, doses of 2.5 microgram iloprost should be administered using Ventavis 10 microgram/ml with dosing intervals of 3-4 hours (corresponds to administration of max. 6 times per day). Thereafter, dosing intervals may be shortened cautiously based on individual tolerability. If a dose up to 5 microgram iloprost is indicated, again dosing intervals of 3-4 hours should be chosen initially and shortened according to individual tolerability.' INTRAVENOUS (US label §2.3): 'Patients with moderate or severe hepatic impairment (Child-Pugh Class B or C): Initiate dosage at 0.25 ng/kg/minute for 30 minutes then continue titration in 0.5 ng/kg/minutes increments every 30 minutes according to tolerability to a maximum dose of 2 ng/kg/minute.'

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Conditions where the effects on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage)
  • Severe coronary heart disease or unstable angina
  • Myocardial infarction within the last six months
  • Decompensated cardiac failure if not under close medical supervision
  • Severe arrhythmias
  • Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months
  • Pulmonary hypertension due to venous occlusive disease
  • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
  • Not a contraindication but a threshold from §4.4: 'Ventavis should not be initiated in patients with systolic blood pressure less than 85 mmHg'
  • NOTE ON THIS LIST: every item above is from the UK Ventavis (inhaled) SPC §4.3. The US intravenous label states '4 CONTRAINDICATIONS None.', so these do not carry the authority of the IV product's own labelling.

Side effects

  • Inhaled (Ventavis, very common >=1/10): vasodilatation, headache, cough, bleeding events, chest discomfort/chest pain, nausea, pain in jaw/trismus, peripheral oedema - 'The most frequently observed adverse reactions (>= 20 %) in clinical trials include vasodilatation (including hypotension), headache and cough'
  • Inhaled (common >=1/100 to <1/10): thrombocytopenia, dizziness, tachycardia, palpitations, flushing, syncope, hypotension, dyspnoea, pharyngolaryngeal pain, throat irritation, diarrhoea, vomiting, mouth and tongue irritation including pain, dysgeusia, rash
  • Bronchospasm/wheezing and hypersensitivity (frequency not known) - 'Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity'
  • 'The most serious adverse reactions were hypotension, bleeding events, and bronchospasm' - life-threatening and/or fatal cases have been reported for bleeding events, hypotension and bronchospasm; fatal bleeding cases included cerebral and intracranial haemorrhage
  • Bleeding events (mostly epistaxis and haemoptysis) were very common; 'The risk of bleeding may be increased in patients when potential inhibitors of platelet aggregation or anticoagulants are given concomitantly'
  • Intravenous (US label): 'Most common adverse events include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension' - the same list is reported for intravenous iloprost in frostbite in the published literature
  • NOTE ON THIS LIST: eMC §4.8 and the US §6.1 are both truncated at the source-fetch limit, so neither list is complete; peripheral oedema was reported in 12.2% of patients on iloprost versus 16.2% on placebo in the inhaled trials.

Monitoring

  • Blood pressure - 'Blood pressure should be checked while initiating Ventavis', and Ventavis 'should not be initiated in patients with systolic blood pressure less than 85 mmHg'; for the IV product, 'Monitor vital signs prior to the start of the infusion and with every dose increase' and 'Correct hypotension prior to administration'
  • Consider temporarily withholding other vasodilators or antihypertensives during IV treatment 'to reduce potential additive hypotensive effects', and consider down-titration or discontinuation of iloprost if hypotension persists despite that and fluid resuscitation
  • Syncope - the pulmonary vasodilatory effect lasts only one to two hours; 'The increased occurrence of syncope can reflect therapeutic gaps, insufficient effectiveness and/or deterioration of the disease. The need to adapt and/or change the therapy should be considered.'
  • Respiratory status - 'Patients with concomitant acute pulmonary infections, COPD and severe asthma should be carefully monitored'; if pulmonary oedema occurs, consider pulmonary veno-occlusive disease and discontinue
  • On stopping - 'the risk of rebound effect is not formally excluded. Careful monitoring of the patient should be performed, when inhaled iloprost therapy is stopped and an alternative treatment should be considered in critically ill patients'
  • Right heart failure - 'The use of Ventavis is not recommended in patients with unstable pulmonary hypertension, with advanced right heart failure. In case of deterioration or worsening of right heart failure transfer to other medicinal products should be considered.'
  • Inspect the vial before use and discard if the solution is discoloured or cloudy or foreign particles are present (US label)

Clinical monograph

How it works

As a prostacyclin (PGI2) analogue it causes potent vasodilatation and inhibits platelet aggregation, improving microcirculatory blood flow.

Prescribing in practice

  • It causes marked vasodilatation with hypotension, flushing and headache, so blood pressure must be monitored and the infusion titrated, with inhaled use requiring a dedicated nebuliser system.
  • It inhibits platelet function and increases bleeding risk, so use cautiously with anticoagulants and antiplatelet agents.
  • Avoid in conditions where its vasodilator and antiplatelet effects are hazardous, such as active bleeding, decompensated heart failure or unstable coronary disease.

Monitoring

Monitor blood pressure and heart rate closely during infusion or inhalation, and watch for syncope, flushing and headache.

Counselling the patient

  • Flushing, headache and jaw pain can occur as the infusion or inhalation runs.
  • Stand up slowly and report dizziness or fainting.

Evidence & guidelines

Established in pulmonary arterial hypertension and severe peripheral ischaemia through controlled trials and specialist vascular and respiratory guidelines.

Reference: EAU/BSR guidelines; ESOC Raynaud's guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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