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Prostacyclin analogue (vasodilator) Pregnancy: CONTRAINDICATED in pregnancy and during breast-feeding. SPC §4.6, verbatim: 'Iloprost 100 micrograms/ml concentrate for solution for infusion is contraindicated during pregnancy (see section 4.3). Women of childbearing potential have to use effective contraception during treatment. There are no or limited amount of data from the use of iloprost in pregnant women. Studies in animals have shown embryotoxicity in rats but not in rabbits and monkey.' Breast-feeding: 'Iloprost 100 micrograms/ml concentrate for solution for infusion is contraindicated during breast-feeding (see section 4.3). It is unknown whether iloprost is excreted in human milk.' Fertility: 'There are no fertility data available.' §4.2 additionally requires that 'Pregnancy should be excluded before the start of treatment in women.' The US AURLUMYN label §8.1 is less restrictive — 'There are no available data with AURLUMYN during pregnancy...' — but it is a different product and does not override the UK contraindication.

Iloprost (IV/Nebulised)

Brand names: Ilomedine (IV), Ventavis (nebulised)

Iloprost is a synthetic prostacyclin (PGI2) analogue given intravenously or by inhalation, used in pulmonary arterial hypertension and in severe peripheral vascular disease such as critical limb ischaemia and digital ulceration in systemic sclerosis.

Adult dose

Dose: Severe chronic ischaemia of the lower limbs: 0.5 to 2 nanograms/kg/min by intravenous infusion over 6 hours per day, adjusted to individual tolerability (start at 0.5 nanograms/kg/min and increase every 30 minutes in 0.5 nanogram/kg/min steps to no more than 2.0 nanograms/kg/min)
Route: Intravenous infusion only, after dilution. SPC §4.2, verbatim: 'Iloprost 100 micrograms/ml concentrate for solution for infusion is administered after dilution as described in section 6.6 as an intravenous infusion over 6 hours via a peripheral vein or a central venous catheter.' The concentrate 'is NOT ready to use and requires dilution before administration' and 'should only be used diluted'. Two dilutions exist: 0.2 micrograms/ml, which 'may only be administered with an infusion pump (e.g. Infusomat)', and the 10-fold stronger 2 micrograms/ml, which 'may be administered via a syringe driver'. §4.4 requires 'a dedicated intravenous cannula... for the infusion of iloprost and the patency of the line should be checked during infusion'. Administration must be 'under strict monitoring in a hospital or out-patient clinic setting with adequate facilities'.
Frequency: One 6-hour infusion per day. SPC §4.2 (Treatment of severe chronic ischemia of the lower limbs), verbatim: 'The recommended dosage varies between 0.5 to 2 ng/kg/min for an infusion of 6h /per day depending on the patient's tolerance. Continue the treatment in general for four weeks, using the tolerated dose determined during the first two or three days of treatment. The duration of treatment is usually four weeks. It may be less in case of early efficacy.'
SCOPE: this covers the page's PRIMARY indication and route only — intravenous iloprost for severe chronic limb ischaemia. The page is also titled '(IV/Nebulised)' and its current entry carries a nebulised pulmonary-arterial-hypertension regimen; NO NEBULISED SPC IS IN THIS BUNDLE, so no inhaled dose, inhalation count or session duration is published or implied here. Source that product's SPC separately before restoring any nebulised figure. || WHY maxDose IS EMPTY: the only ceiling this SPC gives is a body-weight-based infusion RATE ('to a maximum of 2.0 ng/kg/min'), which is not an absolute dose ceiling; it is stated in the dose field and quoted below instead. || TITRATION, verbatim (§4.2 Posology): 'Blood pressure and heart rate should be monitored at the start of the infusion and subsequently at every dose increase. During the first 2-3 days, the individually tolerated dose is established. For this reason, treatment should be started at an infusion rate of 0.5 ng/kg/min for 30 minutes. The dose should then be increased at intervals of 30 minutes by 0.5 ng/kg/min to a maximum of 2.0 ng/kg/min. The exact infusion rate should be calculated on the basis of body weight to reach an infusion within the range of 0.5 to 2.0 ng/kg/min.' || TOLERABILITY, verbatim: 'Depending on the occurrence of adverse effects such as headache and nausea or an undesired blood pressure drop, the infusion rate should be reduced until the optimal tolerated dose is found. If the adverse effects are severe, the infusion should be temporarily interrupted. The treatment course can then be continued with the dose based on the optimal tolerated dose reached in the first 2 to 3 days of treatment.' || INFUSION-RATE TABLES (verbatim from §4.2). Table 1 — automatic infusion pump, 0.2 micrograms/ml dilution, infusion rate in ml/h at doses of 0.5 / 1.0 / 1.5 / 2.0 ng/kg/min: 40 kg 6.0 / 12 / 18.0 / 24; 50 kg 7.5 / 15 / 22.5 / 30; 60 kg 9.0 / 18 / 27.0 / 36; 70 kg 10.5 / 21 / 31.5 / 42; 80 kg 12.0 / 24 / 36.0 / 48; 90 kg 13.5 / 27 / 40.5 / 54; 100 kg 15.0 / 30 / 45.0 / 60; 110 kg 16.5 / 33 / 49.5 / 66. Table 2 — syringe driver with a 50 ml syringe (e.g. Perfusor), 2 micrograms/ml dilution: 40 kg 0.60 / 1.2 / 1.80 / 2.4; 50 kg 0.75 / 1.5 / 2.25 / 3.0; 60 kg 0.90 / 1.8 / 2.70 / 3.6; 70 kg 1.05 / 2.1 / 3.15 / 4.2; 80 kg 1.20 / 2.4 / 3.60 / 4.8; 90 kg 1.35 / 2.7 / 4.05 / 5.4; 100 kg 1.50 / 3.0 / 4.50 / 6.0; 110 kg 1.65 / 3.3 / 4.95 / 6.6. || DURATION LIMIT, verbatim: 'The duration of treatment is up to 4 weeks. The safety and efficacy... have not been studied after treatment longer than 4 weeks or after repetitive treatment cycles.' For limb ischaemia specifically: 'Continuous infusion over several days is not recommended. Although there were no clinical consequences, a tachyphylaxis of the effects on the platelets as well as a hyperaggregability at the stop of the treatment can occur.' || SECOND LICENSED INDICATION IN THE SAME SPC (a different indication — not this page's primary, and given here only so it is not mistaken for the limb-ischaemia regimen): 'Treatment of Severe Raynaud's Phenomenon. The recommended dosage varies between 1.5 to 2 ng/kg/min depending on the patient's tolerance... The duration of the infusion will be 6h/per day for 5 consecutive days... Repeat cycles should preferably take place at intervals of 6 to 12 weeks (and never less than 4 weeks).' || PREPARATION: 'The infusion solution should be made up just before the infusion to ensure sterility... To avoid incompatibility, no other products should be added to the infusion prepared for injection. The content of the ampoule and the diluent must be mixed thoroughly.' Pregnancy must be excluded before starting treatment in women (§4.2). || US CROSS-CHECK — DIFFERENT PRODUCT, DIFFERENT REGIMEN, NOT USED FOR THE FIGURES ABOVE: AURLUMYN §2.1 also initiates at 0.5 ng/kg/minute and titrates in 0.5 ng/kg/minute steps every 30 minutes to a maximum of 2 ng/kg/minute over a 6-hour daily infusion, but limits the course to 'a maximum of 8 consecutive days' and repeats the titration on days 2 and 3, then 'From day 4 onward, start the infusion at the highest tolerated dose from the previous day'. Its dilution is different (1 mL/100 mcg into 100 mL of 0.9% sodium chloride to give 1 mcg/mL) and it requires an in-line 0.22- or 0.2-micron filter. Its §6.1 describes adverse events 'reported with the use of intravenous iloprost in patients with frostbite from the published literature' and pre-marketing data from 116 patients with systemic sclerosis — i.e. a different labelled population from the UK limb-ischaemia indication. || PAEDIATRIC: SPC §4.2, verbatim: 'Safety and efficacy of Iloprost 100 micrograms/ml concentrate for solution for infusion in children aged up to 18 years have not been established.' US §8.4: 'Safety and efficacy in pediatric patients have not been established.' paedDose is therefore null; verify any under-18 use against a children's formulary and specialist advice.

Dose adjustments

Renal

SPC §4.2 (Special population — Renal or hepatic impairment), verbatim: 'In patients with renal insufficiency requiring dialysis or severe hepatic impairment, caution initial titration with a reduced dose is required (e.g. half the normal dose see Section 4.4 and 5.2).' §4.4 adds, verbatim: 'In patients with renal insufficiency requiring dialysis or severe hepatic impairment, it should be taken into account that iloprost plasma levels may be increased due to less elimination of the product... In these patients, cautious initial titration with dose reduction (see section 4.2) and close clinical monitoring are required.' US AURLUMYN §2.4 (different product, for cross-reference only): '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

SPC §4.2, verbatim: 'In patients with renal insufficiency requiring dialysis or severe hepatic impairment, caution initial titration with a reduced dose is required (e.g. half the normal dose see Section 4.4 and 5.2).' §4.4: plasma levels may be increased because of reduced elimination, so cautious initial titration with dose reduction and close clinical monitoring are required. US AURLUMYN §2.3 (different product, for cross-reference only): '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 independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. 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 (SPC §4.3)
  • Pregnancy (SPC §4.3)
  • Lactation / breast-feeding (SPC §4.3)
  • Conditions where the effects of iloprost on platelets might increase the risk of haemorrhage — e.g. active peptic ulcer, trauma, intracranial haemorrhage (SPC §4.3)
  • Severe coronary heart disease or unstable angina (SPC §4.3)
  • Myocardial infarction within the last six months (SPC §4.3)
  • Decompensated cardiac failure if not under close medical supervision (SPC §4.3)
  • Acute or chronic congestive heart failure (NYHA II-IV) (SPC §4.3)
  • Severe arrhythmias (SPC §4.3)
  • Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months (SPC §4.3)
  • Pulmonary oedema (SPC §4.3)
  • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension (SPC §4.3)
  • Note: the US AURLUMYN label §4 states 'None.' — the contraindication list above is the UK SPC's and is the one that applies to this product

Side effects

  • Very common (≥1/10): headache, flushing, nausea, vomiting and hyperhidrosis — SPC §4.8: 'The most common observed adverse events (≥ 10%) in patients receiving iloprost in clinical trials are headache, flushing, nausea, vomiting and hyperhidrosis. These undesirable effects are likely to occur during the dose titration at the start of treatment... Usually these undesirable effects resolve with dose reduction.'
  • Most severe (life-threatening or fatal) reactions, verbatim §4.8: 'cerebrovascular stroke, myocardial infarction, pulmonary embolism, cardiac failure, convulsion, hypotension, tachycardia, asthma, angina pectoris, dyspnoea, and pulmonary oedema'
  • Infusion-site reactions: 'infusion site redness and infusion site pain may occur or a cutaneous vasodilation may give rise to a linear erythema above the infusion vein' (§4.8)
  • Blood: thrombocytopenia. Immune: hypersensitivity. Metabolism: decreased appetite (§4.8 Table 1)
  • Psychiatric: bradypsychia, confusional state, apathy; anxiety, depression, hallucination (§4.8 Table 1)
  • Nervous system: headache (very common); dizziness/vertigo, paraesthesia, hyperaesthesia, burning sensation, restlessness/drowsiness, pulsatile sensation, nervousness; convulsion, syncope, tremor, migraine (§4.8 Table 1)
  • Eye: blurred vision, eye irritation, eye pain. Cardiac: tachycardia, bradycardia (§4.8 Table 1 — the table is truncated at the source-fetch limit beyond this point, so this is not the complete adverse-reaction table)
  • US AURLUMYN §6 (different product, cross-reference): 'Most common adverse events include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension'; §5.1 warns it 'is a systemic vasodilator and may cause symptomatic hypotension'

Monitoring

  • Blood pressure and heart rate at the start of the infusion and at every dose increase — SPC §4.2, verbatim: 'Blood pressure and heart rate should be monitored at the start of the infusion and subsequently at every dose increase.'
  • Administer only 'under strict monitoring in a hospital or out-patient clinic setting with adequate facilities' (§4.2)
  • Check the dedicated intravenous cannula and the patency of the line during the infusion; accidental infusion of undiluted iloprost may cause local changes at the injection site (§4.4)
  • Watch for hypotension in patients with low blood pressure, and for orthostatic hypotension 'in patients getting up from the lying to an upright position after the end of administration'; monitor patients with significant heart disease closely (§4.4)
  • Exclude pregnancy before starting treatment in women (§4.2); women of childbearing potential must use effective contraception during treatment (§4.6)
  • Do not delay surgery in patients requiring urgent amputation, e.g. for infected gangrene; strongly advise smokers to stop (§4.4)
  • Undertake a careful benefit-risk assessment in patients who have had a cerebrovascular event, because of the haemorrhage risk (§4.4)
  • US AURLUMYN §5.1 (cross-reference): 'Monitor vital signs while initiating' and 'Correct hypotension prior to administration'

Clinical monograph

How it works

It mimics prostacyclin to cause vasodilatation of pulmonary and systemic arterial beds and to inhibit platelet aggregation.

Prescribing in practice

  • Potent vasodilatation can cause hypotension, flushing, headache and syncope, so blood pressure must be monitored closely during infusion or inhalation and the dose titrated to tolerance.
  • Use with caution in patients at increased risk of bleeding given its antiplatelet effect, and in those with unstable cardiac disease.
  • Inhaled administration requires a suitable nebuliser system and the patient should be seated; treatment is specialist-initiated.

Monitoring

Monitor blood pressure, heart rate and for vasodilatory adverse effects during and after each administration.

Counselling the patient

  • Headache, flushing and jaw pain are common and usually settle with continued use.
  • Stand up slowly and report dizziness or fainting.
  • Do not stop pulmonary hypertension treatment abruptly without specialist advice.

Evidence & guidelines

Iloprost is recommended for pulmonary arterial hypertension and is supported by evidence in systemic-sclerosis-related digital ischaemia.

Reference: EULAR Scleroderma Guidelines; ESC PAH 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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