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Prostacyclin Analogue — Vasodilator and Antiplatelet 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 (see section 5.3).' 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. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from... therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.' Fertility: 'There are no fertility data available.' §4.2 also requires that 'Pregnancy should be excluded before the start of treatment in women.'

Iloprost (Raynaud's / Systemic Sclerosis)

Brand names: Ilomedin, Ventavis

This is intravenous iloprost used in rheumatology for severe Raynaud's phenomenon and digital ischaemia complicating systemic sclerosis and other connective tissue diseases, typically given as a hospital-supervised infusion over several consecutive days.

Adult dose

Dose: Severe Raynaud's phenomenon: 1.5 to 2 nanograms/kg/min by intravenous infusion, reached by starting at 0.5 nanograms/kg/min and increasing gradually every 30 minutes to the maximum dose the patient tolerates
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'. The 0.2 micrograms/ml dilution 'may only be administered with an infusion pump (e.g. Infusomat)'; the 2 micrograms/ml dilution 'may be administered via a syringe driver'. §4.4: use a dedicated intravenous cannula and check the patency of the line during the infusion. Administration must be 'under strict monitoring in a hospital or out-patient clinic setting with adequate facilities'.
Frequency: 6 hours per day for 5 consecutive days per cycle. SPC §4.2, verbatim: 'The duration of the infusion will be 6h/per day for 5 consecutive days, using the maximum tolerated dose determined during the first days of treatment. Repeat cycles should preferably take place at intervals of 6 to 12 weeks (and never less than 4 weeks).'
SCOPE: this is the SPC's own 'Treatment of Severe Raynaud's Phenomenon' regimen — the page's primary indication and route. The SPC does NOT give a separate dose for systemic sclerosis digital ULCERS, for critical digital ischaemia, or for prevention of new ulcers; those are not published here and must not be inferred from the Raynaud's figures. || WHY maxDose IS EMPTY: the ceiling in this SPC is a body-weight-based infusion RATE ('to a maximum of 2.0 ng/kg/min'), not an absolute dose ceiling; it is carried in the dose field and quoted below instead. || VERBATIM (§4.2, Treatment of Severe Raynaud's Phenomenon): 'The recommended dosage varies between 1.5 to 2 ng/kg/min depending on the patient's tolerance. Treatment should be started at 0.5 ng/kg/min (i.e. 10 ml / h) and increased gradually every 30 minutes, according to the scheme proposed above, to reach the maximum tolerated dose by the patient. The duration of the infusion will be 6h/per day for 5 consecutive days, using the maximum tolerated dose determined during the first days of treatment. Repeat cycles should preferably take place at intervals of 6 to 12 weeks (and never less than 4 weeks).' The parenthetical '10 ml / h' is the SPC's own worked figure; the SPC's Table 1 (0.2 micrograms/ml pump dilution) gives 10.5 ml/h at 0.5 ng/kg/min for a 70 kg patient, so always set the rate from the tables or from body weight rather than from that single figure. || GENERAL TITRATION SCHEME REFERRED TO ABOVE (§4.2 Posology, verbatim): '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 (§4.2, 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.' || INFUSION-RATE TABLES (verbatim, §4.2). Table 1 — automatic infusion pump, 0.2 micrograms/ml, ml/h at 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, ml/h at the same doses: 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. || THE OTHER INDICATION IN THIS SPC — DIFFERENT REGIMEN, DO NOT MIX UP: 'Treatment of severe chronic ischemia of the lower limbs. 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... The duration of treatment is usually four weeks.' That course runs for about four weeks, not five days, and its target range starts lower. || PREPARATION: 'The infusion solution should be made up just before the infusion to ensure sterility... no other products should be added to the infusion prepared for injection.' Pregnancy must be excluded before starting treatment in women (§4.2). Overall SPC duration statement: '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.' || PAEDIATRIC (§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.' 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, 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 (see section 5.2). In these patients, cautious initial titration with dose reduction (see section 4.2) and close clinical monitoring are required.' No creatinine-clearance thresholds are given in this SPC.

Hepatic

Severe hepatic impairment is handled by the same SPC sentence as renal impairment: §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 explains that iloprost plasma levels may be increased because of less elimination, so cautious initial titration with dose reduction and close clinical monitoring are required. No Child-Pugh thresholds are given in this SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — 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)

Side effects

  • Very common (≥1/10): headache, flushing, nausea, vomiting and hyperhidrosis. SPC §4.8, verbatim: 'These undesirable effects are likely to occur during the dose titration at the start of treatment to identify the best tolerable dose for the individual patient. 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 and lymphatic: 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, palpitations, 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)
  • Skin contact hazard rather than a systemic reaction (§4.4): 'On contact with the skin, iloprost may cause long-lasting but painless erythema' — wash the area immediately with copious water or saline

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)
  • Use a dedicated intravenous cannula and check the patency of the line during infusion — accidental infusion of undiluted iloprost may result in local changes at the injection site (§4.4)
  • Watch for hypotension in patients with low blood pressure and for orthostatic hypotension on standing after the infusion ends; 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)
  • Careful benefit-risk assessment in patients who have had a cerebrovascular event, because of the haemorrhage risk (§4.3/§4.4)
  • Do not delay surgery in patients requiring urgent amputation, e.g. for infected gangrene; strongly advise smokers to stop (§4.4)
  • Watch for additive hypotension when combined with beta-blockers, calcium antagonists, vasodilators or ACE inhibitors — §4.5: 'If, in a patient treated with such a combination, hypotension occurs during the infusion, the corrective measure to be taken will be to reduce the infusion rate or even to stop the infusion or the associated treatment.' Bleeding risk is increased with anticoagulants, heparin, thrombolytics and other antiplatelet agents (§4.5, truncated at the source-fetch limit)

Clinical monograph

How it works

Iloprost is a synthetic prostacyclin (PGI2) analogue that produces vasodilatation and inhibits platelet aggregation, improving peripheral and digital blood flow.

Prescribing in practice

  • Dose-related hypotension, flushing, headache, nausea and jaw or muscle pain are common during infusion, so the rate is titrated to tolerability with blood pressure monitoring.
  • It is contraindicated in conditions where vasodilatation or its antiplatelet effect would be hazardous, such as decompensated heart failure, recent myocardial infarction or active bleeding.
  • Caution and rate review are needed with antihypertensives, anticoagulants and antiplatelets owing to additive effects.

Monitoring

Monitor blood pressure and heart rate closely throughout each infusion and titrate the rate against vasodilatory side effects as set out in the SPC.

Counselling the patient

  • Headache and flushing during the infusion are expected and usually settle as the rate is adjusted.
  • Tell the nurse if you feel faint, dizzy or unwell during treatment.
  • Several daily infusions may be needed for a full course.

Evidence & guidelines

Controlled trials support intravenous iloprost for healing digital ulcers and reducing the frequency and severity of systemic-sclerosis-associated Raynaud's attacks.

Reference: EULAR SSc Treatment Recommendations 2016; Wigley FM et al. RCT (1994); NICE guidance (digital ulcers in SSc); SPC Ilomedin; 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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