iloprost trometamol: clinical use

Prescribing considerations

• Initiation and monitoring should be undertaken by clinicians experienced in the relevant vascular or pulmonary-hypertension condition.
• Review baseline blood pressure, bleeding risk, cardiovascular and cerebrovascular history, pregnancy status, hepatic function and severe renal impairment.
• Do not delay necessary surgery for limb-threatening infected gangrene while considering infusion therapy.
• Advise smoking cessation during infusion treatment for peripheral vascular disease.
• Avoid unintended aerosol exposure to others, particularly pregnant women, infants and newborns.

Contraindications and cautions

• Hypersensitivity and active conditions in which platelet inhibition would create an unacceptable haemorrhage risk.
• Severe coronary disease or unstable angina, recent myocardial infarction, severe arrhythmia and recent cerebrovascular events.
• Relevant valvular defects with myocardial dysfunction unrelated to pulmonary hypertension.
• Inhaled product: pulmonary hypertension due to pulmonary venous occlusive disease.
• Infusion product: pregnancy, lactation, pulmonary oedema and specified acute or chronic congestive heart failure.

Monitoring

• Blood pressure and heart rate during initiation and intravenous titration.
• Symptoms of hypotension, syncope, bleeding, bronchospasm, pulmonary oedema and cardiopulmonary deterioration.
• Infusion-line patency and local reactions; dilute the concentrate and administer it through dedicated controlled equipment.
• Closer monitoring where severe hepatic impairment or dialysis-dependent renal failure reduces iloprost clearance.

Clinical pharmacology

Iloprost is a short-acting synthetic prostacyclin analogue that activates vasodilatory and antiplatelet pathways. It is extensively metabolised, mainly by beta-oxidation, to inactive tetranor-iloprost; CYP-mediated metabolism is minor. Plasma concentrations fall rapidly after inhaled or intravenous administration.

Formulation and product differences

• The nebuliser solution is ready to use with specified compatible devices and acts preferentially on pulmonary vessels.
• The infusion concentrate must be diluted immediately before intravenous administration and used under strict clinical monitoring.
• Nebuliser devices are not interchangeable without supervision because aerosol delivery differs.
• The formulations have different licensed indications and pregnancy and breastfeeding restrictions.

Inhaled preparation

Route: Inhaled

Strengths: 10 micrograms/mL, 20 micrograms/mL

Solution for infusion

Route: Intravenous

Strengths: 20 micrograms, 100 micrograms, 100 micrograms/mL