treprostinil sodium: clinical use

Prescribing considerations

• Initiate and monitor through clinicians experienced in pulmonary hypertension, with facilities for close medical supervision.
• Assess whether the patient or carer can safely manage a continuous infusion device and emergency procedures.
• Subcutaneous administration is preferred because chronic central venous access carries a serious bloodstream-infection risk.
• Avoid abrupt withdrawal; any interruption or reintroduction requires prompt, individualised clinical management.
• Use cautiously in hepatic or renal impairment, obesity, low systemic blood pressure and conditions that increase bleeding risk.
• Evidence is limited in children and several PAH-associated disease groups.

Contraindications and cautions

• Hypersensitivity to treprostinil or an excipient
• Pulmonary arterial hypertension related to pulmonary veno-occlusive disease
• Congestive heart failure caused by severe left-ventricular dysfunction
• Severe hepatic impairment
• Active gastrointestinal ulcer, intracranial haemorrhage, injury or another active bleeding condition
• Clinically important valvular disease with myocardial dysfunction unrelated to pulmonary hypertension
• Severe coronary disease or unstable angina, recent myocardial infarction, severe arrhythmia, recent cerebrovascular event, or inadequately supervised decompensated heart failure

Monitoring

• Symptoms, functional capacity and clinical response
• Systemic blood pressure and heart rate, particularly during treatment changes
• Bleeding and concomitant anticoagulant or antiplatelet therapy
• Subcutaneous infusion sites and intravenous catheter sites for infection
• Pump function, infusion continuity and patient competence with equipment
• Hepatic and renal function where clinically relevant
• New pulmonary oedema, which should prompt assessment for pulmonary veno-occlusive disease

Clinical pharmacology

Treprostinil is a prostacyclin analogue that directly dilates pulmonary and systemic arteries and inhibits platelet aggregation. Metabolism mainly involves CYP2C8, and hepatic impairment can substantially reduce clearance.

Formulation and product differences

• The selected product is a solution for continuous subcutaneous or intravenous infusion using an external pump.
• Subcutaneous administration uses undiluted solution and avoids central-catheter risks.
• Intravenous administration requires dilution with an authorised diluent and strict catheter-related infection precautions.

Solution for infusion

Route: Intravenous

Strengths: 1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL