poractant alfa: clinical use

Prescribing considerations

• Restrict administration to clinicians experienced in the care, resuscitation and stabilisation of premature infants.
• Stabilise the infant's general condition and address acidosis, hypotension, anaemia, hypoglycaemia and hypothermia where possible.
• If response is inadequate or rapidly lost, assess for alternative or additional causes such as pneumonia, patent ductus arteriosus, airway obstruction or pulmonary hypoplasia.
• Administration to premature infants with severe hypotension has not been studied.

Contraindications and cautions

• Hypersensitivity to poractant alfa or an excipient; the SmPC identifies no other specific contraindication.

Monitoring

• Continuously monitor heart rate and oxygenation during administration.
• Expect potentially rapid improvement in compliance and gas exchange; adjust ventilatory support and inspired oxygen promptly to avoid hyperoxia.
• Pause administration and intervene if bradycardia, hypotension, oxygen desaturation, reflux or ventilation impairment occurs.
• Monitor for infection and complications of prematurity, including pneumothorax and pulmonary haemorrhage.

Clinical pharmacology

Poractant alfa is a porcine-lung phospholipid fraction containing hydrophobic surfactant proteins SP-B and SP-C. It spreads across the alveolar air–liquid interface, reduces surface tension and helps prevent end-expiratory alveolar collapse. After intratracheal administration it acts mainly within the lungs.

Formulation and product differences

• Ready-to-use, white-to-yellow sterile endotracheopulmonary suspension supplied in two single-use vial sizes.
• Both vial presentations contain the same formulation and require refrigerated, light-protected storage.
• The suspension contains sodium chloride, sodium hydrogen carbonate for pH adjustment and water for injections.