CUROSURF

What it is

CUROSURF is a suspension containing poractant alfa. It is a natural surfactant prepared from porcine lung consisting of 99% polar lipids (mainly phospholipids) and about 1% hydrophobic low molecular weight proteins (surfactant associated proteins SP-B and SP-C). Vials contain poractant alfa 120 mg in 1.5 mL or 240 mg in 3 mL. CUROSURF is a suspension for intratracheal administration.

Approved indications

— Treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants. — Prophylactic use in infants at risk of RDS.

Dosing overview

For rescue treatment, the initial recommended dose is 2.5 mL/kg birth weight (200 mg/kg). Up to two repeat doses of 1.25 mL/kg birth weight (100 mg/kg) each may be administered, at approximately 12 hour intervals, in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dose (sum of the initial and two repeat doses) is 5 mL/kg (400 mg/kg). For prophylaxis, a single dose of 100–200 mg/kg should be administered as soon as possible after birth (preferably within 15 minutes). Further doses of 100 mg/kg can be given 6–12 hours after the first dose and then 12 hours later in infants who have persistent signs of RDS and remain ventilator-dependent (maximum total dose: 300–400 mg/kg).

Key safety warnings

The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance; therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. The occurrence of intracranial haemorrhages after CUROSURF instillation has been related to reduction in mean arterial blood pressure and early peaks in arterial oxygenation (PaO2); avoidance of high PaO2 peaks by ventilator adjustment immediately after instillation is recommended. Infants treated with surfactant should be carefully monitored with respect to signs of infection; at the earliest signs of infection, the infant should immediately be given appropriate antibiotic therapy. Transient adverse effects seen with the administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage and oxygen desaturation.

Contraindications

CUROSURF is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients.

Regulatory history

CUROSURF received initial approval on 13 January 2005. Two strengths were registered on the ARTG: poractant alfa 120 mg/1.5 mL intratracheal suspension vial and poractant alfa 240 mg/3 mL intratracheal suspension vial, both first listed on 28 February 2005.