General Information

Curosurf (poractant alfa) is a surfactant.

Curosurf is specifically indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants.

Curosurf is supplied as a suspension for ) intratracheal administration.

Before administering Curosurf , assure proper placement and patency of endotracheal tube.

 Administer intratracheally either in:

• Two divided aliquots through a 5 French end-hole catheter;
• A single bolus through secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation

Initial recommended dose is 2.5 mL/kg birth weight. Up to two repeat doses of 1.25 mL/kg birth weight may be administered at approximately 12-hour intervals. The maximum total dose (initial plus repeat doses) is 5 mL/kg

Mechanism of Action

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in Respiratory Distress Syndrome (RDS) characterized by poor lung expansion, inadequate gas exchange, and a gradual collapse of the lungs (atelectasis).

Curosurf compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.

Side Effects

Adverse effects associated with the use of Curosurf may include, but are not limited to, the following:

• bradycardia
• hypotension
• endotracheal tube blockage
• oxygen desaturation

Clinical Trial Results

The clinical efficacy of Curosurf F in the treatment of established Respiratory Distress Syndrome (RDS) in premature infants was demonstrated in one single-dose study (Study 1) and one multiple-dose study (Study 2) involving approximately 500 infants. Each study was randomized, multicenter, and controlled. In study 1, premature infants 700 to 2000 grams birth weight with RDS requiring mechanical ventilation and a FiO2 ≥ 0.60 were enrolled. Curosurf 2.5 mL/kg single dose (200 mg/kg) or control (disconnection from the ventilator and manual ventilation for 2 minutes) was administered after RDS developed and before 15 hours of age. 

• Mortality at 28 Days (All Causes) was 31% in the Curosurf arm versus 48% for the control arm
• Bonchopulmonary Dysplasia was 18% in the Curosurf arm versus  22% for the control arm
• Pneumothorax was 21% in the Curosurf arm versus 36% for the control arm
• Pulmonary Interstitial Emphysema was 21% in the Curosurf arm versus 38% for the control arm

In Study 2, premature infants 700 to 2000 g birth weight with RDS requiring mechanical ventilation and a FiO2 ≥ 0.60 were enrolled. In this twoarm trial, Curosurf was administered after RDS developed and before 15 hours of age, as a single-dose or as multiple doses. In the singledose arm, infants received Curosurf 2.5 mL/kg (200 mg/kg). In the multiple-dose arm, the initial dose of Curosurf was 2.5 mL/kg followed by up to two 1.25 mL/kg (100 mg/kg) doses of Curosurf . 

• Mortality at 28 Days (All Causes) was 21% in the single dose Curosurf arm versus 13% for the multiple dose arm
• Bonchopulmonary Dysplasia was 18% in the single dose Curosurf arm and 18% for the multiple dose arm
• Pneumothorax was 17% in the single dose Curosurf arm versus 9% for the multiple dose arm
• Pulmonary Interstitial Emphysema was 27% in the single dose Curosurf arm versus 22% for the multiple dose arm