Applies to poractant: intratracheal suspension.

Side effects include:

Transient bradycardia, hypotension, endotracheal tube blockage, decreased oxygen saturation.

For Healthcare Professionals

Applies to poractant: intratracheal suspension.

General

Transient adverse effects include bradycardia, hypotension, endotracheal tube blockage and oxygen desaturation.^[Ref]

Cardiovascular

Very common (10% or more): Patent ductus arteriosus (up to 60%) in premature infants

Rare (less than 0.1%): Bradycardia, hypotension^[Ref]

Patent ductus arteriosus has also been reported with other exogenous surfactants and is attributed to hemodynamic changes induced by the rapid expansion of the lungs with surfactant administration.^[Ref]

Other

Very common (10% or more): Acquired pneumonia (up to 17%) and septicemia (14%) in premature infants

Uncommon (0.1% to 1%): Sepsis^[Ref]

Nervous system

Very common (10% or more): Intracranial hemorrhage (up to 51%) in premature infants

Uncommon (0.1% to 1%): Intracranial hemorrhage

Frequency not reported: Abnormal electroencephalogram^[Ref]

The occurrence of intracranial hemorrhages after instillation of this drug has been related to the reduction in mean arterial blood pressure and early peaks in arterial oxygenation (PaO2). High PaO2 peaks by ventilator adjustment immediately after instillation should be avoided.

Preterm newborns have relatively high incidences of cerebral hemorrhages and cerebral ischemia, reported as periventricular leukomalacia and hemodynamic anomalies such as patent ductus arteriosus and persistence of fetal circulation despite the provision of intensive care.

Seizures may also occur in the perinatal period.^[Ref]

Respiratory

Very common (10% or more): In premature infants: Pulmonary interstitial emphysema (up to 23%), pneumothorax (up to 21%), bronchopulmonary dysplasia (up to 18%)

Uncommon (0.1% to 1%): Pneumothorax

Rare (less than 0.1%): Bronchopulmonary dysplasia, decreased oxygen saturation

Frequency not reported: Hyperoxia, cyanosis neonatal, apnea, endotracheal intubation complication

Postmarketing reports: Pulmonary hemorrhage (known complication of premature birth and very low birth)^[Ref]

Apnea and sepsis may occur as consequences of the immaturity of the infants.

Preterm babies commonly develop hematological and electrolyte disorders which may be worsened by severe illness and mechanical ventilation. Other complications of prematurity, including the following disorders directly related to illness severity and use of mechanical ventilation necessary for reoxygenation, may also occur: Pneumothorax, interstitial pulmonary emphysema and pulmonary hemorrhage. The prolonged use of high concentrations of oxygen and mechanical ventilation are associated with the development of bronchopulmonary dysplasia and retinopathy of prematurity.^[Ref]