Poractant Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 22, 2024.

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 adverse events

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]

Further information

Poractant side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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