Poractant Alfa

What it is and how it works

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.

Mechanism class: Surfactant Activity

Indications

® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants.

Dosage and administration (summary)

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; or 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 Maximum total dose (initial plus repeat doses) is 5 mL/kg See Full Prescribing Information for instructions on preparation and administration of the CUROSURF suspension ( 2.3 , 2.4 ) Important Administration Instructions For intratracheal…

Contraindications

None. None.

Warnings and precautions

Acute Changes in Lung Compliance : Frequently assess need to modify oxygen and ventilatory support to respiratory changes Administration-Related Adverse Reactions : Transient adverse effects include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition Acute Changes in Oxygenation and Lung Compliance The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance.

Storage and supply

(poractant alfa) intratracheal suspension is a white to creamy white suspension available in sterile, rubber-stoppered clear glass vials containing (one vial per carton): 120 mg/1.5 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension: NDC Number: 10122-510-01 240 mg/3 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension.

Source: Poractant Alfa (Curosurf) — US FDA prescribing information, 2025-12-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.