CUROSURF® (poractant alfa) Intratracheal Suspension
Each year in the U.S., approximately 50,000 premature infants are born at risk for neonatal Respiratory Distress Syndrome (RDS), also known as Hyaline Membrane Disease. It is most commonly suffered by premature babies born before 32 weeks of gestation.
RDS is caused by a deficiency in alveolar surfactant, a natural fluid coating that helps reduce surface tension in the lungs. Without adequate surfactant the alveoli will collapse and the baby will have serious difficulties breathing. If left untreated, RDS may contribute to serious acute complications, long-term consequences and death.
CUROSURF is a naturally derived surfactant indicated for the treatment (rescue) of RDS in premature infants. The product has been shown to reduce mortality and pneumothoraces associated with RDS. Shortly after administration, the surfactant rapidly coats the alveoli to stabilize against collapse. By reducing surface tension, CUROSURF helps facilitate lung expansion and gas exchange in premature infants.
Since launching in 1992, CUROSURF has become the global market leader for surfactants. In 2000, the product was approved for the U.S. market, and has steadily grown into a prominent surfactant option for the treatment of RDS. CUROSURF has been studied with common ventilation strategies2,3.
Important Safety Information
CUROSURF® Intratracheal Suspension is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING CUROSURF® INTRATRACHEAL SUSPENSION, CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, infants receiving CUROSURF® Intratracheal Suspension should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified in response to respiratory changes.
CUROSURF® Intratracheal Suspension should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.
TRANSIENT ADVERSE EFFECTS SEEN WITH THE ADMINISTRATION OF CUROSURF® INTRATRACHEAL SUSPENSION INCLUDE BRADYCARDIA, HYPOTENSION, ENDOTRACHEAL TUBE BLOCKAGE, AND OXYGEN DESATURATION. These events require stopping CUROSURF® administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.
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1. Dani C, Bertini G, Pezzati M, Cecchi A, Caviglioli C, Rubaltelli FF. Early extubation and nasal continuous positive airway pressure after surfactant treatment for respiratory distress syndrome among preterm infants <30 weeks' gestation. Pediatrics. 2004;113:e560-e563.
2. Verder H, Albertsen P, Ebbesen F, et al. Nasal continuous positive airway pressure and early surfactant therapy for respiratory distress syndrome in newborns of less than 30 weeks' gestation. Pediatrics. 1999;103:E24.