CLINICAL PROFILE

Discover how CUROSURF provides fast RDS success and efficient administration. In addition to efficient administration, efficacy during the acute treatment phase is a critically important feature of a surfactant. Rapidly improved oxygenation, sustained efficacy, and fewer doses can all help wean infants to less invasive forms of ventilation.

Fast onset

CUROSURF improves oxygenation within 5 minutes and rapidly reduces FiO2 requirements over the initial treatment period—delivering better short-term efficacy.1,2

Physiological end points (eg, faster reduction in FiO2) have not been proven to impact key clinical outcomes such as mortality due to RDS.

Single-dose success

In clinical studies, most infants required only one dose of CUROSURF, which may reduce complications associated with reintubation and subsequent mechanical ventilation (MV).3,4

Clinical studies have not established that fewer doses result in superior safety or efficacy based on clinically relevant end points.

Lowest volume

CUROSURF delivers more surfactant with less volume, which may improve tolerability and has the potential to reduce complications such as airway obstruction.9

Clinical studies have not established that lower volume results in superior efficacy or safety based on clinically relevant end points.

‡‡It is important to note that the INSURE strategy may not be appropriate for all infants. Infants with RDS may vary markedly in the severity of respiratory disease, maturity, and presence of other complications, and thus it is necessary to individualize patient care.

IMPORTANT SAFETY INFORMATION

CUROSURF® (poractant alfa) is intended for intratracheal use only. The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes.

CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.

Transient adverse reactions associated with administration of CUROSURF 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.

Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported with CUROSURF. The rates of common complications of prematurity observed in a multicenter single-dose study that enrolled infants 700–2000 g birth weight with RDS requiring mechanical ventilation and FiO2 ≥ 0.60 are as follows for CUROSURF 2.5 mL/kg (200 mg/kg) (n=78) and control (n=66; no surfactant) respectively: acquired pneumonia (17% vs. 21%), acquired septicemia (14% vs. 18%), bronchopulmonary dysplasia (18% vs. 22%), intracranial hemorrhage (51% vs. 64%), patent ductus arteriosus (60% vs. 48%), pneumothorax (21% vs. 36%) and pulmonary interstitial emphysema (21% vs. 38%).

INDICATION

CUROSURF® (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.

Please see Full Prescribing Information.

References: 1. Speer CP, Gefeller O, Groneck P, et al. Arch Dis Child. 1995;72:F8-F13. 2. Collaborative European Multicenter Study Group. Pediatrics. 1988;82:683-691. 3. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K; And The North American Study Group. Am J Perinatol. 2004;21:109-119. 4. Verder H, Albertsen P, Ebbesen F, et al. Pediatrics. 1999;103:1-6. 5. Dizdar EA, Sari FN, Aydemir C, et al. Am J Perinatol. 2012;29:95-100. 6. Karadag N, Dilli D, Zenciroglu A, Aydin B, Beken S, Okumus N. Am J Perinatol. 2014;31:1015-1022. 7. Malloy CA, Nicoski P, Muraskas JK. Acta Pediatr. 2005;94:779-784. 8. Fujii AM, Patel SM, Allen R, et al. J Perinatol. 2010;30:665-670. 9. Gerdes JS, Seiberlich W, Sivieri EM, et al. J Pediatr Pharmacol Ther. 2006;11:92- 100. 10. CUROSURF® (poractant alfa) Intratracheal Suspension Prescribing Information, Chiesi USA, Inc. December 2014. 11. Survanta® (beractant) Intratracheal Suspension Prescribing Information, AbbVie, Inc. December 2012. 12. Infasurf® (calfactant) Intratracheal Suspension Prescribing Information, ONY, Inc, June 2011. 13. Moya FR, Gadzinowski J, Bancalari E, et al. Pediatrics. 2005;115:1018-1029. 14. Sinha SK, Lacaze-Masmonteil T, Valls I, et al. Pediatrics. 2005;115:1030-1038. 15. Ingimarsson J, Björklund L, Jonson B, et al. Biol Neonate. 2000;77(suppl 1):24. 16. Schürch S, Schürch D, Curstedt T, Robertson B. J Appl Physiol.1994;77:974-986. 17. Wiseman IR, Bryson HM. Drugs. 1994;48:386-403.