CUROSURF^® (poractant alfa) Intratracheal Suspension

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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.^1,2 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 RDS³. Shortly after administration, the surfactant coats the alveoli to stabilize against collapse^4,5. By reducing surface tension, CUROSURF rapidly helps facilitate lung expansion and gas exchange in premature infants^4,5.

Each year, more infants are treated with CUROSURF than any other surfactant.⁶ Since launching in 1992, over 1 million infants have been treated worldwide.⁷ The safety and efficacy of CUROSURF have been established in 17 clinical trials, evaluating over 4,000 patients.⁷ CUROSURF is the surfactant most widely studied for use with less invasive ventilation techniques for the treatment of RDS in premature infants.^3,7

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.

You are encouraged to report negative side effects of prescrioption drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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For more information, please visit www.curosurf.com.

1. Hamilton BE, et al. Natl Vital Stat Rep 2010;58(16):14

2. NHLBI. http://www.nhlbi.nih.gov/health/dci/Diseases/rds/rds_whatis.html

3. CUROSURF^® (poractant alfa) Intratracheal Suspension prescribing information, Cornerstone Therapeutics Inc, April 2010.

4. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K; and The North American Study Group. Am J Perinatol. 2004;21:109-119.

5. Speer CP, Gefeller O, Groneck P, et al. Arch Dis Child. 1995;72:F8-F13.

6. IMS DDD Lung Surfactant Market Purchases May 2004 to December 2010.

7. Data on file, Chiesi Farmaceutici, S.p.A. and Cornerstone Therapeutics Inc.