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 RDS most commonly affects 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 or death.

CUROSURF^® (poractant alfa) Intratracheal Suspension 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 facilitates lung expansion and gas exchange in premature infants^4,5.

Each year, more infants are treated with CUROSURF than any other surfactant.⁶ Since first launched in Europe in 1992 and in the U.S. in 2000, over 1.5 million infants have been treated worldwide.⁷ The safety and efficacy of CUROSURF have been established in at least 19 clinical trials, evaluating over 4,700 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

Indication

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

Important Safety Information

CUROSURF (poractant alfa) 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 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 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.

Correction of acidosis, hypotension, anemia, hypoglycemia, and hypothermia is recommended prior to CUROSURF administration. Surfactant administration can be expected to reduce the severity of RDS but will not eliminate the mortality and morbidity associated with other complications of prematurity.

Pulmonary Hemorrhage is a known complication of premature birth and very low birth-weight and 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%).

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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-F136.
6. IMS NSP Lung Surfactant Market Report September 2012.
7. Data on file, Chiesi Farmaceutici, S.p.A. and Cornerstone Therapeutics Inc.

CUROSURF^® is a registered trademark of Chiesi Farmaceutici, S.p.A.