Helping babies breathe since 1998.
Infasurf® (calfactant) helps prevent and treat respiratory distress syndrome in newborns, restoring surface activity in the lungs and quickly improving respiration
- Rapid onset of action1
- Sustained respiratory improvement1,2
- Demonstrates single-dose success3,4,5
- Proven safe and effective1,2
- Ready to use. No mixing or warming required6
- Cost effective4
- Highest SP-B to phospholipid ratio6
- Biophysically potent7,8
- Only surfactant that retains surfactant cholesterol9
- Lowest dynamic and surface viscosity8,10
- Lung lavage vs. minced manufacturing process11
- No preservatives6
Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.
Prophylaxis therapy at birth with Infasurf is indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.
Infasurf therapy is indicated for infants ≤72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.
Infasurf is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING INFASURF, OFTEN RAPIDLY IMPROVES OXYGENATION AND LUNG COMPLIANCE. Following administration of Infasurf, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status.
Infasurf therapy is not a substitute for neonatal intensive care. Optimal care of premature infants at risk for RDS and newborn infants with RDS who need endotracheal intubation requires an acute care unit organized, staffed, equipped, and experienced with intubation, ventilator management, and general care of these patients.
TRANSIENT EPISODES OF REFLUX OF INFASURF INTO THE ENDOTRACHEAL TUBE, CYANOSIS, BRADYCARDIA, OR AIRWAY OBSTRUCTION HAVE OCCURRED DURING THE DOSING PROCEDURES that required stopping Infasurf and taking appropriate measures to alleviate the condition. After the patient is stable, dosing can proceed with appropriate monitoring.
An increased proportion of patients with both intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) was observed in Infasurf-treated infants in the Infasurf-Exosurf Neonatal controlled trials. These observations were not associated with increased mortality.
The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death.
The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in the Table. Prophylaxis and treatment study results for each surfactant are combined.
References: 1. Bloom BT, Kattwinkel J, Hall RT, et al. Comparison of Infasurf (calf lung surfactant extract) to Survanta (beractant) in the treatment and prevention of Respiratory Distress Syndrome. Pediatrics. 1997;100:31-38. 2. Attar M, Becker M, Dechert R, et al. Immediate changes in lung compliance following natural surfactant administration in premature infants with Respiratory Distress Syndrome: a controlled trial. J Perinatol. 2004;24:626-630. 3. Jeon GW, Oh M, Sin JB. Efficacy of surfactant-TA, calfactant and poractant alfa for preterm infants with Respiratory Distress Syndrome: A retrospective study. Yonsei Med J. 2015;56(2):433-439. 4. Zayek MM, Eyal FG, Smith RC. Comparison of the pharmacoeconomics of calfactant and poractant alfa in surfactant replacement therapy. JPPT. 2018;23(2):146-151. 5. Gerdes JS, Seiberlich W, Sivieri EM, et.al. An open label comparison of calfactant and poractant alfa administration traits and impact on neonatal intensive care unit resources. J Pediatr Pharmacol Ther. 2006;11(2):92-100. 6. Infasurf® (calfactant) Intratracheal Suspension Prescribing Information, ONY Biotech, March 2018. 7. Seeger W, Gruba C, Gunther A, et al. Surfactant inhibition by plasma proteins: differential sensitivity of various surfactant preparations. Eur Respir J. 1993;6:971-977. 8. Wang Z, Notter RH. Additivity of protein and nonprotein inhibitors of lung surfactant activity. Am J Respir Crit Care Med. 1998;158:28-35. 9. Kim K, Choi S, Zell Z, et al. Effect of cholesterol nanodomains on monolayer morphology and dynamics. Proc Natl Acad Sci USA. 2013;110:E3054-60. 10. Swartz D, Klein W, Row S, et al. Comparison of dynamic viscosities of lung surfactant drugs. Poster presented Hot Topics. 2017. 11. Notter RH. Lung Surfactants. Michael Dekker, New York, 2000, pp 171-232; 319-345.