Single-Dose Success

Dosing & Instillation

Infasurf® (calfactant) is ready to use, no mixing or warming required.

Infasurf^® (calfactant) can result in fewer doses and high rates of single-dose success.

Low Re-Dose Rates*

Infasurf® (calfactant) n=762

Curosurf® (poractant alfa) n=432

Infasurf® (calfactant) n=96

Curosurf® (poractant alfa) n=90

Number of Doses per Patient*

Infasurf® (calfactant) n=762

Curosurf® (poractant alfa) n=432

Infasurf® (calfactant) n=64

Curosurf® (poractant alfa) n=213

*Infasurf® (calfactant) All Doses 105 mg/kg, Curosurf® (poractant alfa) Initial Dose 200 mg/kg, Repeat Doses 100 mg/kg

Repeat dosing rates varied depending on patient demographics, surfactant utilized, hospital protocols and established practices¹
Clinical studies have not determined superior safety or efficacy with fewer doses

There are no prospective, randomized clinical trials comparing Infasurf^® and Curosurf^® with respect to safety or efficacy.

Cost Benefits FAQ’s

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

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.

Treatment

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.

See full prescribing information.

References: 1. 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. 2. 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 3. 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.

1. Attar M, Becker M, Dechert RE, Donn SM. Immediate changes in lung compliance following natural surfactant administration in premature infants with respiratory distress syndrome: a controlled trial. J Perinatol. 2004; 24(10):626-630. 2. Bloom BT, Clark RH. Comparison of Infasurf (calfactant) and Survanta (beractant) in the prevention and treatment of respiratory distress syndrome. Pediatrics. 2005; 116(2):392-399. 3. 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(1):31-38. doi:10.1542/peds.100.1.31. 4. Borszewska-Kornacka MK, Kostuch M, Korbal P, Krajewski P. Strategies of Using Surfactant: Results of the First Polish National Survey of Daily Practice. Dev period Med. 2015; 19(3 Pt 1):271-276. 5. Dani C, DoRavasio R, Fioravanti L, Circelli M. Analysis of the cost-effectiveness of surfactant treatment (Curosurf®) in respiratory distress syndrome therapy in preterm infants: early treatment compared to late treatment. Ital J Pediatr. 2014; 40(1):40. 6. Dilmen U, Ozdemir R, Tatar Aksoy H, et al. Early regular versus late selective poractant treatment in preterm infants born between 25 and 30 gestational weeks: a prospective randomized multicenter study. J Matern Fetal Neonatal Med. 2014; 27(4):411-415. 7. Dizdar EA, Sari FN, Aydemir C, et al. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. Am J Perinatol. 2012; 29(2):95-100. 8. Fujii AM, Patel SM, Allen R, Doros G, Guo C-Y, Testa S. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. J Perinatol. 2010; 30(10):665-670. 9. 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. 10. Gharehbaghi MM, Yasrebi S. Comparing the Efficacy of two Natural Surfactants, Curosurf and Alveofact, in Treatment of Respiratory Distress Syndrome in Preterm Infants. Int J Women’s Heal Reprod Sci. 2014; 2(4):245-248. 11. Gharehbaghi MM, Sakha SHP, Ghojazadeh M, Firoozi F. Complications among premature neonates treated with beractant and poractant alfa. Indian J Pediatr. 2010; 77(7):751-754. 12. Halliday HL, Tarnow-Mordi WO, Corcoran JD, Patterson CC. Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curosurf 4 trial). Arch of Dis Child 1993;69:276-280. 13. Hastings LK, Renfro WH, Sharma R. Comparison of beractant and calfactant in a neonatal intensive care unit. Am J Health Syst Pharm. 2004; 61(3):257-260. 14. Hudak ML, Martin DJ, Egan E a., et al. A Multicenter Randomized Masked Comparison Trial of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome. Pediatrics. 1997;100(1):39-50. doi:10.1542/peds.100.1.39. 15. Hudak ML, Farrell EE, Rosenberg AA, et al. A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome. J Pediatr. 1996;128(3):396-406. 16. 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. 17. Karadag N, Dilli D, Zenciroglu A, Aydin B, Beken S, Okumus N. Perfusion index variability in preterm infants treated with two different natural surfactants for respiratory distress syndrome. Am J Perinatol. 2014; 31(11):1015-1022.
18. Kuint J1, Reichman B, Neumann L, Shinwell ES. Prognostic value of the immediate response to surfactant. Arch Dis Child Fetal Neonatal Ed. 1994 Nov;71(3):F170-3. 19. Lamboley-Gilmert G, Lacaze-Masmonteil T. The short-term outcome of a large cohort of very preterm infants treated with poractant alfa (Curosurf®) for respiratory distress syndrome: A postmarketing phase IV study. Pediatr Drugs. 2003; 5(9):639-645. 20. Lemyre B, Fusch C, Schmöl zer GM et al. Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial. PLoS ONE 2017; 12(5): e0175922. 21. Leone F, Trevisanuto D, Cavallin F, Parotto M, Zanardo V. Efficacy of INSURE during nasal CPAP in preterm infants with respiratory distress syndrome. Minerva Pediatr. 2013; 65(2):187-192. 22. Malloy CA, Nicoski P, Muraskas JK. A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome. Acta Paediatr. 2005; 94(6):779-784. 23. Najafian B, Karimi-Sari H, Khosravi MH, Nikjoo N, Amin S, Shohrati M. Comparison of efficacy and safety of two available natural surfactants in Iran, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome: A randomized clinical trial. Contemp Clin Trials Commun. 2016; 3:55-59. 24. Naseh A, Yekta BG. INSURE method (INtubation-SURfactant-Extubation) in early and late premature neonates with respiratory distress: factors affecting the outcome and survival rate. Turk J Pediatr. 2014; 56(3):232-237. 25. Paul S, Rao S, Kohan R, et al. Poractant alfa versus beractant for respiratory distress syndrome in preterm infants: a retrospective cohort study. J Paediatr Child Health 2013;49:839–844. 26. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K. A Randomized, Multicenter Masked Comparison Trial of Poractant Alfa (Curosurf) versus Beractant (Survanta) in the Treatment of Respiratory Distress Syndrome in Preterm Infants. Am J Perinatol. 2004; 21(3):109-119. 27. Ricotti A, Salvo V, Zimmermann LJI, et al. N-SIPPV versus bi-level N-CPAP for early treatment of respiratory distress syndrome in preterm infants. J Matern Fetal Neonatal Med. 2013; 26(13):1346-1351. 28. Sandri F, Plavka R, Ancora G, et al. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics. 2010; 125(6):e1402-9. 29. Speer CP, Gefeller O, Groneck P, et al. Randomised clinical trial of two treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome Arch Dis Child Fetal Neonatal Ed. 1995 Jan;72(1):F8-13. 30. Speer CP, Robertson B, Curstedt T, et al. Randomized European multicenter trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf Pediatrics. 1992 Jan;89(1):13-20. 31. Tsakalidis C, Giougki E, Karagianni P, Dokos C, Rallis D, Nikolaidis N. Is there a necessity for multiple doses of surfactant for respiratory distress syndrome of premature infants? Turk J Pediatr. 2012; 54(4):368-375. 32. Van Kaam AH, De Jaegere AP, Borensztajn D, Rimensberger PC. Surfactant replacement therapy in preterm infants: A European survey. Neonatology. 2011; 100(1):71-77. 33. Walti H, Paris-Llado J, Bréart G, Couchard M . Porcine surfactant replacement therapy in newborns of 25-31 weeks’ gestation: a randomized, multicentre trial of prophylaxis versus rescue with multiple low doses. The French Collaborative Multicentre Study GroupActa Paediatr. 1995 Aug;84(8):913-21. 34. 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.

Single-Dose Success

Dosing & Instillation

Infasurf® (calfactant) can result in fewer doses and high rates of single-dose success.

Low Re-Dose Rates*

Number of Doses per Patient*

Infasurf^® (calfactant) can result in fewer doses and high rates of single-dose success.