Efficacy

Infasurf® (calfactant) turns todays into tomorrows by rapidly adsorbing, lowering surface tension, and improving lung compliance overall.

Infasurf^® (calfactant) demonstrates surface tension lowering activity equal to that of native lung surfactant.¹

In Vitro Studies: Surface Tension Lowering

Redrawn from Wang Z, et al., 1998

Native Lung Surfactant 0.5 mg/mL

Infasurf® (calfactant) 0.75 mg/mL

Zero surface tension helps prevent alveoli collapse, increases the ability to achieve equal distribution of air throughout the lung and aids rapid respiratory recovery by increasing lung compliance^1,2

Infasurf (calfactant) is biophysically potent²

In Vitro Studies: Concentration Dependent Minimum Surface Tension

Redrawn from Seeger W, et al., 1993

Infasurf® (calfactant)

Curosurf® (poractant alfa)

Survanta® (beractant)

At a concentration of 1 mg/mL (circled area), Infasurf^® (calfactant) reaches zero surface tension
Higher concentrations are required by Curosurf^® (poractant alfa) to reach zero surface tension; Survanta^® (beractant) never reaches zero surface tension

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

With the first dose, Infasurf^® (calfactant) delivers a rapid, sustained response.

Potential for single-dose success and fewer doses.

Lowered FiO₂ significantly in the critical first 24 hours

Fraction of Inspired Oxygen (FiO₂)

Redrawn from Bloom BT, et al., 1997

Infasurf® (calfactant) n=303

Survanta® (beractant) n=305

*Significant difference (P<0.05) between groups at time indicated.

Potential for less oxygen requirement and less days on mechanical ventilation³
Infasurf^® (calfactant) demonstrates a long duration of action^3,4
Improvements in FiO₂ requirements may not necessarily reduce dosing or predict long-term outcomes
Preclinical and biologic testing do not predict clinical effects

The Science Cost Benefits Dosing & Instillation

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. Wang Z, Notter RH. Additivity of protein and nonprotein inhibitors of lung surfactant activity. Am J Respir Crit Care Med. 1998;158:28-35. 2. 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. 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;100:31-38. 4. 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.

Efficacy

Infasurf® (calfactant) demonstrates surface tension lowering activity equal to that of native lung surfactant.1

In Vitro Studies: Surface Tension Lowering

Infasurf (calfactant) is biophysically potent2