SP-B

The Science

While our motivation is simple, the science that goes into creating a lung surfactant that resembles the real thing is a little more complicated.

Highest level of SP-B to phospholipid ratio makes Infasurf^® (calfactant) less affected by inhibitory proteins.

Plasma proteins can leak into alveolar space and inhibit surfactant function. Infasurf^® (calfactant) was the most resistant to the three surfactant-inhibiting proteins studied.¹

Comparison of SP-B in Exogenous Surfactants* SP-B Content as a % of Phospholipids

Native Lung Surfactant (calf)	Infasurf® (calfactant)	Curosurf® (poractant alfa)	Survanta® (beractant)
0.74%⁵	0.74%²	0.59%³	Unspecified⁴

Infasurf^® (calfactant) contains the highest levels of SP-B as a percentage of total phospholipids, same as native calf lung surfactant (0.74%)^1,2,5
Lab bench testing has shown surfactant films high in SP-B may be less susceptible to inhibitory proteins¹

Protein Inhibition Profile for Surfactants¹ Adsorption and Surface Tension Lowering

Surfactant vs. Inhibitory Protein (8 mg/mL concentration)
	Hemoglobin	Albumin	Fibrinogen
Infasurf® (calfactant)	Unaffected	Unaffected	Moderately Affected
Curosurf® (poractant alfa)	Severely Affected	Severely Affected	Severely Affected
Survanta® (beractant)	Severely Affected	Severely Affected	Severely Affected

Even when exposed to high levels of inhibitory proteins, Infasurf^® (calfactant) still rapidly adsorbs and lowers surface tension to near zero
Adsorption and surface tension lowering properties of the other surfactants are inhibited by plasma proteins at low concentrations

Efficacy Cost Benefits

* Chart does not imply clinical superiority of Infasurf^® (calfactant).
While clinical studies have demonstrated that SP-B is an essential element, they have not determined the minimum SP-B to phospholipid ratio required for optimal surfactant efficacy.
There are no prospective, randomized clinical trials comparing Infasurf^® and Curosurf^® with respect to safety or efficacy.

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. 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. 2. Infasurf^® (calfactant) Intratracheal Suspension Prescribing Information, ONY Biotech, March 2018. 3. Curosurf^® (poractant alfa) Intratracheal Suspension Prescribing Information, Chiesi USA, Inc. December 2014. 4. Survanta^® (beractant) Intratracheal Suspension Prescribing Information, AbbVie, Inc. December 2012. 5. Data on file, ONY Biotech.

SP-B

The Science

Highest level of SP-B to phospholipid ratio makes Infasurf® (calfactant) less affected by inhibitory proteins.

Comparison of SP-B in Exogenous Surfactants* SP-B Content as a % of Phospholipids

Protein Inhibition Profile for Surfactants1 Adsorption and Surface Tension Lowering

Highest level of SP-B to phospholipid ratio makes Infasurf^® (calfactant) less affected by inhibitory proteins.

Protein Inhibition Profile for Surfactants¹ Adsorption and Surface Tension Lowering