CLINICAL PROFILE

Discover how CUROSURF provides fast RDS success and efficient administration. In addition to efficient administration, efficacy during the acute treatment phase is a critically important feature of a surfactant. Rapidly improved oxygenation, sustained efficacy, and fewer doses can all help wean infants to less invasive forms of ventilation.

Fast onset

CUROSURF improves oxygenation within 5 minutes and rapidly reduces FiO₂ requirements over the initial treatment period—delivering better short-term efficacy.^1,2

Physiological end points (eg, faster reduction in FiO₂) have not been proven to impact key clinical outcomes such as mortality due to RDS.

SEE THE DATASEE LESS

Faster reduction in FiO₂ requirements vs Survanta^® (beractant)*³

P<0.05 at all post-treatment time points.

*Primary endpoint was FiO₂ AUC_0-6 defining onset of clinical response.

FiO₂ = fraction of inspired oxygen.

Adapted from Ramanathan R, et al. Am J Perinatol. 2004;21:109-119.

CUROSURF improves oxygenation within 5 minutes^1,2

^†p<0.001.

^‡p<0.01.

^§p<0.5.

a:APO₂ = arterial to alveolar oxygen tension ratio.

Adapted from Speer CP, et al. Arch Dis Child Fetal Neonatal Ed. 1995;72:F8-F13. Results from an open-label study. No short-term end points related to oxygenation were defined.

It has been suggested that faster oxygenation supports the treatment goal of weaning infants from mechanical ventilation more rapidly³
Study patients received rescue surfactant and mechanical ventilation as primary intervention. Early rescue INSURE technique not evaluated
CUROSURF is intended for intratracheal use only. The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes
Physiological end points (eg, faster reduction in FiO₂) have not been proven to impact key clinical outcomes such as mortality due to RDS

Single-dose success

In clinical studies, most infants required only one dose of CUROSURF, which may reduce complications associated with reintubation and subsequent mechanical ventilation (MV).^3,4

Clinical studies have not established that fewer doses result in superior safety or efficacy based on clinically relevant end points.

SEE THE DATASEE LESS

Single-dose success demonstrated across multiple studies^3,5,6

^‖Gestational age.

Limited need to redose may decrease the risks associated with reintubation and MV³

Sustained results with fewer doses

CUROSURF demonstrates consistent FiO₂ reductions sustained over time.⁷

Differences in FiO₂ over 48 hours vs Survanta (beractant)^¶7

P=0.018 over first 48 hours.

^¶Shading indicates FiO₂ range in which redosing was required.

FiO₂ = fraction of inspired oxygen.

Adapted from Malloy CA, et al. Acta Paediatr. 2005;94:779-784. (N=58)

In a clinical trial, oxygen requirements did not rebound above redosing threshold (FiO₂ ≥0.30) after first dose of CUROSURF during the first 48 hours⁷
Sustained reduction of FiO₂ levels over 48 hours may reduce the need for redosing⁷

Reductions in respiratory index over the first 3 days of life vs Survanta⁸

P=0.032 over first 72 hours.

MAP = mean airway pressure.

Adapted from Fujii AM, et al. J Perinatol. 2010;30:665-670.

In a clinical trial, infants required lower respiratory support for the first 72 hours of life vs Survanta⁸
Lower respiratory requirements in the CUROSURF group could be attributed to a greater number of infants extubated at 48 and 72 hours vs Survanta⁸
Physiological end points (eg, faster reductions in FiO₂) have not been proven to impact key clinical outcomes such as mortality due to RDS

Lowest volume

CUROSURF delivers more surfactant with less volume, which may improve tolerability and has the potential to reduce complications such as airway obstruction.⁹

Clinical studies have not established that lower volume results in superior efficacy or safety based on clinically relevant end points.

SEE THE DATASEE LESS

CUROSURF delivers more surfactant with less volume^10-14

^#The initial recommended dose of CUROSURF is 2.5 mL/kg birth weight. Up to 2 repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12‑hour intervals. A total of 4 doses of Survanta (4 mL/kg birth weight) can be administered no more frequently than every 6 hours in the first 48 hours of life. Infasurf (3 mL/kg birth weight) can be administered every 12 hours, up to a total of 3 doses.

^**Based on a 1000-g infant and manufacturer’s dosing schedule. Volume of surfactant is measured in millimeters per kilogram of body weight at birth.

Initial dose delivers a higher concentration of surfactant at a lower volume vs other exogenous surfactants^10-14
Less volume may improve tolerability and has the potential to reduce complications such as airway obstruction^10-14
Clinical studies have not established that lower volume results in superior efficacy or safety based on clinically relevant end points
While clinical studies have demonstrated that phospholipids are an essential element, they have not established the quantity required for optimal surfactant efficacy

CUROSURF spreads fast and evenly for smooth instillation^††15

Control lamb: distribution in first 4 minutes

CUROSURF demonstrated a 3.5% reflux rate 5 to 15 minutes after administration

^††Unpublished photos presented during the 15th International Workshop on Surfactant Replacement, 2000.

Quickly forms a stable surfactant monolayer inside alveoli¹⁶
Suctioning of airways permitted after 1 hour¹⁰
Preclinical data may not be predictive of clinical results

CUROSURF is a thin suspension that demonstrates a low reflux rate and fast recovery time after administration⁹

3.5% reflux rate 5-15 min after administration (9).

81% of babies recovered within 1 min (9).

Adapted from Gerdes JS, et al. J Pediatr Pharmacol Ther. 2006;11:92-100.

In an open-label, observational study, CUROSURF demonstrated relatively quick administration and rapid recovery within 1 minute.⁹ In addition, CUROSURF demonstrated a low reflux rate, which may improve tolerability and ease of administration.⁹
It has been suggested that the thin suspension may help to minimize airway and endotracheal tube obstruction and associated complications such as transient hypercapnia^9,17

^‡‡It is important to note that the INSURE strategy may not be appropriate for all infants. Infants with RDS may vary markedly in the severity of respiratory disease, maturity, and presence of other complications, and thus it is necessary to individualize patient care.

IMPORTANT SAFETY INFORMATION

CUROSURF^® (poractant alfa) is intended for intratracheal use only. The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes.

CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.

Transient adverse reactions associated with 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.

Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, 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%).

INDICATION

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

Please see Full Prescribing Information.

References: 1. Speer CP, Gefeller O, Groneck P, et al. Arch Dis Child. 1995;72:F8-F13. 2. Collaborative European Multicenter Study Group. Pediatrics. 1988;82:683-691. 3. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K; And The North American Study Group. Am J Perinatol. 2004;21:109-119. 4. Verder H, Albertsen P, Ebbesen F, et al. Pediatrics. 1999;103:1-6. 5. Dizdar EA, Sari FN, Aydemir C, et al. Am J Perinatol. 2012;29:95-100. 6. Karadag N, Dilli D, Zenciroglu A, Aydin B, Beken S, Okumus N. Am J Perinatol. 2014;31:1015-1022. 7. Malloy CA, Nicoski P, Muraskas JK. Acta Pediatr. 2005;94:779-784. 8. Fujii AM, Patel SM, Allen R, et al. J Perinatol. 2010;30:665-670. 9. Gerdes JS, Seiberlich W, Sivieri EM, et al. J Pediatr Pharmacol Ther. 2006;11:92- 100. 10. CUROSURF^® (poractant alfa) Intratracheal Suspension Prescribing Information, Chiesi USA, Inc. May 2021. 11. Survanta^® (beractant) Intratracheal Suspension Prescribing Information, AbbVie, Inc. October 2020. 12. Infasurf^® (calfactant) Intratracheal Suspension Prescribing Information, ONY, Inc, March 2018. 13. Moya FR, Gadzinowski J, Bancalari E, et al. Pediatrics. 2005;115:1018-1029. 14. Sinha SK, Lacaze-Masmonteil T, Valls I, et al. Pediatrics. 2005;115:1030-1038. 15. Ingimarsson J, Björklund L, Jonson B, et al. Biol Neonate. 2000;77(suppl 1):24. 16. Schürch S, Schürch D, Curstedt T, Robertson B. J Appl Physiol.1994;77:974-986. 17. Wiseman IR, Bryson HM. Drugs. 1994;48:386-403.

CLINICAL PROFILE

Fast onset

Faster reduction in FiO2 requirements vs Survanta® (beractant)*3

CUROSURF improves oxygenation within 5 minutes1,2

Single-dose success

Single-dose success demonstrated across multiple studies3,5,6

Sustained results with fewer doses

Differences in FiO2 over 48 hours vs Survanta (beractant)¶7

Reductions in respiratory index over the first 3 days of life vs Survanta8

Lowest volume

CUROSURF delivers more surfactant with less volume10-14

CUROSURF spreads fast and evenly for smooth instillation††15

CUROSURF is a thin suspension that demonstrates a low reflux rate and fast recovery time after administration9

DEMONSTRATED SUCCESS WITH EARLY RESCUE INSURE‡‡

REVIEW DOSE PREPARATION AND HANDLING OF CUROSURF

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Faster reduction in FiO₂ requirements vs Survanta^® (beractant)*³

CUROSURF improves oxygenation within 5 minutes^1,2

Single-dose success demonstrated across multiple studies^3,5,6

Differences in FiO₂ over 48 hours vs Survanta (beractant)^¶7

Reductions in respiratory index over the first 3 days of life vs Survanta⁸

CUROSURF delivers more surfactant with less volume^10-14

CUROSURF spreads fast and evenly for smooth instillation^††15

CUROSURF is a thin suspension that demonstrates a low reflux rate and fast recovery time after administration⁹

DEMONSTRATED SUCCESS WITH EARLY RESCUE INSURE^‡‡