A PROVEN FIT FOR TODAY’S LESS INVASIVE RDS TREATMENT PROTOCOLS

Today’s treatment protocols for respiratory distress syndrome (RDS) have shifted away from routine conventional intubation and subsequent mechanical ventilation (MV).1

2014 American Academy of Pediatrics Recommendations2

CPAP immediately after birth with subsequent selective surfactant administration may be considered as an alternative to routine intubationCPAPStrong Recommendation
Less invasive ventilationIf respiratory support with a ventilator is likely needed, early administration of surfactant followed by rapid extubation is preferable to prolonged ventilationStrong Recommendation

While initial stabilization on nCPAP has proven to be a viable option for spontaneously breathing infants at risk for RDS, studies suggest approximately 50% of infants may require subsequent intubation and selective surfactant administration.2-7

Intubation, SURfactant, Rapid Extubation

The INSURE strategy: established benefits of surfactant, while avoiding prolonged MV*8

  • Extubation should be performed when the infant is stable at the discretion of the clinician
  • Early rescue INSURE strategy following nCPAP failure may help avoid potential for respiratory insufficiency and the need for subsequent MV8
  • In studies, early rescue INSURE strategy (FiO2 ≤0.45) was associated with improved outcomes vs late selective therapy
    (FiO2 >0.45)8
  • Rapid extubation after surfactant administration may not be achievable or desirable in the most immature infants, and decisions to extubate should be individualized
  • In some clinical studies, infants treated with CUROSURF using the INSURE strategy were generally extubated within approximately 5 to 10 minutes following surfactant administration9-12
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Take a closer look at the INSURE strategy

Watch an overview about the research behind the INSURE strategy and a step-by-step guide of how to administer CUROSURF.

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CUROSURF supports the goals of rapid extubation

Extubation within5–10 minutesfollowing surfactantadministration9-12
  • In some clinical studies, infants treated with CUROSURF using the INSURE strategy were generally extubated within approximately 5 to 10 minutes following surfactant administration*9-12
  • Extubation should be performed when the infant is stable at the discretion of the clinician

CUROSURF delivers consistently high rates of single-dose success

In several studies, administering CUROSURF via the early rescue INSURE strategy resulted in both consistently high rates of single-dose success and significant reduction in the need for subsequent MV vs alternate methods.*†9-12

Verder H, et al. 1999Dani C, et al. 2004Bohlin, et al. 2004(retrospective)Leone, et al. 2013(retrospective)91%100%83%84%65707580859095100

% SINGLE-DOSE SUCCESS


Single-dose success is defined as no need for repeat doses of CUROSURF.

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.

Low MV rates following early rescue INSURE with CUROSURF*9-12

CLINICAL STUDY GESTATIONAL AGE BIRTH WEIGHT SURFACTANT DOSING THRESHOLD % REQUIRING MV FOLLOWING EARLY RESCUE INSURE WITH CUROSURF
Verder H, et al. 1999 27 weeks (median) 25–29 weeks (range) 950 g (median) 665–1600 g (range) FiO2=0.37–0.55 25%
Dani C, et al. 2004 29.0 ± 2.2 weeks 1078 ± 321 g FiO2 ≥ 0.30 15%
Bohlin K, et al. 2007§ (retrospective) 29.2 ± 1.8 weeks 1333 ± 392 g FiO2 = 0.45 19%
Leone F, et al. 2013 (retrospective) 31 weeks (median) 30–33 weeks (range) 1660 g (median) 1180 g–2100 g (range) FiO2 = 0.45 8%

Need for MV before discharge.

§Need for MV during the first week after surfactant treatment.

  • Across studies, administering CUROSURF via the early rescue INSURE strategy significantly reduced the need for subsequent MV vs alternate methods*9-12
  • In all 4 studies, infants were extubated within approximately 5-10 minutes following surfactant administration9-12
  • Rapid extubation after surfactant administration may not be achievable or desirable in the most immature infants, and decisions to extubate should be individualized

*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.

Not proven to impact clinical outcomes such as mortality.

Not established to result in superior safety or efficacy.

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. Pfister RH, Soll RF. Clin Perinatol. 2012;39:459-481. 2. Committee on Fetus and Newborn. Pediatrics. 2014;133:171-174. 3. Polin RA, Carlo WA, Committee on Fetus and Newborn. Pediatrics. 2014;133:156-163. 4. Morley CJ, Davis PG, Doyle LW, et al. N Engl J Med. 2008;358:700-708. 5. SUPPORT Study Group. N Engl J Med. 2010;362:1970-1979. 6. Dunn MS, Kaempf J, de Klerk A, et al. Pediatrics. 2011;128:e1069-e1076. 7. Sandri F, Plavka R, Ancora G, et al. Pediatrics. 2010;125:1402-1409. 8. Stevens TP, Blennow M, Myers EH, et al. Cochrane Database of Systematic Reviews. 2007; Issue 4. Art. No.:CD003063. 9. Dani C, Bertini G, Pezzati M, et al. Pediatrics. 2004;113:e560-e563. 10. Verder H, Albertsen P, Ebbesen F, et al. Pediatrics. 1999;103:1-6. 11. Bohlin K, Gudmundsdottir T, Katz-Salamon M, et al. J Perinatol. 2007;27:422-427. 12. Leone F, Trevisanuto D, Cavallin F, et al. Minerva Pediatr. 2013;65:187-192.