The INSURE strategy

Established benefits of surfactant, while avoiding prolonged MV1*

Early rescue INSURE strategy following nCPAP failure may help avoid the potential for respiratory insufficiency and the need for subsequent MV.1 In several studies, CUROSURF was administered via the early rescue INSURE strategy with a surfactant dosing threshold as low as 0.30.2†

*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.

†Dosing threshold ranged between 0.30 and 0.55.2-5

INSURE: INtubation, SURfactant, Rapid Extubation

INtibation
  • Initial intubation in NICU within 1 to 2 hours of birth6
SURfactant
  • When respiratory support with a ventilator is likely needed, early surfactant administration and rapid extubation is preferable over prolonged ventilation6
Rapid Extibation
  • Extubation should be performed when the infant is stable and at the discretion of the clinician
  • In some clinical studies, infants treated with CUROSURF using the INSURE strategy were generally extubated within approximately 5 to 10 minutes following surfactant administration2-5
  • Rapid extubation after surfactant administration may not be achievable or desirable in the most immature infants, and decisions to extubate should be individualized7

Less invasive respiratory distress syndrome treatment protocols

Today’s treatment protocols for RDS have shifted away from routine conventional intubation and subsequent MV.8

2014 American Academy of Pediatrics Recommendations6

AAP CPAP recommendation AAP less invasive ventilation 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.7,9-11

CUROSURF supports the goals of rapid extubation


Extubation within 5–10 minutes following surfactant administration 2-5
  • In some clinical studies, infants treated with CUROSURF using the INSURE strategy were generally extubated within approximately 5 to 10 minutes following surfactant administration2-5*
  • Extubation should be performed when the infant is stable at the discretion of the clinician

*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.

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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 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.2-5*‡


Graph showing percentage of single-dose success in 4 published studies

% Single-Dose Success

 

*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.

‡Single-dose success is defined as no need for repeat doses of CUROSURF. A single dose is not established to result in superior safety or efficacy.

A single dose is not established to result in superior safety or efficacy.

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 CUROSURF2-5*

CLINICAL STUDYGESTATIONAL AGEBIRTH WEIGHTSURFACTANT 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=0.37–0.5525%
Dani C, et al, 2004§29.0 ± 2.2 weeks1078 ± 321 gFiO2 ≥ 0.3015%
Bohlin K, et al, 2007‖ (retrospective)29.2 ± 1.8 weeks1333 ± 392 gFiO2 = 0.4519%
Leone F, et al, 2013§ (retrospective) 31 weeks (median) 30–33 weeks (range) 1660 g (median) 1180 g–2100 g (range)FiO2 = 0.458%
  • Across studies, administering CUROSURF via the early rescue INSURE strategy significantly reduced the need for subsequent MV vs alternate methods2-5*
  • In all 4 studies, infants were extubated within approximately 5-10 minutes following surfactant administration2-5
  • Rapid extubation after surfactant administration may not be achievable or desirable in the most immature infants, and decisions to extubate should be individualized7

*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.
§Need for MV before discharge.
‖Need for MV during the first week after surfactant treatment.

CUROSURF delivers fast onset, single-dose success,# and lowest volume#

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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. Stevens TP, Blennow M, Myers EH, et al. Cochrane Database Syst Rev. 2007; Issue 4. Art. No.:CD003063. 2. Dani C, Bertini G, Pezzati M, Cecchi A, Caviglioli C, Rubaltelli FF. Pediatrics. 2004;113:e560-e563. 3. Verder H, Albertsen P, Ebbesen F, et al. Pediatrics. 1999;103:E24. 4. Bohlin K, Gudmundsdottir T, Katz-Salamon M, Jonsson B, Blennow M. J Perinatol. 2007;27:422-427. 5. Leone F, Trevisanuto D, Cavallin F, Zanardo V. Minerva Pediatr. 2013;65:187-192. 6. Polin RA, Carlo WA; Committee on Fetus and Newborn; American Academy of Pediatrics. Pediatrics. 2014;133:156-163. 7. Committee on Fetus and Newborn; American Academy of Pediatrics. Pediatrics. 2014;133:171-174. 8. Pfister H, Soll RF. Clin Perinatol. 2012;39:459-481. 9. Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet J-M, Carlin JB; COIN Trial Investigators. N Engl J Med. 2008;358:700-708. 10. Dunn MS, Kaempf J, de Klerk A, et al; Vermont Oxford Network DRM Study Group. Pediatrics. 2011;128:e1069-e1076. 11. Sandri F, Plavka R, Ancora G, et al; CURPAP Study Group. Pediatrics. 2010;125:e1402-e1409.