SURFACTANT UTILIZATION IN THE NICU

When evaluating surfactants, consider the impact of cumulative volume, need for redosing, and product wastage on the total cost of surfactant therapy.

With a low volume and high rates of single-dose success, CUROSURF may help minimize waste and reduce surfactant utilization in your NICU.1-11

Considerations in surfactant selection

The natural surfactants currently approved by the FDA have been studied in clinical trials, all of which evaluated many factors. Some of these factors may be relevant to your analysis when reviewing the surfactant class.

In preparing the analysis supporting a formulary decision, comparing a drug class against just 1 or 2 criteria may not capture all related concerns spanning the course of treatment.

The considerations presented here are a selection of factors that were considered in a number of trials, analyses and recommendations. To access the latest research studies, go to PubMed.gov, a portal maintained by the National Institutes of Health.

Surfactant considerations*
Surfactant administered in mg/kg per dose Incidence of adverse events
Redosing rate (patients requiring more than 1 dose) Duration of MV and days on oxygen
Onset of action (reduction of FiO2) Compatability with less invasive ventilation
Volume/viscosity Pharmacoeconomic assessments
Time needed for staff to administer Ability to faciliate desired protocol goals
Rate of complications during
administration (eg. ET tube blockage)
Administration/Storage
Rate of reflux Body of clinical evidence available

*This is not a comprehensive list, and some factors included in this list may not be relevant to all hospitals.

Consultation and collaboration with all stakeholders can help to identify and weigh how different considerations may impact patient treatment goals. Some individuals to consider consulting include:

  • NICU Medical Director
  • Staff Neonatologists
  • NICU Nurse Manager
  • Director of Respiratory Services (RRT)
  • NICU Clinical Pharmacist
  • Hospital Director of Pharmacy

CUROSURF delivers more surfactant with less volume1-5

SURFACTANT (mg/kg)INITIAL DOSE050100150200200100105Approximately2xmoresurfactantper initialdoseVOLUME (mL/kg)INITIAL VOLUME01234562.54.03.0LowestvolumeCUROSURF®(poractant alfa)Intratracheal SuspensionSurvanta®(beractant)Intratracheal SuspensionInfasurf®(calfactant)Intratracheal Suspension

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 of CUROSURF delivers a higher concentration of surfactant at a lower volume vs other exogenous surfactants1-6
  • Less volume may improve tolerability and has the potential to reduce complications such as airway obstruction12,13
  • 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 demonstrates consistently high rates of single-dose success6,9,14

0255075100CUROSURF®(poractant alfa)200 mg/kgSurvanta®(beractant)100 mg/kgMedian 28 wksn=126Dizdar EA, et al.201188%69%P=0.023≤32 wksn=92Karadag N, et al.201480%52%P=0.04Median 28.7 wksn=293Ramanathan R, et al.200473%51%P=0.002PATIENTS NOT REQUIRING A SUBSEQUENT DOSE (%)

Gestational age.

Across studies, infants treated with the 200 mg/kg initial dose of CUROSURF demonstrated higher rates of single-dose success vs those treated with Survanta.1,3,4,6

  • High rates of single-dose success limit the need to open additional vials for repeat dosing7-11
  • Limited need to redose may decrease the risks associated with reintubation and MV
  • Clinical studies have not established that fewer doses result in superior safety or efficacy based on clinically relevant end points

CUROSURF may help minimize wastage15

Infants’ administration experience with CUROSURF

CUROSURF demonstrated a 3.5% reflux rate 5 to 15 minutes after administration81% of babies recovered within 1 minute after administration

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


CUROSURF is a thin suspension that demonstrates a low reflux rate and fast recovery time after administration.1,15

  • In an open-label, observational study, the low rate of reflux may have been attributed to small volumes and low viscosity15
  • Low rates of reflux may help minimize drug loss, resource utilization, and the need to open multiple vials15
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Take a closer look at surfactants and RDS

We worked with Carla Christensen, PharmD, to develop this video presentation of some of the considerations that she recommends incorporating into a surfactant Medication Use Evaluation.

WATCH VIDEO
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. CUROSURF® (poractant alfa) Intratracheal Suspension Prescribing Information, Chiesi USA, Inc., December 2014. 2. Moya FR, Gadzinowski J, Bancalari E, et al. Pediatrics. 2005;115:1018-1029. 3. Sinha SK, Lacaze-Masmonteil T, Valls i Soler A, et al. Pediatrics. 2005;115:1030-1038. 4. Survanta® (beractant) Intratracheal Suspension Prescribing Information, AbbVie Inc, December 2012. 5. Infasurf® (calfactant) Intratracheal Suspension Prescribing Information, ONY, Inc, June 2011. 6. Dizdar EA, Sari FN, Aydemir C, et al. Am J Perinatol. 2012;29:95-100. 7. Sandri F, Plavka R, Ancora G, et al. Pediatrics. 2010;125:1402-1409. 8. Dani C, Bertini G, Pezzati M, Cecchi A, Caviglioli C, Rubaltelli FF. Pediatrics. 2004;113:e560-e563. 9. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K; and the North American Study Group. Am J Perinatol. 2004;21:109-119. 10. Verder H, Albertson P, Ebbesen F, et al. Pediatrics. 1999;103:1-6. 11. Speer CP, Gefeller O, Groneck P, et al. Arch Dis Child Fetal Neonatal. 1995;72:F8-F13. 12. Wiseman IR, Bryson HM. Drugs. 1994;48:386-403. 13. WAC Pricing. First Data Bank, Inc. Accessed 5/28/2014. 14. Karadag N, Dilli D, Zenciroglu A, Aydin B, Beken S, Okumus N. Am J Perinatol. 2014;31:1015-1022. 15. Gerdes JS, Seiberlich W, Sivieri EM, et al. J Pediatr Pharmacol Ther. 2006;11:92-100.