Pharmacy Considerations

Conventional RDS Treatment Strategies (Respiratory Distress Syndrome)
Conventional Treatment Strategies
INSURE Strategies (Intubation Surfactant Rapid Extubation)
Insure Strategies
Leading the way to fast RDS (Respiratory Distress Syndrome) success
Leading the Way

Surfactant utilization

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® (poractant alfa) may help minimize waste and reduce surfactant utilization in your NICU.1-11

CUROSURF® (poractant alfa) delivers more surfactant with less volume

More surfactant, less volume*1-6

Initial and repeat doses of CUROSURF® (poractant alfa) are delivered at a lower volume vs other exogenous surfactants.1-6

CUROSURF delivers more than twice the phospholipid concentration (mg/mL) of other exogenous surfactants.1-6

Dose/Volume Comparison of Exogenous Surfactants

*Based on a 1000-g infant and manufacturer’s dosing schedule.

  • 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

Initial and repeat doses of CUROSURF® (poractant alfa) are delivered at a lower volume vs other exogenous surfactants.1-6

CUROSURF delivers more than twice the phospholipid concentration (mg/mL) of other exogenous surfactants.1-6

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 (http://www.pubmed.gov), a portal maintained by the National Institutes of Health.

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

Chart of key considerations in surfactant selection

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 demonstrates consistently high rates of single-dose success

Single-dose success in clinical studies7-11

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

CLINICAL STUDY N* GESTATIONAL AGE CUROSURF (200 mg/kg)
SINGLE-DOSE SUCCESS
Dizdar EA, et al. 20117 126 Median 28 wks 88%
Sandri F, et al. 2010 (treatment arm)8 103 Mean 27.0 ± 1.0 wks 78%
Dani C, et al. 20049 27 <30 wks 74%
Ramanathan R, et al. 200410 293 Mean 28.7 ± 2.0 wks 73%
Verder H, et al. 199911 60 25-29 wks 88%

*Total number of infants randomized.
Single-dose success is defined as no need for repeat doses of CUROSURF® (poractant alfa).

  • High rates of single-dose success limit the need to open additional vials for repeat dosing7-11
  • Clinical studies have not established that fewer doses result in superior efficacy or safety based on clinically relevant end points

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

CUROSURF may help minimize wastage

Infants’ administration experience14

CUROSURF is a thin suspension that demonstrates a low reflux rate and fast recovery time after administration.1,10

1st DOSE VOLUME1 % INITIAL DOSES ADMINISTERED IN
UNDER FIVE MIN
REFLUX RATE 5—15 MIN AFTER ADMINISTRATION RECOVERY TIME AFTER ADMINISTRATION
2.5 mL/kg 58.9% 3.5% 81% of babies
recovered within 1 minute

Adapted from Gerdes JS, et al. J Pediatr Pharmacol Ther. 2006.

  • In an open-label, observational study, the low rate of reflux may have been attributed to small volumes and low viscosity14
  • Low rates of reflux may help minimize drug loss, resource utilization, and the need to open multiple vials14

CUROSURF is a thin suspension that demonstrates a low reflux rate and fast recovery time after administration.1,10