INSURE Strategies

Conventional RDS Treatment Strategies (Respiratory Distress Syndrome)
Conventional Treatment Strategies
Pharmacy Considerations
Pharmacy Considerations
Leading the way to fast RDS (Respiratory Distress Syndrome) success
Leading the Way

A PROVEN FIT FOR TODAY’S LESS INVASIVE TREATMENT PROTOCOLS

It is important to consider composition, volume, effect on respiratory parameters, redosing requirements, and clinical evidence when evaluating a surfactant for use with INSURE.1-3 CUROSURF offers benefits that may help facilitate early rescue INSURE, including low volume, and the rapid onset of action and sustained results that may allow for minimal disruption of CPAP.4-8

Further research is needed to test the potential benefits of the INSURE strategy on important long-term outcomes.

Surfactant considerations for use with INSURE: Volume, Onset of Action, Redosing Requirements, & Duration

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

More surfactant, less volume*4,12-16

Dose/Volume Comparison of Exogenous surfactants

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

  • Initial dose delivers a higher concentration of surfactant at a lower volume vs other exogenous surfactants4,12-16
  • Less volume may improve tolerability and has the potential to reduce complications such as airway obstruction1,11
  • 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 quickly and evenly

CUROSURF distribution in lamb lungs over 4 minutes*9

CUROSURF is a thin intratracheal suspension. Chart shows distribution in lamb lungs over 4 minutes.

*Unpublished photos presented during the 15th International Workshop on Surfactant Replacement, 2000.

  • The above visual demonstrates surfactant distribution in lamb lungs over 4 minutes.9 Preclinical data may not be predictive of clinical results
  • In a subsequent clinical trial, CUROSURF quickly formed a stable surfactant monolayer inside alveoli10

CUROSURF demonstrates smooth administration

Infants’ administration experience2

1st DOSE VOLUME4 % 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.

  • Thin suspensions may help to minimize airway and endotracheal tube obstruction and associated complications such as transient hypercapnia1,2
  • In an open label trial, 81% of babies recovered within 1 minute following administration2

CUROSURF improves oxygenation within 5 minutes11,17

Oxygenation over 6 hours11

Comparison of oxygenation with CUROSURF and SURVANTA over 6 hours

Adapted from Speer CP et al. Arch Dis Child Fetal Neonatal Ed. 1995. Results from an open label study. No short term end points related to oxygenation were defined. a:APO2 = arterial to alveolar oxygen tension ratio.

  • Study patients received rescue surfactant and mechanical ventilation as primary intervention. Early rescue INSURE strategy not evaluated
  • Physiological end points (eg, faster reduction in FiO2) have not been proven to impact key clinical outcomes such as mortality due to RDS
  • 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

 

Reduction in respiratory requirements demonstrated over 72 hours12

Respiratory index over first 3 days of life12

Comparison of respiratory index with CUROSURF and SURVANTA over 72 hours

Adapted from Fujii AM, et al. J Perinatol. 2010. FiO2 = fraction of inspired oxygen. MAP = mean airway pressure.

  • Study patients received rescue surfactant and mechanical ventilation as primary intervention. Early rescue INSURE strategy not evaluated
  • In a clinical trial of ventilated infants, a 200 mg/kg initial dose of CUROSURF was associated with lower respiratory support requirements and the potential to extubate earlier than a 100 mg/kg dose of Survanta® (beractant)12
  • Physiological end points (eg, lower respiratory index) have not been proven to impact key clinical outcomes such as mortality due to RDS