Infasurf (calfactant) Offers Convenient Dosing

 

Instillation volume

  • Each dose of INFASURF is 3 mL/kg body weight of the 35 mg/mL suspension
  • The amount of a dose of INFASURF should be determined by body weight at birth

 

Retreatment is status driven

  • Allows dosing to be repeated only as needed
  • If needed after the initial dose, up to a total of 3 repeat doses of 3 mL/kg of birth weight can be given
    – 12 hours apart if the patient is still intubated, or
    – as early as 6 hours after the previous dose if the patient is still intubated and requires at least
    30% inspired oxygen to maintain a PaO2 ≤80 torr

 

INFASURF is ready to use

  • Does not require reconstitution
  • Warming is not required

 

Important considerations

  • Infasurf should be administered under the supervision of clinicians experienced in the acute care of newborn infants with respiratory failure who require intubation
  • Rapid and substantial increases in blood oxygenation and improved lung compliance often follow
    Infasurf instillation
  • Close clinical monitoring and surveillance following administration may be needed to adjust oxygen therapy and ventilator pressures appropriately

 

Dosing Chart

For Intratracheal Administration ONLY

Infasurf should be administered under the supervision of clinicians experienced in the acute care of newborn infants with respiratory failure who require intubation.

Calculating Dose

  • Each dose of INFASURF is 3 mL/kg body weight at birth
  • The INFASURF DOSING CHART shows the total dose per administration for a range of birth weights

Infasurf Dosing Chart

Doses were calculated using the midpoint of each weight range and rounded off to one decimal point (odd numbers rounded up, even numbers rounded level when last decimal is 5.)

Indication

Infasurf® (calfactant) is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS, and for the treatment of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.

Prophylaxis

Prophylaxis therapy at birth with Infasurf is indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.

Treatment

Infasurf therapy is indicated for infants ≤72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.

Important Safety Information

Infasurf is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING INFASURF, OFTEN RAPIDLY IMPROVES OXYGENATION AND LUNG COMPLIANCE. Following administration of Infasurf, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status.

Infasurf therapy is not a substitute for neonatal intensive care. Optimal care of premature infants at risk for RDS and new born infants with RDS who need endotracheal intubation requires an acute care unit organized, staffed, equipped, and experienced with intubation, ventilator management, and general care of these patients.

TRANSIENT EPISODES OF REFLUX OF INFASURF INTO THE ENDOTRACHEAL TUBE, CYANOSIS, BRADYCARDIA, OR AIRWAY OBSTRUCTION HAVE OCCURRED DURING THE DOSING PROCEDURES that required stopping Infasurf and taking appropriate measures to alleviate the condition. After the patient is stable, dosing can proceed with appropriate monitoring.

An increased proportion of patients with both intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) was observed in Infasurf-treated infants in the Infasurf-Exosurf Neonatal controlled trials. These observations were not associated with increased mortality.

The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death.

The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in the Table. Prophylaxis and treatment study results for each surfactant are combined.

Infasurf Safety Table

 

Infasurf Bottles

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