NEODOSE

INDICATIONS

• Respiratory distress syndrome (RDS) in premature infants: It is strongly recommended that CPAP immediately after birth with subsequent selective surfactant administration be considered as an alternative to routine intubation with prophylactic or early surfactant administration in preterm infants. Severe RDS in preterm infants born younger than 30 weeks gestation who need mechanical ventilation should be administered surfactant after initial stabilization. Consider the use of rescue surfactant for infants with hypoxic respiratory failure attributable to secondary surfactant deficiency, such as meconium aspiration syndrome or sepsis/pneumonia.
• Comparative Trials: Animal-derived surfactants (beractant, calfactant, and poractant alfa) had comparable outcomes for air leak syndromes, death, and bronchopulmonary dysplasia in a retrospective study (n=51,282; median birth weight of 1435 g; median gestation age of 30 weeks (27 to 33 weeks))
• Late Administration: Poractant administered at 2 weeks of age in very preterm infants (less than 33 weeks’ gestation) on ventilation did not reduce the duration of ventilation; however, the rehospitalization rate for respiratory problems after discharge at 1 year of age was reduced (28.3% vs 51.1%; p=0.03) in a randomized, double-blinded, controlled, multicenter trial (n=118). The dosage of poractant was 2.5 mL/kg (200 mg/kg)

CONTRAINDICATIONS

Specific contraindications have not been.

PRECAUTIONS:

• Administration: Transient events (including bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation) may occur; stop administration and treat as needed, when patient is stable may continue dosing with appropriate monitoring
• Respiratory: Exogenous surfactants can rapidly affect oxygenation and lung compliance; monitoring required.

Pediatric FDA Approved Indications :

FDA APPROVED INDICATION

Indicated for the treatment (rescue) of respiratory distress syndrome in premature infants. Poractant alfa reduced mortality and pneumothoraces associated with RDS.

ADVERSE EFFECTS

Transient episodes of reflux of bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation have been reported during administration..

ADMINISTRATION

• For Endotracheal Tube Instillation Using a 5-French end-hole Catheter:
  • May suction the endotracheal tube before administration of surfactant.
  • Slowly withdraw the entire contents of the vial into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge); enter each single-use vial only once.
  • Attach the 5 French end-hole catheter of appropriate length to position the catheter tip proximal to the distal portion of the endotracheal tube, to the syringe. Fill the catheter with poractant alfa suspension. Discard excess poractant alfa through the catheter so that only the dose to be given remains in the syringe.
  • First aliquot: Keep infant in neutral position, right or left side dependent. Immediately before administration, ventilate the infant with supplemental oxygen to maintain SaO(2) greater than 92%. Insert catheter into the endotracheal tube and instill the first aliquot, then remove catheter and manually ventilate with supplemental oxygen until stable.
• For Endotracheal Tube Instillation Using the Second Lumen of a Dual Lumen Endotracheal Tube without Interrupting Ventilation:
  • May suction the endotracheal tube before administration of surfactant.
  • Slowly withdraw the entire contents of the poractant alfa suspension vial into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Do not attach 5 French end-hole catheter. Remove the needle and discard excess poractant alfa suspension so that only the dose to be given remains in the syringe.
  • Keep the infant in a neutral position (head and body in alignment without inclination). Administer poractant alfa suspension through the proximal end of the secondary lumen of the endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation.
  • After completion of this dosing procedure, ventilator management may require transient increases in FiO2 , ventilator rate, or PIP. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur

MONITORING

Monitor clinical and laboratory tests frequently for appropriate oxygen therapy and ventilatory support.