NEODOSE

INDICATIONS

• Prevention and treatment of respiratory distress syndrome (RDS) in premature infants: Routine continuous positive airway pressure (CPAP) is considered superior to prophylactic surfactant therapy. 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. 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 gestational age of 30 weeks (27 to 33 weeks)).

FDA APPROVED INDICATION

• Prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS): Indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. Beractant significantly reduces the incidence of RDS, mortality due to RDS, and air leak complications

INDICATIONS

No specific contraindications have been determined.

PRECAUTIONS

• Administration:
  • For intratracheal use only.
• Cardiovascular:
  • Transient bradycardia and decreased oxygen saturation have been reported. Interrupt therapy and institute treatment as necessary.
• Immunologic:
  • Post-treatment nosocomial sepsis may occur.
• Respiratory:
  • Rapid effects on oxygenation and lung compliance occur with administration; intubation and ventilator management must be immediately available and frequent monitoring is required.
  • Rales and moist breath sounds have been reported after administration; endotracheal suctioning is not necessary unless airway obstruction present.

ADVERSE EFFECTS

Most common reactions reported include transient bradycardia (11.9% of doses) and oxygen desaturation (9.8% of doses). Other adverse events include hypotension, endotracheal tube reflux or blockage, hypertension, hypercarbia, hypocarbia, vasoconstriction, pallor, and apnea. In a pooled analysis of all controlled studies, the incidence of intracranial hemorrhage (ICH) was not different between the Survanta® group and the control group; however, in 2 of the studies (single-dose rescue study and multiple-dose prevention study), the incidence of ICH was significantly higher in patients who received Survanta® compared with those in the control group (63.3% vs 30.8%; p=0.001 and 48.8% vs 34.2%; p=0.047, respectively).

ADMINISTRATION

• Administration is facilitated if one person administers the dose while another person positions and monitors the infant.
• At discretion of the clinician, the endotracheal tube may be suctioned prior to administration of beractant; allow infant to stabilize before proceeding with dosing. Slowly withdraw the contents of the vial into a plastic syringe through a large gauge needle (eg, at least 20 gauge). Attach the premeasured 5 French end-hole catheter to the syringe and fill the catheter with beractant, discarding any excess product through the catheter so that only the total dose to be given remains in the syringe.
• Administer in 4 quarter-dose aliquots with the infant in a different position for each aliquot as follows: 1) head and body inclined 5 to 10 degrees down, head turned to right; 2) head and body inclined 5 to 10 degrees down, head turned to left; 3) head and body inclined 5 to 10 degrees up, head turned to right; 4) head and body inclined 5 to 10 degrees up, head turned to left.
• For each quarter-dose aliquot, insert the 5-French end-hole catheter into the endotracheal tube with the tip of the catheter protruding just beyond the end of the endotracheal tube above the infant’s carina; do not instill product into a mainstem bronchus. Gently inject the aliquot through the catheter over 2 to 3 seconds then remove the catheter and manually ventilate the infant for at least 30 seconds or until clinically stable. Use sufficient oxygen to prevent cyanosis and sufficient positive pressure to provide adequate air exchange and chest wall excursion.
• When the infant is stable following administration of an aliquot, reposition for instillation of the next quarter dose and then instill the dose using the same procedures.
• Once the final quarter-dose is administered, remove the catheter without flushing it. Do not suction the infant for 1 hour after dosing unless signs of significant airway obstruction occur.
• Each vial is for single-use only; discard unused product.

MONITORING

Monitor systemic oxygen and carbon dioxide levels with arterial or transcutaneous measurements frequently during therapy.