Survanta
Neofax 2017
Survanta (Beractant)
Dose
4 mL/kg/dose intratracheally, divided into 4 quarter-dose aliquots [1] (4 ml/kg/dosis = 100 mg/kg/dosis).
Prophylaxis: First dose is given as soon as possible after birth, preferably within 15 minutes of birth, with up to three additional doses in the first 48 hours of life, if indicated [1] ; give no more frequently than every 12 hours, unless surfactant is being inactivated by an infectious process, meconium, or blood [2] .
Rescue treatment of RDS: Up to four doses in first 48 hours of life, no more frequently than every 6 hours [1] ; typically administer no more frequently than every 12 hours, unless surfactant is being inactivated by an infectious process, meconium, or blood [2] . Administer as soon as possible, preferably within 2 hours after birth [2] .
Administration
Before administration, allow to stand at room temperature for 20 minutes, or warm in the hand for at least 8 minutes. Artificial warming methods should not be used [1] .
Shorten a 5F end-hole catheter so tip of catheter will protrude just beyond end of ET tube above infant's carina. Slowly withdraw entire contents of vial into a plastic syringe through a large (greater than 20 gauge) needle [1] .
Do not filter or shake. Attach shortened catheter to syringe. Fill catheter with Survanta. Discard excess Survanta through catheter so only total dose to be given remains in syringe [1] .
Administer four quarter-doses with the infant in different positions to enhance distribution. The catheter can be inserted into the infant's endotracheal tube through a neonatal suction valve without interrupting ventilation. Alternatively, Survanta can be instilled through the catheter by briefly disconnecting the endotracheal tube from the ventilator. After administration of each quarter-dose, the dosing catheter is removed from the ET tube and the infant is ventilated for at least 30 seconds until stable [1] .
Uses
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 [2] .
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)) [3] .
Neonatal FDA-Approved Indications: Indicated for prevention of respiratory distress syndrome (RDS) in premature infants less than 1250 g birth weight or with evidence of surfactant deficiency. Also indicated for treatment (rescue) of x-ray confirmed RDS in infants on mechanical ventilation. Beractant significantly reduces the incidence of RDS, mortality due to RDS, and air leak complications [1] .
Contraindications/Precautions
Transient episodes of bradycardia and decreased oxygen saturation may occur during administration.
Increased risk of post-treatment nosocomial sepsis was noted in SurvantaŽ-treated infants in controlled clinical studies [1] .
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 SurvantaŽ 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 SurvantaŽ 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) [1] .
Monitoring
Monitor systemic oxygen and carbon dioxide levels with arterial or transcutaneous measurements frequently during therapy [1] .
Pharmacology
SurvantaŽ is a modified natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins B and C, to which colfosceril palmitate (dipalmitoylphosphatidylcholine (DPPC)), palmitic acid, and tripalmitin are added.
Resulting drug provides 25 mg/mL phospholipids (including 11 to 15.5 mg/mL disaturated phosphatidylcholine), 0.5 to 1.75 mg/mL triglycerides, 1.4 to 3.5 mg/mL fatty acids, and less than 1 mg/mL protein.
SurvantaŽ is suspended in NS and heat sterilized. Animal metabolism studies show that most of a dose becomes lung-associated within hours of administration, and lipids enter endogenous surfactant pathways of reuse and recycling [1] .
Special Considerations/Preparation
Available in 4- and 8-mL single-use vials (25 mg phospholipids/mL).
Refrigerate at 2 to 8 degrees C (36 to 46 degrees F) and protect from light.
Inspect SurvantaŽ for discoloration; normal color is off-white to light-brown. If settling occurs during storage, swirl vial gently.
Do not shake.
Vials should be entered only once.
Used vials with residual drug should be discarded.
Unopened vials that have been warmed to room temperature one time may be refrigerated within 24 hours and stored for future use.
Should not be warmed and returned to the refrigerator more than once [1] .
References
Product Information: SURVANTA(R) intratracheal suspension, beractant intratracheal suspension. AbbVie Inc. (per manufacturer), North Chicago, IL, Dec, 2012.
Polin RA: Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics Jan, 2014; 133(1): 156-163.
Trembath A, Hornik CP, Clark R et al: Comparative effectiveness of surfactant preparations in premature infants. J Pediatr Oct, 2013; 163(4): 955-960.