- The total dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg) and is divided into 4 quarter-doses, also known
- Each of the 4 aliquots is given with the infant in a different position to help evenly distribute SURVANTA throughout the lungs.
For endotracheal administration using a 5 French end-hole catheter:
1. Slowly withdraw the entire contents of the vial into a plastic syringe through a large-gauge needle (e.g., at least 20 gauge).
2. Attach the premeasured 5 French end-hole catheter to the syringe. Fill the catheter with SURVANTA. Discard excess SURVANTA through the catheter so that only the total dose to be given remains in the syringe.
3. When administering SURVANTA using a 5 French end-hole catheter, administer in four quarter-dose aliquots. Each quarter dose is administered with the infant in a different position:
- Head and body inclined 5-10° down, head turned to the right
- Head and body inclined 5-10° down, head turned to the left
- Head and body inclined 5-10° up, head turned to the right
- Head and body inclined 5-10° up, head turned to the left
- Dosing is performed by one person administering the SURVANTA dose while another gently positions and monitors the infant.
4. First quarter-dose aliquot of SURVANTA suspension:
a. Position the infant appropriately in one of the four recommended positions.
b. Insert the 5 French end-hole catheter into the endotracheal tube. The tip of the catheter should protrude just beyond the end of the endotracheal tube above the infant’s carina. SURVANTA should not be instilled into a mainstem bronchus.
c. Gently inject the first quarter-dose aliquot through the catheter over 2–3 seconds.
d. After the first aliquot is instilled, remove the catheter from the endotracheal tube and manually ventilate the infant for at least 30 seconds or until clinically stable. Ventilate with sufficient oxygen to prevent cyanosis, and sufficient positive pressure to provide adequate air exchange and chest wall excursion.
5. When the infant is stable, reposition the infant for instillation of the next quarter-dose.
6. Instill each remaining quarter-dose using the same procedures.
7. After instillation of the final quarter-dose, remove the catheter without flushing it. Do not suction the infant for 1 hour after dosing unless signs of significant airway obstruction occur.
INDICATION AND IMPORTANT SAFETY INFORMATION1
SURVANTA® (beractant) is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.
IMPORTANT SAFETY INFORMATION
Warnings: SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.
During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.
Precautions: Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless clear-cut signs of airway obstruction are present. Increased probability of post-treatment nosocomial sepsis in SURVANTA-treated infants was observed in the controlled clinical trials. The increased risk for sepsis among SURVANTA-treated infants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate of post-treatment infections other than sepsis.
Use of SURVANTA in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials.
Adverse Reactions: The most commonly reported adverse experiences were transient bradycardia and oxygen desaturation; both were associated with the dosing procedure.
Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment.
The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in the table below.
|CONCURRENT EVENT||SURVANTA (%)||CONTROL (%)||P‑VALUEa|
|Patent ductus arteriosus||46.9||47.1||0.814|
|Severe intracranial hemorrhage||24.1||23.3||0.693|
|Pulmonary air leaks||10.9||24.7||<0.001|
|Pulmonary interstitial emphysema||20.2||38.4||<0.001|
aP-value comparing groups in controlled studies.