SURVANTA was studied for prevention of RDS in two multiple-dose, randomized, multicenter, controlled studies of premature infants.*
Study Objective: To assess the incidence of death due to RDS in the neonatal period (28 days of age), death due to all causes, and death or bronchopulmonary dysplasia (BPD) due to RDS. Incidence of RDS, acute oxygen and ventilatory outcomes, concurrent complications of prematurity, and adverse experiences were also assessed.
*Study design: Infants of 600 to 1250 g birth weight and 23 to 29 weeks estimated gestational age were randomized at birth to receive either SURVANTA or sham air placebo in two multiple-dose studies. A dose of SURVANTA was given within
SURVANTA was studied for RDS rescue in two multiple-dose, randomized, multicenter, controlled studies in low birth weight infants.†
Study Objective: To assess the incidence of death due to RDS in the neonatal period (28 days of age) and the incidence of death or BPD due to RDS. Acute oxygen and ventilatory outcomes, concurrent complications of prematurity, and adverse experiences were also assessed.
†Study design: Infants of 600 to 1750 g birth weight with RDS requiring mechanical ventilation and an FiO2 ≥0.40 were randomized at birth to receive either SURVANTA or sham air placebo in two multiple-dose rescue studies. The initial dose of SURVANTA was given after RDS developed and before
a Sham air placebo. b Study discontinued when treatment IND was initiated. c Pneumothorax or pneumopericardium.
In the multiple-dose controlled clinical trials, transient bradycardia occurred with 11.9% of doses. Oxygen desaturation occurred with 9.8% of doses. 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.
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. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS, and air leak complications.
IMPORTANT SAFETY INFORMATION
Warnings: SURVANTA is intended for intratracheal use only.
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
Use of SURVANTA in infants less than 600 g birth weight or greater than
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
|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.