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INDICATION AND IMPORTANT SAFETY INFORMATION2
INDICATION2
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 |
| Intracranial hemorrhage | 48.1 | 45.2 | 0.241 |
| 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 |
| Necrotizing enterocolitis | 6.1 | 5.3 | 0.427 |
| Apnea | 65.4 | 59.6 | 0.283 |
| Severe apnea | 46.1 | 42.5 | 0.114 |
| Post-treatment sepsis | 20.7 | 16.1 | 0.019 |
| Post-treatment infection | 10.2 | 9.1 | 0.345 |
| Pulmonary hemorrhage | 7.2 | 5.3 | 0.166 |
aP-value comparing groups in controlled studies.
References: 1. US Food and Drug Administration. Drugs@FDA Approved Drug Products Database. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020032. Accessed February 5, 2020.
