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INDICATION AND IMPORTANT SAFETY INFORMATION2

INDICATION

SURVANTA 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.

Prevention: In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible, preferably within 15 minutes of birth.

Rescue: To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours of age.

IMPORTANT SAFETY INFORMATION

Warnings: SURVANTA is intended for intratracheal use only.

SURVANTA can rapidly affect oxygenation and lung compliance. 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. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=search.drugdetails. Accessed February 21, 2013. 2. SURVANTA [package insert].

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Instructional dosage and administration video for SURVANTA

Instructional dosage and administration video for SURVANTA

SAFETY CONSIDERATIONS2

  • SURVANTA is intended for intratracheal use only.
  • SURVANTA can rapidly affect oxygenation and lung compliance. 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.
  • In controlled clinical trials, an increased probability of post-treatment nosocomial sepsis was observed in SURVANTA-treated infants, which was not associated with increased mortality among these infants.

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