Available in 4 and
8 mL vials
Vials not actual size.
Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight
Use of SURVANTA in infants less than 600 grams birth weight or greater than 1750 grams birth weight has not been evaluated in controlled trials.
For intratracheal administration only.
SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.
Marked improvements in oxygenation may occur within minutes of administration of SURVANTA. Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.
Review of audiovisual instructional materials describing dosage and administration procedures is recommended before using SURVANTA.
SURVANTA Dosing Chart for Prevention and Treatment of RDS1
|Weight (grams)||Total Dose (mL)|
Four total doses of SURVANTA can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.
Directions for Use
SURVANTA should be inspected visually for discoloration prior to administration. The color of SURVANTA is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Some foaming at the surface may occur during handling and is inherent in the nature of the product.
SURVANTA is stored refrigerated (2-8° C). Date and time need to be recorded in the box on front of the carton or vial whenever SURVANTA is removed from the refrigerator. Before administration, SURVANTA should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. Artificial warming methods should not be used. If a prevention dose is to be given, preparation of SURVANTA should begin before the infant’s birth.
Unopened, unused vials of SURVANTA that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming and stored for future use. SURVANTA SHOULD NOT BE REMOVED FROM THE REFRIGERATOR FOR MORE THAN 24 HOURS. SURVANTA SHOULD NOT BE WARMED AND RETURNED TO THE REFRIGERATOR MORE THAN ONCE. Each single-use vial of SURVANTA should be entered only once. Used vials with residual drug should be discarded.
SURVANTA does not require reconstitution or sonication before use.
- 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.
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.
Prevention: In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible, preferably within
Rescue: To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours
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
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.