SURVANTA Frequently Asked Questions
Can more than one dose of SURVANTA be drawn out of a vial?
SURVANTA is supplied as a single-use vial, and does not contain antimicrobial preservatives. Therefore, the vial should not be entered more than once. Used vials with residual drug should be discarded.1
Color of SURVANTA
Is there anything wrong with the vials of drug we just received if the color is different from previously received drug?
The color of SURVANTA is off-white to light brown. There may be variations within this range from batch to batch. Each SURVANTA vial is visually inspected.1
Can a vial of SURVANTA still be used if it looks foamy when removed from the carton?
A small amount of foaming on the surface may occur during routine handling and is inherent to the product.1 Therefore, if the vial has not been shaken, it is acceptable to use the drug provided that the extent of foaming does not prohibit accurate dosing. A large amount of foaming may indicate that the vial has been shaken and the product should not be used.
Refrigeration of SURVANTA
How long can a vial of SURVANTA remain unrefrigerated before it should be discarded?
A vial may remain at room temperature continuously for a maximum of 24 hours. In order to ensure stability of the drug, vials left out of the refrigerator for longer than 24 hours should not be used and should be discarded. SURVANTA vials can be carried through one cycle of removal and exposure to room temperature for a maximum of 24 hours and subsequent return to the refrigerator. Once a vial is returned to room temperature a second time, it must be used within 24 hours or discarded.1
pH of SURVANTA
What is the pH range of SURVANTA?
The pH range of SURVANTA is 6.2 - 7.6.2
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.