(For additional information see "Beractant: Pediatric drug information")
Dosage guidance:
Dosage form information: 1 mL of beractant contains 25 mg of phospholipids.
Respiratory distress syndrome (RDS): Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using continuous positive airway pressure (CPAP) immediately after birth with subsequent selective surfactant administration (Ref); routine prophylactic surfactant administration is no longer recommended (Ref).
Rescue treatment:
Endotracheal administration: Note: Use for INSURE technique (INtubation-SURfactant-Extubation) or patients requiring invasive respiratory support (eg, mechanical ventilation):
Preterm neonates: Endotracheal: 4 mL/kg following a diagnosis of significant RDS; additional doses may be administered if patient remains intubated and requires at least 30% inspired fraction of oxygen (FiO2) to maintain adequate oxygenation; dosing more often than every 12 hours is typically not required unless surfactant is being inactivated by an infectious process, meconium, or blood; doses should not be given more frequently than every 6 hours; up to 4 doses may be administered if evidence of respiratory distress continues (Ref).
Prophylactic therapy: Note: Routine prophylactic surfactant administration is no longer recommended (Ref).
Preterm neonates: Endotracheal: 4 mL/kg as soon as possible after birth, preferably within 15 minutes.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. The following occurred during the dosing procedure:
>10%: Cardiovascular: Bradycardia (transient)
1% to 10%: Respiratory: Oxygen desaturation
<1%, postmarketing, and/or case reports: Apnea, emphysema (pulmonary interstitial), hypercapnia, hypertension, hypotension, increased susceptibility to infection (post-treatment nosocomial sepsis), low blood CO2, obstruction of endotracheal tube, pallor, pneumothorax (including pneumopericardium), vasoconstriction
There are no contraindications listed in the manufacturer's labeling
Concerns related to adverse effects:
• Mucous plugs: Marked impairment of ventilation during or shortly after dosing may indicate mucous plugging of the endotracheal tube; suctioning all neonates prior to administration may decrease chance of endotracheal tube obstruction. Replace endotracheal tube immediately if obstruction is not removed with suctioning.
• Nosocomial sepsis: There is an increased risk of post-treatment nosocomial sepsis in treated neonates this increased risk was not associated with increased mortality.
• Transient adverse effects: Transient episodes of bradycardia and decreased oxygen saturation may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable. Rales and moist breath sounds may occur; endotracheal suctioning or other remedial action is necessary if clear-cut signs of airway obstruction are present.
Other warnings/precautions:
• Administration: Intended for endotracheal administration only.
• Appropriate use: Use in neonates <600 grams birth weight or >1,750 grams birth weight has not been evaluated.
• Lung oxygenation/lung compliance: Produces rapid improvements in lung oxygenation and compliance that may require frequent adjustments to oxygen delivery and ventilator settings; hyperoxia may occur within minutes of administration.
• Trained personnel: Rapidly affects oxygenation and lung compliance; restrict use to a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature neonates.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intratracheal:
Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)
No
Suspension (Survanta Intratracheal)
25 mg/mL 0.9% (per mL): $114.90
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intratracheal:
Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)
Specific administration method may vary with ventilation technique.
Endotracheal/Intratracheal: Allow beractant to stand at room temperature for 20 minutes or warm in the hand for at least 8 minutes prior to administration; artificial warming methods should NOT be used. Inspect solution to verify complete mixing of the suspension; do not shake; if settling occurs during storage, gently swirl. Slowly draw dose into a syringe using a 20-gauge or larger needle, taking care to avoid excessive foaming. Suction neonate prior to administration.
Endotracheal tube: Note: Utilized for INSURE (INtubation-SURfactant-Extubation) technique or patients who are mechanically ventilated.
Before administering, ensure proper placement and patency of the endotracheal tube. Patient may be suctioned prior to administration. The neonate should be stable before proceeding with administration. Insert a 5-French end-hole catheter into the neonate's endotracheal tube. Administer the dose in four 1 mL/kg aliquots. Each quarter-dose is instilled over 2 to 3 seconds followed by at least 30 seconds of manual ventilation or until stable; each quarter-dose is administered with the neonate in a different position; slightly downward inclination with head turned to the right, then repeat with head turned to the left; then slightly upward inclination with head turned to the right, then repeat with head turned to the left. Following administration of one full dose, withhold suctioning for 1 hour unless signs of significant airway obstruction. Beractant has also been administered in 2 equal aliquots in 2 positions (inclined to the right and inclined to the left) as well as a single aliquot in a neutral position (Ref).
Intratracheal: Minimally invasive surfactant therapy (MIST)/less invasive surfactant administration (LISA): Administration via a thin feeding catheter (3-French to 5-French) or a semi-rigid 16-gauge vascular catheter that is placed under direct laryngoscopy has also been reported in studies. Surfactant dose is administered over 1 to 3 minutes as small boluses; administration should be slowed if apnea, bradycardia, desaturation, or surfactant reflux occurs (Ref).
Respiratory distress syndrome: Prevention of respiratory distress syndrome (RDS) in premature neonates with birth weight <1,250 g or with evidence of surfactant deficiency (administer within 15 minutes of birth); treatment of RDS in neonates with x-ray confirmation of RDS and requiring mechanical ventilation (administer within 8 hours of birth).
Survanta may be confused with Sufenta
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy
Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification
Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination
Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy
Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification
Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Beractant is only indicated for use in premature neonates
Beractant is only indicated for use in premature neonates
Continuous heart rate and peripheral O2 saturation should be monitored during administration; peripheral O2 saturation, transcutaneous CO2, with confirmatory blood gas analysis as needed following administration to prevent postdosing hyperoxia and hypocarbia. If mechanically ventilated, monitor respiratory parameters to minimize volutrauma following improvement in lung compliance.
Replaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS) or in neonates at risk of developing RDS. Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces.
Onset of action: Improved oxygenation: Within minutes
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