Respiratory distress syndrome (RDS): Limited data available in premature neonates <600 g or >1,750 g:
Prophylactic therapy: Premature neonates: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as possible after birth preferably within 15 minutes; as many as 4 doses may be administered during the first 48 hours of life, no more frequently than every 6 hours; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]). The need for additional doses is determined by evidence of continuing respiratory distress or if the neonate is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr. Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using CPAP immediately after birth with subsequent selective surfactant administration (AAP [Polin 2014]).
Rescue treatment:
Manufacturer's labeling: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as the diagnosis of RDS is made; may repeat if needed, no more frequently than every 6 hours to a maximum of 4 doses during the first 48 hours of life; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]). The need for additional doses is determined by evidence of continuing respiratory distress or if the neonate is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr.
Alternate dosing: Minimally invasive surfactant therapy (MIST)/less invasive surfactant application (LISA) for patients spontaneously breathing: Limited data available: Intratracheal: 4 mL/kg (100 mg phospholipids/kg); dosing based on a trial in neonates on nasal CPAP for RDS treatment (n=29); eligible patients ranged in gestational age from 23 to 27 weeks; an additional dose was allowed after 12 to 24 hours if FiO2 ≥40% was needed to maintain oxygen saturation >85% (Kribs 2007)
Meconium aspiration syndrome (MAS), severe: Limited data available: Term newborns: Endotracheal: 4 to 6 mL/kg (100 to 150 mg phospholipids/kg); repeat every 6 hours up to a total of 4 doses. Dosing based on two randomized, placebo-controlled trials. The larger trial compared surfactant treatment at a dose of 4 mL/kg (100 mg/kg) in 167 infants with respiratory failure (including 87 with MAS) (GA: 39 ± 1.8 weeks; PNA: 31 ± 22 hours) with a control group who received room air; the surfactant group had a lower need for ECMO compared to the control group (36.8% vs 51.9% for the MAS patients) without an increase in pulmonary complications (Lotze 1998). A smaller trial (n=20; GA: 40.2 ± 0.3 weeks) administered a higher dose of 6 mL/kg (150 mg/kg) of surfactant earlier after delivery (ie, during the first 6 hours of life); compared to the control group who received room air, the surfactant group had a significantly lower need for ECMO (5% vs 30%, p=0.037), no air leaks (0% vs 25%, p=0.024), shorter duration of mechanical ventilation (7.7 days vs 10.8 days, p=0.047), shorter duration of oxygen therapy (13 days vs 19.6 days, p=0.031), and a shorter duration of admission (15.9 days vs 24.3 days, p=0.003) (Findlay 1996).
Respiratory distress treatment: Premature neonates: Limited data available in premature neonates <600 g or >1,750 g:
Prophylactic therapy: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as possible after birth, preferably within 15 minutes; as many as 4 doses may be administered during the first 48 hours of life, no more frequently than 6 hours apart; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]). The need for additional doses is determined by evidence of continuing respiratory distress; if the neonate is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr. Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using CPAP immediately after birth with subsequent selective surfactant administration (AAP [Polin 2014]).
Rescue treatment: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as the diagnosis of RDS is made; may repeat if needed, no more frequently than every 6 hours to a maximum of 4 doses during the first 48 hours of life; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]). The need for additional doses is determined by evidence of continuing respiratory distress or if the neonate is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
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
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. Suction infant prior to administration.
Endotracheal: Administration to through endotracheal tube using a 5-French end-hole catheter: The infant should be stable before proceeding with administration. Insert a 5-French end-hole catheter into the infant'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 infant 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.
Intratracheal: Administration method for spontaneously breathing newborns who do not require endotracheal intubation: Minimally invasive surfactant therapy (MIST): Limited data available: Administration via a thin catheter (2.5- to 5-French) has been suggested as a less invasive method. The catheter is placed between the vocal cords under direct laryngoscopy and the surfactant dose is administered over 1 to 3 minutes. In some studies, premedication with atropine was used (Kribs 2007).
Store intact vials at 2°C to 8°C (36°F to 46°F); protect from light and store vials in original carton until ready for use. Unopened, unused vials that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming and stored for future use. Do not remove vial from the refrigerator for >24 hours; do not warm and return to refrigerator more than once.
Prevention of respiratory distress syndrome (RDS) in premature neonates with birth weight <1,250 g or with evidence of surfactant deficiency (FDA approved in newborns); treatment of RDS in neonates with x-ray confirmation of RDS and requiring mechanical ventilation (FDA approved in newborns); has also been used for treatment of meconium aspiration syndrome in term and near-term newborns
Survanta may be confused with Sufenta
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.
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.
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
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
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
Continuous heart rate and transcutaneous O2 saturation should be monitored during administration; frequent ABG sampling is necessary to prevent postdosing hyperoxia and hypocarbia.
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
Beractant contains surfactant-associated proteins SP-B and SP-C (<1 mg/mL).
Suspension (Survanta Intratracheal)
25 mg/mL 0.9% (per mL): $114.90
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