Respiratory distress syndrome (RDS):
Prophylactic therapy: Premature newborns (<29 weeks' gestation): Endotracheal: 3 mL/kg as soon as possible after birth, preferably within 30 minutes; additional doses may be given every 12 hours up to a total of 3 doses. In studies, repeat doses have been administered as frequently as every 6 hours for a total of up to 4 doses if the neonate was still intubated and required at least 30% inspired oxygen to maintain arterial oxygen saturations >90% or with a PaO2 ≤80 torr on >30% inspired oxygen (Bloom 2005; Kattwinkel 2000). However, guidelines suggest that dosing intervals more frequent than every 12 hours should not be necessary, unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]).
Rescue treatment: Newborns ≤72 hours: Endotracheal: 3 mL/kg as soon as the diagnosis of RDS is made; additional doses may be given every 12 hours up to a total of 3 doses. In studies, repeat doses have been administered as frequently as every 6 hours for a total of up to 4 doses if the neonate was still intubated and required at least 30% inspired oxygen to maintain arterial oxygen saturations >90% or with a PaO2 ≤80 torr on >30% inspired oxygen (Bloom 2005; Kattwinkel 2000). However, guidelines suggest that dosing intervals more frequent than every 12 hours should not be necessary, unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]).
Respiratory distress syndrome (RDS):
Prophylactic therapy: Premature newborns (<29 weeks gestation): Endotracheal: 3 mL/kg every 12 hours up to a total of 3 doses. In studies, repeat doses have been administered as frequently as every 6 hours for a total of up to 4 doses if the neonate was still intubated and required at least 30% inspired oxygen to maintain arterial oxygen saturations >90% or with a PaO2 ≤80 torr on >30% inspired oxygen (Bloom 2005; Kattwinkel 2000). However, guidelines suggest that dosing intervals more frequent than every 12 hours should not be necessary, unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]).
Rescue treatment: Newborns: Endotracheal: 3 mL/kg every 12 hours up to a total of 3 doses. In studies, repeat doses have been administered as frequently as every 6 hours for a total of up to 4 doses if the neonate was still intubated and required at least 30% inspired oxygen to maintain arterial oxygen saturations >90% or with a PaO2 ≤80 torr on >30% inspired oxygen (Bloom 2005; Kattwinkel 2000). However, guidelines suggest that dosing intervals more frequent than every 12 hours should not be necessary, unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]).
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:
Infasurf: 35 mg phospholipids and 0.7 mg protein per mL (3 mL, 6 mL)
No
Endotracheal tube administration: Gently swirl to redisperse suspension; do not shake; administer dosage divided into two aliquots of 1.5 mL/kg each into the endotracheal tube; after each instillation, reposition the infant with either the right or left side dependent; administration is made while ventilation is continued over 20 to 30 breaths for each aliquot, with small bursts timed only during the inspiratory cycles; a pause followed by evaluation of the respiratory status and repositioning should separate the two aliquots; calfactant dosage has also been divided into four equal aliquots and administered with repositioning in four different positions (prone, supine, right and left lateral).
Gentle swirling or agitation of the vial of suspension is often necessary for redispersion. Do not shake. Visible flecks of the suspension and foaming under the surface are normal. Calfactant should be stored upright (3 mL vial) and under refrigeration at 2°C to 8°C (36°F to 46°F); protect from light; document date and time removed from refrigeration. Warming before administration is not necessary. Unopened and unused vials of calfactant that have been warmed to room temperature can be returned to refrigeration storage within 24 hours for future use. Repeated warming to room temperature should be avoided. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.
Prevention of respiratory distress syndrome (RDS) in premature infants at significant risk (FDA approved in newborns <29 weeks gestational age); treatment of RDS in neonates with clinical and radiologic confirmation and requiring mechanical ventilation (FDA approved in newborns ≤72 hours of age)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Bradycardia (34%)
Gastrointestinal: Endotracheal tube reflux (21%)
Respiratory: Cyanosis (65%), airway obstruction (16% to 39%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Transient adverse effects: Transient episodes of bradycardia, decreased oxygen saturation, endotracheal tube blockage or reflux of calfactant into endotracheal tube may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable.
Other warnings/precautions:
• Administration: For intratracheal administration only.
• Monitoring: Produces rapid improvements in lung oxygenation and compliance that may require frequent adjustments to oxygen delivery and ventilator settings.
• 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 infants.
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
Continuous heart rate and transcutaneous O2 saturation should be monitored during administration; frequent ABG sampling is necessary to prevent postdosing hyperoxia and hypocarbia
Endogenous lung surfactant is essential for effective ventilation because it modifies alveolar surface tension, thereby stabilizing the alveoli. Lung surfactant deficiency is the cause of respiratory distress syndrome (RDS) in premature infants and lung surfactant restores surface activity to the lungs of these infants.
No human studies of absorption, biotransformation, or excretion have been performed
Calfactant contains surfactant-associated proteins SP-B and SP-C (0.7 mg/mL protein, including 0.26 mg/mL SP-B).
Suspension (Infasurf Intratracheal)
35 mg/mL 0.9% (per mL): $181.79
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