Version July 2025
(For additional information see "Calfactant: Pediatric drug information")
Dosage guidance:
Dosage form information: 1 mL of calfactant contains 35 mg of phospholipid.
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 (INtubation-SURfactant-Extubation) technique or patients requiring invasive respiratory support (eg, mechanical ventilation):
Newborns ≤72 hours: Endotracheal: 3 mL/kg as soon as the diagnosis of RDS is made; additional doses may be administered if patient remains intubated and requires at least 30% inspired fraction of oxygen (FiO2) to maintain a PaO2 ≤80 torr; 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).
Premature newborns (<29 weeks gestation): Endotracheal: 3 mL/kg as soon as possible after birth, preferably within 30 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.
>10%:
Cardiovascular: Bradycardia (34%)
Gastrointestinal: Endotracheal tube reflux (21%)
Respiratory: Airway obstruction (39%), cyanosis (65%)
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 resume treatment with appropriate monitoring.
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; calfactant should only be administered by clinicians trained and experienced in the care, resuscitation, and stabilization of preterm neonates with respiratory distress syndrome who require intubation.
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
Suspension (Infasurf Intratracheal)
35 mg/mL 0.9% (per mL): $211.18
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Gently swirl vial to redisperse suspension; do not shake. Slowly draw dose into a syringe using a 20-gauge or larger needle taking care to avoid excessive foaming. Warming of vial prior to administration is not necessary.
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. Administer dose in 2 equally divided aliquots into the endotracheal tube either via a side-port adapter into the endotracheal tube or via a 5-French feeding catheter inserted 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 2 aliquots; calfactant dosage has also been divided into 4 equal aliquots and administered with repositioning in 4 different positions (prone, supine, right and left lateral).
Intratracheal: Minimally invasive surfactant administration (MISA): Administration via a thin catheter (eg, 3-French 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 5 minutes as small boluses; administration should be slowed if apnea, bradycardia, or surfactant reflux occurs (Ref).
Nebulization: Administer via a Solarys nebulizer with a distal end resembling a pacifier inserted into the mouth of the patient. The rate of delivery was 0.2 ± 0.02 mL/minute continuously, not synchronized with inspiration (Ref).
Respiratory distress syndrome: Reduce risk of respiratory distress syndrome (RDS) in premature neonates <29 weeks gestational age; rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Bradycardia-Causing Agents: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Ceritinib: Bradycardia-Causing Agents may increase bradycardic effects 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 increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Fexinidazole: Bradycardia-Causing Agents may increase arrhythmogenic effects of Fexinidazole. Risk X: Avoid
Fingolimod: Bradycardia-Causing Agents may increase bradycardic effects 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 increase bradycardic effects of Ivabradine. Risk C: Monitor
Lacosamide: Bradycardia-Causing Agents may increase AV-blocking effects of Lacosamide. Risk C: Monitor
Landiolol: Bradycardia-Causing Agents may increase bradycardic effects of Landiolol. Risk X: Avoid
Midodrine: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Ozanimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Ponesimod: Bradycardia-Causing Agents may increase bradycardic effects 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 increase bradycardic effects 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
Continuous heart rate and transcutaneous O2 saturation should be monitored during administration; transcutaneous CO2 and blood gases following administration 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
