Calfactant

R07A - Other respiratory system products ATC R07AA02 Unknown approved 1998 Parenteral

JFDA label: Infasurf 6ml suspension Vial

Mechanism of Action

— Surfactant agent

Indications

Approved

Respiratory distress syndrome

Contraindications

Source: Lexicomp

There are no contraindications listed in the manufacturer's labeling Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (1)

Very Common Bradycardia

Gastrointestinal disorders (1)

Very Common Endotracheal tube reflux

Respiratory, thoracic and mediastinal disorders (2)

Very Common airway obstruction · Cyanosis

Dosing

Source: Lexicomp

(For additional information see "Calfactant: Pediatric drug information") Respiratory distress syndrome (RDS): Prophylactic therapy: Premature newborns (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.

Warnings & Precautions

Source: Lexicomp

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.

Pregnancy & Lactation

Pregnancy

Monitoring

Clinical pearl	Continuous heart rate and transcutaneous O2 saturation should be monitored during administration; frequent ABG sampling is necessary to prevent postdosing hyperoxia and hypocarbia

Registered Products (2)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Infasurf 3 ml suspension Vial	Suspension 35 mg/1 ml, 0.7 mg/1 ml	3 ml pack varies	The Medical Drugstore Company for Medical and Nutritional Projects	—
Infasurf 6ml suspension Vial	Suspension 35 mg/1 ml, 0.7 mg/1 ml	6 ml pack varies	The Medical Drugstore Company for Medical and Nutritional Projects	—