Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Calfactant is a lung Surfactant
Calfactant is used in the Treatment of Respiratory distress syndrome.
Calfactant is administered directly to the lung lumen surface where it acts. No human studies on absorption have been completed.
Calfactant shows common side effects like Chest pain, coughing or spitting up blood, dark-colored urine, decreased appetite, fever, general feeling of tiredness
Calfactant is available in the form of Suspension.
Calfactant is available in India, Germany, Canada, and Italy.
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.
Calfactant is available in the form of Suspension .
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).
Calfactant is used in the Treatment of Respiratory distress syndrome.
Calfactant is an extract of natural surfactant obtained from calf lungs which include phospholipids, neutral lipids, and hydrophobic surfactant-associated proteins B and C. It acts similarly to endogenous lung surfactant by rapidly adsorbing to the surface of the air:liquid interface and modifying the surface tension. It stabilises the alveoli by modifying alveolar surface tension.
Calfactant is approved for use in the following clinical indications
Respiratory distress syndrome: Prevention of respiratory distress syndrome (RDS) in premature infants <29 weeks gestational age at significant risk; treatment of RDS in neonates ≤72 hours of age with clinical and radiologic confirmation and requiring mechanical ventilation
Calfactant is available in various strengths as 3 mL, 6 mL
- Dosage Adjustment in Hepatic impairment Patient
Mild impairment: No dosage adjustment necessary.
Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling
● Dosage Adjustment for Pediatric Patients
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 torrs 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 torrs 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
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.
Alcohol Warning
Calfactant is only indicated for use in premature neonates.
Breast Feeding Warning
Calfactant is only indicated for use in premature neonates.
Pregnancy Warning
Calfactant is only indicated for use in premature neonates.
Food Warning
A high-fat meal may decrease the rate but not the extent of absorption. Management: May administer with meals.
- Common Adverse effects
Transient bradycardia and oxygen desaturation; increased risk of nosocomial sepsis (post-treatment); transient rales and moist breath sounds; endotracheal tube obstruction by mucous secretions.
- Less Common Adverse effects:
Hypertension, hypotension, vasoconstriction.
- Rare Adverse effects
Pallor, hypocapnia, hypercapnia, apnoea, endotracheal tube reflux.
The common side effects of Calfactant include the following Airway obstruction, cyanosis, bradycardia, drug reflux into the endotracheal tube; intraventricular haemorrhage, periventricular leucomalacia.
Pharmacodynamic
Pulmonary surfactant is an endogenous substance produced in the lungs that functions to decrease surface tension in the air: fluid interface on the alveolar surface. In premature infants with pulmonary surfactant deficiency, surface tension can increase to the point where sections of lung collapse and respiratory distress syndrome (RDS) develop. Calfactant adsorbs rapidly to the surface of the alveolar air: fluid interface and modifies surface tension to a minimum of fewer than 3 mN/m. It acts in a manner similar to natural lung surfactant, thus preventing or treating respiratory distress syndrome.
Pharmacokinetics
NA.
- https://pubmed.ncbi.nlm.nih.gov/1091001/
- https://clinicaltrials.gov/ct2/show/NCT01422915
- https://clinicaltrials.gov/ct2/show/NCT02263547
- https://www.medicines.org.uk/emc/product/128/smpc.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1364710/
- https://reference.medscape.com/drug/colestid-Calfactant -342452
- https://go.drugbank.com/drugs/DB00375
- https://www.sciencedirect.com/topics/medicine-and-dentistry/Calfactant
- https://europepmc.org/article/med/6988203
