Overview
11 DESCRIPTION Calfactant is an extract of natural bovine lung (pulmonary) surfactant consisting of 85% phospholipids, 8% neutral lipids, and 7% hydrophobic surfactant-associated proteins B and C (SP-B and SP-C). The molecular weight of SP-B is 8.7 kDa and the molecular weight of SP-C is 3.7 kDa.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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 preterm neonates. INFASURF is a lung surfactant that restores lung surface activity in preterm neonates with RDS by adsorbing to the surface of the air:liquid interface and modifying surface tension similarly to natural lung surfactant. 12.2 Pharmacodynamics Calfactant dose-response relationships and the time course of pharmacodynamic response are unknown. In vitro, INFASURF lowered minimum surface tension to ≤ 3 mN/m as measured on a pulsating bubble surfactometer.
Indications
- 1 INDICATIONS AND USAGE INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates
Common Doses
- 3 mL
- 1.5 mL
- 0.75 mL
Dosage
2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dose of INFASURF is 3 mL/kg body weight at birth administered intratracheally through an endotracheal tube. INFASURF can be administered every 12 hours for a total of up to three doses. To reduce the risk of RDS in preterm neonates
Contraindications
- 4 CONTRAINDICATIONS None. None.
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Acute Changes in Oxygenation and Lung Compliance [ see Warnings and Precautions (5.1 )] Administration-Related Adverse Reactions [see Warnings and Precautions (5.2) ] Intraventricular Hemorrhage and Periventricular Leukomalacia [ see Warnings and Precautions (5.3) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.