What is Poractant alfa (monograph)?
Introduction
Exogenous natural pulmonary surfactant preparation; porcine lung extract containing mostly phospholipids.
Uses for Poractant Alfa
Respiratory Distress Syndrome (RDS)
Treatment (rescue) of RDS (hyaline membrane disease) in premature neonates (designated an orphan drug by FDA for this use).
Prevention† [off-label] of RDS in infants at high risk for RDS.
Poractant Alfa Dosage and Administration
General
-
Observe clinical status and monitor systemic oxygenation frequently; decrease inspired oxygen concentrations and ventilator pressures gradually to prevent hyperoxia.
-
Following completion of dosing procedure, resume usual ventilator management and clinical care. Do not suction airways for 1 hour after dosing unless substantial obstruction occurs. (See Experience of Supervising Clinician under Cautions.)
Administration
Intratracheal Administration
Administer only by intratracheal instillation using specialized techniques. Consult manufacturer’s labeling or specialized references for guidelines on administration techniques.
Allow drug to reach room temperature before administration. Gently invert vial to obtain a uniform suspension; do not shake.
Contains no preservatives; discard unused portion.
Dosage
Available as poractant alfa; dosage expressed in terms of phospholipids.
Each mL of the commercially available formulation contains 80 mg of phospholipids (including 54 mg of phosphatidylcholine, of which 30.5 mg is dipalmitoyl phosphatidylcholine) and 1 mg of surfactant proteins (SP-B, SP-C).
Pediatric Patients
Treatment of RDS
Intratracheal
Premature neonates: 2.5 mL/kg (200 mg/kg) of birthweight.
Administer up to 2 repeat doses (1.25 mL/kg of birth weight), given at 12-hour intervals, if neonate remains intubated and respiratory manifestations of RDS persist or worsen.
Prevention of RDS† [off-label]
Intratracheal
100 or 200 mg/kg, given as a single dose within 10 minutes of birth.
Prescribing Limits
Pediatric Patients
Treatment of RDS
Intratracheal
Premature neonates: Total dosage (initial and repeat doses) should not exceed 5 mL/kg. Safety and efficacy not established for administration of >3 doses (1 initial and 2 repeat doses), administration more frequently than every 12 hours, and initiation of therapy >15 hours after diagnosis of RDS.
Related/similar drugs
Surfaxin, Curosurf, beractant, poractant, lucinactantWarnings
Contraindications
-
No known contraindications.
Warnings/Precautions
Warnings
Experience of Supervising Clinician
Use only by clinicians experienced in resuscitation, stabilization, and general care of premature neonates.
Respiratory Effects
Therapy can rapidly affect oxygenation and lung compliance. Perform frequent clinical and laboratory assessments; modify oxygen and ventilatory support in response to respiratory changes.
Transient episodes of decreased oxygen saturation reported. If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.
Cardiovascular Effects
Transient episodes of bradycardia and hypotension reported. If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.
Endotracheal Tube Complications
Transient endotracheal tube blockage, reflux of surfactant into endotracheal tube, and airway obstruction reported. If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.
General Precautions
Concurrent Illness
Correction of acidosis, hypotension, anemia, hypoglycemia, and hypothermia recommended prior to administration.
Complications of Prematurity
Therapy expected to reduce severity of RDS but will not eliminate morbidity and mortality associated with other complications of prematurity (e.g., pneumonia, septicemia, intracranial hemorrhage, patent ductus arteriosus).
Use with Investigational Treatments for RDS
Safety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation) not established.
Specific Populations
Pregnancy
Not intended for use in adults.
Lactation
Not intended for use in adults.
Common Adverse Effects
Transient bradycardia, hypotension, endotracheal tube blockage, decreased oxygen saturation.
How should I use Poractant alfa (monograph)
General
-
Observe clinical status and monitor systemic oxygenation frequently; decrease inspired oxygen concentrations and ventilator pressures gradually to prevent hyperoxia.
-
Following completion of dosing procedure, resume usual ventilator management and clinical care. Do not suction airways for 1 hour after dosing unless substantial obstruction occurs. (See Experience of Supervising Clinician under Cautions.)
Administration
Intratracheal Administration
Administer only by intratracheal instillation using specialized techniques. Consult manufacturer’s labeling or specialized references for guidelines on administration techniques.
Allow drug to reach room temperature before administration. Gently invert vial to obtain a uniform suspension; do not shake.
Contains no preservatives; discard unused portion.
Dosage
Available as poractant alfa; dosage expressed in terms of phospholipids.
Each mL of the commercially available formulation contains 80 mg of phospholipids (including 54 mg of phosphatidylcholine, of which 30.5 mg is dipalmitoyl phosphatidylcholine) and 1 mg of surfactant proteins (SP-B, SP-C).
Pediatric Patients
Treatment of RDS
Intratracheal
Premature neonates: 2.5 mL/kg (200 mg/kg) of birthweight.
Administer up to 2 repeat doses (1.25 mL/kg of birth weight), given at 12-hour intervals, if neonate remains intubated and respiratory manifestations of RDS persist or worsen.
Prevention of RDS† [off-label]
Intratracheal
100 or 200 mg/kg, given as a single dose within 10 minutes of birth.
Prescribing Limits
Pediatric Patients
Treatment of RDS
Intratracheal
Premature neonates: Total dosage (initial and repeat doses) should not exceed 5 mL/kg. Safety and efficacy not established for administration of >3 doses (1 initial and 2 repeat doses), administration more frequently than every 12 hours, and initiation of therapy >15 hours after diagnosis of RDS.