Poractant Alfa
Brand names: Curosurf
Drug class:
Antineoplastic Agents
Usage of 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.
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How to use Poractant Alfa
General
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 IntratrachealPremature 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] Intratracheal100 or 200 mg/kg, given as a single dose within 10 minutes of birth.
Prescribing Limits
Pediatric Patients
Treatment of RDS IntratrachealPremature 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.
Warnings
Contraindications
Warnings/Precautions
Warnings
Experience of Supervising ClinicianUse only by clinicians experienced in resuscitation, stabilization, and general care of premature neonates.
Respiratory EffectsTherapy 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 EffectsTransient 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 ComplicationsTransient 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 IllnessCorrection of acidosis, hypotension, anemia, hypoglycemia, and hypothermia recommended prior to administration.
Complications of PrematurityTherapy 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 RDSSafety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation) not established.
Specific Populations
PregnancyNot intended for use in adults.
LactationNot intended for use in adults.
Common Adverse Effects
Transient bradycardia, hypotension, endotracheal tube blockage, decreased oxygen saturation.
What other drugs will affect Poractant Alfa
No drug interactions reported.
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