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Poractant Alfa

Medically reviewed by Drugs.com. Last updated on Sep 9, 2020.

Pronunciation

(por AKT ant AL fa)

Index Terms

  • Porcine Lung Surfactant

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intratracheal [preservative free]:

Curosurf: 120 mg/1.5 mL (1.5 mL); 240 mg/3 mL (3 mL) [contains sodium chloride]

Brand Names: U.S.

  • Curosurf

Pharmacologic Category

  • Lung Surfactant

Pharmacology

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in respiratory distress syndrome characterized by poor lung expansion, inadequate gas exchange, and atelectasis. Poractant alfa compensates for the surfactant deficiency and restores surface activity to the infant's lungs. It reduces mortality and pneumothoraces associated with RDS.

Use: Labeled Indications

Respiratory distress syndrome (RDS): Treatment (rescue) of respiratory distress syndrome (RDS) in premature infants; reduces mortality and pneumothoraces associated with RDS.

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to poractant alfa or any component of the formulation.

Dosing: Pediatric

Note: For intratracheal use only

Respiratory distress syndrome (RDS): Neonates: Intratracheal: Initial: 2.5 mL/kg of birth weight. May administer up to 2 additional doses of 1.25 mL/kg birth weight at 12-hour intervals if needed for infants who continue to require mechanical ventilation and supplemental oxygen. Maximum total dose: 5 mL/kg birth weight

Storage

Store under refrigeration at defined temperature of 2°C to 8°C (36°F to 46°F). Unopened, unused vials that have been warmed to room temperature can be returned to refrigerator storage within 24 hours for future use. Do not warm and then refrigerate more than once. Vials are for single use only. Protect from light. Do not shake.

Drug Interactions

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Consider therapy modification

Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Avoid combination

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Consider therapy modification

Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

All reported adverse reactions occurred in premature neonates as safety and efficacy has not been established in full term neonates and older pediatric patients with respiratory failure. Frequency not always defined.

Cardiovascular: Patent ductus arteriosus (60%), bradycardia, hypotension

Hematologic & oncologic: Oxygen desaturation

Miscellaneous: Obstruction of endotracheal tube

<1%, postmarketing, and/or case reports: Pulmonary hemorrhage

Warnings/Precautions

Concerns related to adverse effects:

• Pulmonary hemorrhage: Pulmonary hemorrhage is a known complication of premature birth and very low birth-weight. It has been reported in both clinical trials and postmarketing reports in infants who have received poractant alfa.

• Transient adverse effects: Transient episodes of bradycardia, decreased oxygen saturation, hypotension, or endotracheal tube blockage 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; 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.

Monitoring Parameters

Arterial blood gases, ventilator measurement assessment

Pregnancy Considerations

This drug is not indicated for use in adults.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.