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Poractant Alfa

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, Inhalation [preservative free]:

Curosurf: 80 mg/mL (1.5 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.

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

Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Reconstitution

Prior to administration, warm suspension to room temperature. Gently turn the vial over to obtain a uniform suspension; do not shake.

Administration

Take from refrigerator and warm to room temperature. Inspect for discoloration. The color should be white to creamy white. Gently turn the vial upside down to get a uniform suspension. Do not shake. Slowly withdraw the entire contents into a 3 mL or 5 mL plastic syringe through a large gauge needle (at least 20 gauge); discard the excess through the catheter so that only the total dose to be given remains in the syringe.

Before administering, assure proper placement and patency of the endotracheal tube. The endotracheal tube may be suctioned before administering the poractant alpha. The drug is administered intratracheally through a 5-French end-hole catheter cut to a standard length of 8 cm or through a secondary lumen of a dual-lumen endotracheal tube (without interrupting mechanical ventilation). Up to 2 repeated doses may be administered, using the same technique at 12-hour intervals.

Administration using a 5-French end-hole catheter: The infant should be stable before proceeding with administration. Keep the head and body of the infant in alignment without inclination and with either the right or left side dependent. Prior to administration, the infant's ventilator settings should be changed to a rate of 40-60 breaths/minute, inspiratory time 0.5 seconds, and supplemental oxygen to maintain SaO2 >92%. Briefly disconnect the endotracheal tube from the ventilator, insert the 5-French catheter. Administer dose in equally 2 divided aliquots. Instill the first aliquot (1.25 mL/kg birth weight for the initial dose; 0.635 mL/kg birth weight for repeat doses), remove the catheter and manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for 1 minute. When the infant is stable, reposition the infant such that the other side is dependent and administer the remaining aliquot (1.25 mL/kg birth weight for the initial dose; 0.635 mL/kg birth weight for repeat doses) using the same technique. Do not suction the airways for 1 hour after instillation unless signs of significant airway obstruction occur. Resume ventilator management and clinical care.

Insert the first aliquot (1.25 mL/kg birth weight) and position the infant so that either the right or left side is dependent for the aliquot. Remove the catheter and manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for 1 minute. When the infant is stable, reposition the infant such that the other side is dependent and administer the remaining aliquot using the same technique. Remove the catheter without flushing. Do not suction the airways for 1 hour after instillation unless signs of significant airway obstruction occur. Resume ventilator management and clinical care.

Administration using the secondary lumen of a dual-lumen endotracheal tube: The infant should be stable before proceeding with dosing. Keep the head and body of the infant in alignment without inclination. Administer poractant through the proximal end of the secondary lumen of the endotracheal tube as a single dose over 1 minute (without interrupting mechanical ventilation); transient increases in F1O2, ventilatory rate, or peak inspiratory pressure (PIP) may be required. Do not suction airways for 1 hour after instillation unless signs of significant airway obstruction occur.

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

Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking 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. 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

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

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

Adverse Reactions

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% (Limited to important or life-threatening): 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.

• 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.

Patient Education

• Discuss specific use of drug and side effects with caregiver as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have caregiver report immediately to prescriber bradycardia, severe dizziness, or passing out (HCAHPS).

• Educate caregiver about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Caregiver should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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