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]
Pharmacology
Mechanism of Action
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.
Dosage and Administration
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. Exceptions are discussed in separate monographs. 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. 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
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
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 slow heartbeat, 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.
