Respiratory distress syndrome (RDS), treatment:
Manufacturer's labeling: Preterm newborns: Endotracheal: Initial: 2.5 mL/kg/dose (200 mg/kg/dose); may repeat 1.25 mL/kg/dose (100 mg/kg/dose) at 12-hour intervals for up to 2 additional doses; maximum total dose: 5 mL/kg
Alternate dosing: Minimally invasive surfactant therapy (MIST) for patients spontaneously breathing: Limited data available: Intratracheal: 1.25 mL/kg/dose (100 mg/kg/dose); dosing based on multiple trials in neonates on nasal CPAP for RDS treatment (total n=264); eligible patients ranged in gestational age from 24 to <36 weeks; most studies allowed for repeat doses if necessary; rates of mechanical ventilation and oxygen use were often decreased within the first 72 hours of life compared to patients receiving traditional endotracheal tube administration; bronchopulmonary dysplasia rates were similar between the groups and decreased with MIST in one study (Aguar 2014; Dargaville 2013; Göpel 2011; Kanmaz 2013). One study utilized 2.5 mL/kg/dose (200 mg/kg/dose) in a small number of patients (n=7; GA: 25 to 28 weeks); no patients in this group required intubation within 72 hours as compared to 39% of patients receiving the lower dose; however, this was not statistically significant (Dargaville 2013).
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
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
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]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intratracheal:
Curosurf: 80 mg/mL (1.5 mL, 3 mL) [contains sodium chloride]
Endotracheal/Intratracheal: 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.
Endotracheal: 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 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).
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 to 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 to 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.
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.
Intratracheal: Administration for spontaneously breathing newborns who do not require endotracheal intubation: Minimally Invasive Surfactant Therapy (MIST): Limited data available: Administration via a thin catheter (2.5- to 5-French) has been suggested as a less invasive method. The catheter is placed between the vocal cords under direct laryngoscopy and the surfactant dose is administered over 1 to 3 minutes. In some studies, premedication with atropine was used (Aguar 2014; Dargaville 2013; Gopel 2011; Kanmaz 2013).
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.
Treatment of respiratory distress syndrome (RDS) in premature infants (FDA approved in newborns)
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
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.
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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: 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. Risk D: Consider therapy modification
Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination
Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy
Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification
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. Risk D: Consider therapy modification
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
This drug is not indicated for use in adults.
Continuous heart rate and transcutaneous O2 saturation should be monitored during administration; frequent ABG sampling is necessary to prevent postdosing hyperoxia and hypocarbia
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.
Information limited to animal models. No human pharmacokinetic information is available.
Poractant alfa contains surfactant-associated proteins SP-B (0.45 mg/mL) and SP-C (0.59 mg/mL).
Suspension (Curosurf Intratracheal)
120 mg/1.5 mL (per mL): $406.96
240 mg/3 mL (per mL): $401.24
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