Dosage guidance:
Dosage form information: 1 mL of poractant alfa contains 76 mg of phospholipids.
Respiratory distress syndrome (RDS), treatment: Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using continuous positive airway pressure (CPAP) immediately after birth with subsequent selective surfactant administration (AAP [Polin 2014]).
Endotracheal administration: Note: Use for INSURE (INtubation-SURfactant-Extubation) technique or patients requiring invasive respiratory support (eg, mechanical ventilation):
Preterm neonates: Endotracheal: Initial: 2.5 mL/kg/dose following a diagnosis of significant RDS; if patient remains intubated and continues to require oxygen to maintain adequate oxygenation, may administer 1.25 mL/kg/dose at 12-hour intervals for up to 2 additional doses.
Less invasive methods of surfactant administration:
Minimally invasive surfactant therapy (MIST)/less invasive surfactant administration (LISA): Limited data available; optimal dose not established: Note: Use in patients requiring noninvasive respiratory support.
Preterm neonates: Intratracheal: 1.25 to 2.5 mL/kg/dose; dosing based on trials that included infants with GA 24 to <36 weeks; most studies allowed for repeat doses of 1.25 mL/kg if progressive RDS symptoms were noted and/or FiO2 ≥30% (Aguar 2014; Bensouda 2022; Dargaville 2013; Göpel 2011; Kanmaz 2013; Kribs 2015; Truong 2023).
Laryngeal mask airway (LMA): Preterm neonates weighing ≥1 kg: Intratracheal: 2.5 mL/kg/dose administered in 1 to 2 mL aliquots; dosing from trials that included infants with GA 28 to <36 weeks; a repeat dose may be administered if progressive RDS symptoms and/or increased FiO2 requirements are noted (Amini 2019; Barbosa 2017; Guthrie 2021; Roberts 2018).
Dosage guidance:
Dosage form information: 1 mL of poractant alfa contains 76 mg of phospholipids.
Respiratory distress syndrome (RDS), treatment: Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using continuous positive airway pressure (CPAP) immediately after birth with subsequent selective surfactant administration (AAP [Polin 2014]).
Endotracheal administration: Note: Use for INSURE (INtubation-SURfactant-Extubation) technique or patients requiring invasive respiratory support (eg, mechanical ventilation):
Preterm neonates: Endotracheal: Initial: 2.5 mL/kg/dose following a diagnosis of significant RDS; if patient remains intubated and continues to require oxygen to maintain adequate oxygenation, may administer 1.25 mL/kg/dose at 12-hour intervals for up to 2 additional doses.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
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.
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
Suspension (Curosurf Intratracheal)
120 mg/1.5 mL (per mL): $456.79
240 mg/3 mL (per mL): $450.36
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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]
Each mL of poractant alfa contains 76 mg of phospholipids as well as 1 mg of surfactant-associated proteins including 0.45 mg of SP-B and 0.59 mg of SP-C.
Endotracheal/Intratracheal: Take from refrigerator and slowly 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 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 tube: Note: Utilized for INSURE (INtubation-SURfactant-Extubation) technique or patients who are mechanically ventilated.
Before administering, ensure proper placement and patency of the endotracheal tube. The endotracheal tube may be suctioned before administering the poractant alfa. The drug is administered through a 5-French end-hole catheter in 2 equally divided aliquots or through the proximal end of a secondary lumen of the endotracheal tube as a single dose over 1 minute (without interrupting mechanical ventilation). Each aliquot is administered with the neonate's head and body in a neutral position, with either the right or left side dependent; after each aliquot is administered, manually ventilate until clinically stable. Do not suction airways for 1 hour after instillation unless signs of significant airway obstruction occur.
Intratracheal:
Minimally Invasive Surfactant Therapy (MIST)/less invasive surfactant administration (LISA): Limited data available: Administration via a thin, soft catheter (2.5-French to 5-French) has been suggested as a less invasive method; use of a semi-rigid 16-gauge vascular catheter has also been reported. The catheter is placed between the vocal cords under direct laryngoscopy to desired length and the surfactant dose is administered over 1 to 5 minutes as small boluses; administration should be slowed if apnea, bradycardia, desaturation, or surfactant reflux occurs (Aguar 2014; Bensouda 2022; Dargaville 2013; Göpel 2011; Herting 2020; Kanmaz 2013; Kribs 2015; Truong 2023).
Laryngeal mask airway (LMA): Limited data available: Administer directly into LMA lumen via syringe attached to the LMA or via a catheter inserted into the LMA. Surfactant is administered in 1 to 2 mL aliquots followed by bag ventilation after each aliquot (Devi 2022; Roberts 2018; Zapata 2022).
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) (FDA approved in 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 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 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
Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
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, blood pressure, and oxygen saturation should be monitored during administration; oxygen saturation with confirmatory blood gas analysis as needed following administration to prevent postdosing hyperoxia and hypocarbia. If mechanically ventilated, monitor respiratory parameters to minimize volutrauma following improvement in lung compliance.
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.
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