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Poractant alfa: Drug information

Poractant alfa: Drug information
(For additional information see "Poractant alfa: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Curosurf
Brand Names: Canada
  • Curosurf
Pharmacologic Category
  • Lung Surfactant
Dosing: Pediatric

(For additional information see "Poractant alfa: Pediatric drug information")

Dosage guidance:

Dosage form information: 1 mL of poractant alfa contains 76 mg of phospholipids.

Respiratory distress syndrome, treatment

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

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

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.

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.

Dosage Forms: US

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]

Generic Equivalent Available: US

No

Pricing: US

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.

Dosage Forms: Canada

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]

Administration: Pediatric

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).

Use: Labeled Indications

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

Metabolism/Transport Effects

None known.

Drug Interactions

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.

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

Pregnancy Considerations

This drug is not indicated for use in adults.

Breastfeeding Considerations

This drug is not indicated for use in adults.

Monitoring Parameters

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.

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.

Pharmacokinetics (Adult Data Unless Noted)

Information limited to animal models. No human pharmacokinetic information is available.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Curosurf;
  • (AR) Argentina: Curosurf;
  • (AT) Austria: Curosurf;
  • (BG) Bulgaria: Curosurf;
  • (BR) Brazil: Curosurf;
  • (CN) China: Curosurf;
  • (CO) Colombia: Curosurf;
  • (CZ) Czech Republic: Curosurf;
  • (DE) Germany: Curosurf;
  • (EE) Estonia: Curosurf;
  • (EG) Egypt: Curosurf;
  • (ES) Spain: Curosurf;
  • (FI) Finland: Curosurf;
  • (FR) France: Curosurf;
  • (GB) United Kingdom: Curosurf;
  • (GR) Greece: Curosurf;
  • (HK) Hong Kong: Curosurf;
  • (HU) Hungary: Curosurf;
  • (IN) India: Curosurf;
  • (IT) Italy: Curosurf;
  • (KR) Korea, Republic of: Curosurf;
  • (LT) Lithuania: Curosurf;
  • (LV) Latvia: Curosurf;
  • (MX) Mexico: Curosurf;
  • (MY) Malaysia: Curosurf;
  • (NO) Norway: Curosurf;
  • (PE) Peru: Curosurf;
  • (PK) Pakistan: Curosurf;
  • (PL) Poland: Curosurf;
  • (PT) Portugal: Curosurf;
  • (RO) Romania: Curosurf;
  • (RU) Russian Federation: Curosurf;
  • (SE) Sweden: Curosurf;
  • (SI) Slovenia: Curosurf;
  • (SK) Slovakia: Curosurf;
  • (TH) Thailand: Curosurf;
  • (TN) Tunisia: Curosurf;
  • (TR) Turkey: Curosurf;
  • (UA) Ukraine: Curosurf;
  • (VE) Venezuela, Bolivarian Republic of: Curosurf;
  • (ZA) South Africa: Curosurf
  1. Aguar M, Cernada M, Brugada M, Gimeno A, Gutierrez A, Vento M. Minimally invasive surfactant therapy with a gastric tube is as effective as the intubation, surfactant, and extubation technique in preterm babies. Acta Paediatr. 2014;103(6):e229-233. [PubMed 24628379]
  2. Amini E, Sheikh M, Shariat M, Dalili H, Azadi N, Nourollahi S. Surfactant administration in preterm neonates using laryngeal mask airway: a randomized clinical trial. Acta Med Iran. 2019;57(6):348-354.
  3. Barbosa RF, Simões E Silva AC, Silva YP. A randomized controlled trial of the laryngeal mask airway for surfactant administration in neonates. J Pediatr (Rio J). 2017;93(4):343-350. doi:10.1016/j.jped.2016.08.007 [PubMed 28130967]
  4. Bensouda B, St-Hilaire M, Mandel R, Barbier A, Ali N. Implementation of less-invasive surfactant administration in a Canadian neonatal intensive care unit. Arch Pediatr. 2022;29(6):444-447. doi:10.1016/j.arcped.2022.05.010 [PubMed 35667998]
  5. Curosurf (poractant alfa) intratracheal suspension [prescribing information]. Cary, NC: Chiesi USA Inc; May 2022.
  6. Curosurf (poractant alfa) intratracheal suspension [product monograph]. Brantford, Ontario, Canada: Methapharm Inc; June 2021.
  7. Dargaville PA, Aiyappan A, De Paoli AG, et al. Minimally-invasive surfactant therapy in preterm infants on continuous positive airway pressure. Arch Dis Child Fetal Neonatal Ed. 2013;98(2):F122-126. [PubMed 22684154]
  8. Devi U, Roberts KD, Pandita A. A systematic review of surfactant delivery via laryngeal mask airway, pharyngeal instillation, and aerosolization: methods, limitations, and outcomes. Pediatric Pulmonology. 2022;57:9-19. doi:10.1002/ppul.25698
  9. Göpel W, Kribs A, Ziegler A, et al. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet. 2011;378(9803):1627-1634. [PubMed 21963186]
  10. Guthrie SO, Fort P, Roberts KD. Surfactant administration through laryngeal or supraglottic airways. Neoreviews. 2021;22(10):e673-e688. doi:10.1542/neo.22-10-e673 [PubMed 34599065]
  11. Herting E, Härtel C, Göpel W. Less invasive surfactant administration: best practices and unanswered questions. Curr Opin Pediatr. 2020;32(2):228-234. doi:10.1097/MOP.0000000000000878 [PubMed 32068592]
  12. Kanmaz HG, Erdeve O, Canpolat FE, Mutlu B, Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics. 2013;131(2):e502-509 [PubMed 23359581]
  13. Kribs A, Roll C, Göpel W, et al. Nonintubated surfactant application vs conventional therapy in extremely preterm infants: a randomized clinical trial. JAMA Pediatr. 2015;169(8):723-730. doi:10.1001/jamapediatrics.2015.0504 [PubMed 26053341]
  14. Polin RA, Carlo WA; Committee on Fetus and Newborn; American Academy of Pediatrics. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014;133(1):156-163. doi:10.1542/peds.2013-3443 [PubMed 24379227]
  15. Roberts KD, Brown R, Lampland AL, et al. Laryngeal mask airway for surfactant administration in neonates: a randomized, controlled trial. J Pediatr. 2018;193:40-46.e1. doi:10.1016/j.jpeds.2017.09.068 [PubMed 29174079]
  16. Truong TT, Tran HT, Skinner A, Narchi H. Less invasive surfactant administration by umbilical catheter is safe and effective for treating respiratory distress syndrome in preterm infants. Acta Paediatr. 2023;112(4):706-707. doi:10.1111/apa.16650 [PubMed 36579363]
  17. Zapata HA, Fort P, Roberts KD, Kaluarachchi DC, Guthrie SO. Surfactant administration through laryngeal or supraglottic airways (SALSA): a viable method for low-income and middle-income countries. Front Pediatr. 2022;10:853831. doi:10.3389/fped.2022.853831 [PubMed 35372140]
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