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Prescribing Information

Prescribing Information

 
 
 
 

Optimal dosing, better outcomes1

Optimal dosing, better outcomes.1

 

When it comes to optimising treatment for neonatal RDS, adequate dosing of CUROSURF is essential for providing the maximum efficacy of the treatment whilst also promoting the safety and well-being of premature infants.1–4

 

BAPM and the Getting It Right First Time (GIRFT) national report for neonatology recommend minimising mechanical ventilation to reduce adverse outcomes like BPD.2,3 An initial CUROSURF dose of 200 mg/kg may help achieve these goals, as studies indicate it results in better outcomes, such as reduced need for surfactant redosing, decreased mechanical ventilation, and a lower rate of BPD, compared with a 100 mg/kg dose of CUROSURF or other preparations.4–9

 

The European Consensus Guidelines supports this approach by awarding its highest level of recommendation to the use of 200 mg/kg over other preparations at a 100 mg/kg dose.1 Furthermore, CUROSURF provides the highest amount of surfactant within the smallest volume of any licensed surfactants within the UK.10,11 This may improve tolerability and lower the risk of complications, such as reflux, which may contribute to airway obstruction.12

 
 

Clinical studies have not demonstrated that using a lower volume leads to better efficacy or safety based on clinically relevant endpoints.

 
 

Clinical studies have not demonstrated that using a lower volume leads to better efficacy or safety based on clinically relevant endpoints.

 
 

Explore the key data supporting CUROSURF dosing below

Rescue treatment9
 

The recommended starting dose is 100–200mg/kg (1.25-2.5 ml/kg), administered in a single dose as soon as possible after diagnosing RDS.  Additional doses of 100 mg/kg (1.25 ml/kg), each at about 12-hourly intervals, may also be administered if RDS is considered to be the cause of persisting or deteriorating respiratory status of the infants (maximum total dose of 300-400 mg/kg). 

Prophylaxis9
 

A single dose of 100–200 mg/kg should be administered as soon as possible after birth (preferably within 15 minutes). Further doses of 100 mg/kg can be given 6–12 hours after the first dose and then 12 hours later in babies who have persistent signs of RDS and remain ventilator-dependent (maximum total dose of 300–400 mg/kg). 

 
 

Want to learn more?
Explore our educational resources.

 
 

CUROSURF 200 mg/kg reduces the rate of surfactant redosing, respiratory support and BPD, compared with a 100 mg/kg dose13

 

A retrospective, single-centre cohort study of 658 infants ≤32 weeks gestational age compared clinical outcomes before and after switching from a 100 mg/kg to a 200 mg/kg dose of CUROSURF. The study found that the higher 200 mg/kg dose led to a reduction in the need for surfactant redosing, respiratory support, and the subsequent rate of BPD, compared with the 100 mg/kg dose.13

 

CUROSURF 200mg/kg compared with 100 mg/kg resulted in:13

 
Need for redosing:
 

17% vs 47.2% (p<0.001)

Shorter duration of oxygen therapy and MV:
 

315 vs. 339 h, p = 0.018; 37 vs. 118 h,
p = 0.000, respectively

Lower rate of BPD:
 

29.4% vs. 15.7%, p = 0.003, and 18.7% vs. 27.3%, p = 0.024, when comparing the 4 and 6-year periods before and after the switch to the higher dose

 
  • A 200 mg/kg dose, compared with 100 mg/kg, had fewer retreatments (17.0% vs. 47.2%, p < 0.001) and a shorter duration of oxygen therapy and mechanical ventilation (315 vs. 339h, p = 0.018; 37 vs. 118 h, p = 0.000, respectively) 
  • Bronchopulmonary dysplasia (BPD) was significantly lower in the 200 mg/kg dose group, compared with the 100 mg/kg group, when comparing either the 4 and 6‐year periods before and after the dose switch (29.4% vs. 15.7%, p = 0.003, and 18.7% vs. 27.3%, p = 0.024, respectively). 
 

CUROSURF 200 mg/kg improves oxygenation, compared with a 100 mg/kg dose.4,13

 

Oxygenation is crucial for the successful transition from foetal to neonatal life. In healthy, well-breathing infants, SpO2 levels rise from 50–60% in the foetus to 90–95% within the first minutes after birth. This increase is essential to support the elevated metabolic rate associated with adapting to extra-uterine life, including thermoregulation and the effort of breathing.14

CUROSURF supports this transition for infants with RDS or surfactant deficiency, and studies have shown that the 200 mg/kg compared with 100 mg/kg dose results in improved oxygenation values after the first dose.11,13

 

In a study investigating 61 preterm infants with RDS undergoing MV within 24 hours of birth, CUROSURF 200 mg/kg demonstrated a lower oxygen index compared with a dose 100 mg/kg (4.0±1.9 vs 6.9±5.4, respectively (p<0.01).4

 

Oxygenation index after first surfactant dose, mean ±SD

 

A retrospective, single-centre cohort study of 658 infants born at or before 32 weeks gestation compared clinical outcomes before and after increasing the CUROSURF dose from 100 mg/kg to 200 mg/kg. The study found that infants receiving the 200 mg/kg dose had improved SpO2, FiO2, and SFR levels 6 hours after the initial dose compared to those receiving 100 mg/kg.13

 

CUROSURF 200 mg/kg compared with 100 mg/kg demonstrated:13

 
SpO2
 

94 [92–96] vs. 93 [91–95], p = 0.000 

FiO2
 

21 [21–25] vs. 24 [21–30], p = 0.000 

SFR
 

448 [376−457] vs. 384 [303−448], p = 0.000

 
 

CUROSURF 200 mg/kg is associated with a lower risk of CPAP failure, compared with a 100 mg/kg dose.15 

 

CPAP is a straightforward, non-invasive and cost-effective therapy, especially beneficial for preterm neonates with RDS; however, failure of CPAP can have serious consequences, including an increased risk of mortality, intraventricular haemorrhage, and BPD as a result of MV.16

 

In a retrospective cohort study, CUROSURF at a dose of 200 mg/kg, compared with a dose of 100 mg/kg, was associated with a lower rate of CPAP failure within the first 72 hours of life (14% vs 35%, respectively).15 

 

Rate of CPAP failure within the first 72 h of life​

 
 

CUROSURF 200 mg/kg is associated with a need for fewer surfactant doses, compared with a 100 mg/kg dose.4–6

 
Ramanathan study:6
 

In a 20-centre prospective, randomised, masked comparison trial of 293 preterm infants, 70 infants (73%) were successfully treated with a single dose of CUROSURF 200 mg/kg compared with 58 (59%) in the CUROSURF 100 mg/kg group and 50 (51%) in the beractant 100 mg/kg group (p<0.002)

Cloete study:5
 

In a retrospective review of respiratory outcomes of neonates receiving treatment with surfactant over a 3-year period, significantly more infants in the CUROSURF 100 mg/kg group (n=118) received >1 dose of surfactant compared with the 200 mg/kg group (n=138). 

Cogo study:4
 

In a study of 61 preterm infants with RDS undergoing MV, 70% of patients who initially received CUROSURF 100 mg/kg received >1 dose, compared with 28.6% of patients who received CUROSURF 200 mg/kg (p<0.01)

 

A side-by-side comparison of these studies cannot be made, as they were not designed to be compared with one another.

 
 

Abbreviations

 

BPD, bronchopulmonary dysplasia; CPAP, continuous positive airway pressure; FiO2, fraction of inspired oxygen; MV, mechanical ventilation; RDS, respiratory distress syndrome; SFR, saturation of oxygen to fraction of inspired oxygen ratio; SpO2 oxygen saturation. 

 
 

References

  1. Sweet DG, et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3–23. 
  2. Getting it right first time: Neonatology national report. Available at  https://gettingitrightfirsttime.co.uk/medical_specialties/neonatology/. Accessed December 2024. 
  3. BAPM toolkit. Reducing the incidence of BPD. Available at https://www.bapm.org/resources/BPD-Toolkit.  Accessed December 2024. 
  4. Cogo PE, et al. Dosing of Porcine Surfactant: Effect on Kinetics and Gas Exchange in Respiratory Distress Syndrome. Pediatrics 2009;124(5):e950–e957. 
  5. Cloete E, et al. Respiratory outcomes following 100 mg/kg v. 200 mg/kg of poractant alpha: A retrospective review. South African Journal of Child Health 2013;7(4):148–152. 
  6. Ramanathan R, et al. A randomized, multicenter masked comparison trial of poractant alfa (CUROSURF) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Am J Perinatol. 2004 Apr;21(3):109–119. 
  7. Singh N, et al. Comparison of animal-derived surfactants for the prevention and treatment of respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2015;12:CD010249. 
  8. Janssen LC, et al. Minimally invasive surfactant therapy failure: risk factors and outcome. Arch Dis Child Fetal Neonatal Ed. 2019;104(6):F636–F642. 
  9. Balazs G, et al. Incidence, predictors of success and outcome of LISA in very preterm infants. Pediatr Pulmonol. 2022;57(7):1751–1759. 
  10. Survanta SmPC. Available at https://www.medicines.org.uk/emc/product/834/smpc. Accessed December 2024.
  11. CUROSURF SmPC. Available at https://www.medicines.org.uk/emc/product/6450/smpc. Accessed December 2024. 
  12. Gerdes JS, et al. An open label comparison of calfactant and poractant alfa administration traits and impact on neonatal intensive care unit resources. J Pediatr Pharmacol Ther. 2006;11:92–100. 
  13. Lanciotti L, et al. Respiratory distress syndrome in preterm infants of less than 32 weeks: What difference does giving 100 or 200 mg/kg of exogenous surfactant make? Pediatr Pulmonol. 2022;57(9):2067–2073. 
  14. Lara-Cantón, et al. Oxygen saturation and heart rate in healthy term and late preterm infants with delayed cord clamping. Pediatr Res 2022: https://doi.org/10.1038/s41390-021-01805-y. 
  15. Janssen LC, et al. Minimally invasive surfactant therapy failure: risk factors and outcome. Arch Dis Child Fetal Neonatal Ed. 2019;104(6):F636–F642. 
  16. Sivanandan S and Sankar MJ. CPAP Failure in Neonates: Practice, Experience, and Focus Do Matter!. Indian J Pediatr 2020;87:881–882.
 
 

IE-CUR-2400041 | December 2024

 

Adverse event reporting

For the UK: Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.

For Ireland: Adverse events should be reported to HPRA Pharmacovigilance – www.hpra.ie. Adverse events should also be reported to Chiesi Limited on 1800 817459 (IE) or PV.UK@Chiesi.com.