Colfosceril (Surfactant, phospholipids, poractant alfa)

Generic name
Colfosceril (Surfactant, phospholipids, poractant alfa)
Brand name
ATC Code
R07AA02
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Colfosceril (Surfactant, phospholipids, poractant alfa)

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The half-life of surfactant disaturated-phosphatidylcholine (DSPC) was prolonged with a higher dose and after the 2nd administration.

Dose Age T1/2 (surfactant DSPC) 1e administration (mean) (h) T1/2 (surfactant DSPC) 2nd administration (mean) (h) References
100 mg/kg GA 30 weeks, birthweight 1416 g (mean) - 34,2 Torresin 2000, 
100 mg/kg GA 28,9 weeks, birthweight 1110 g (mean)  15 21 Torresin 2000; Cogo 2009
200 mg/kg GA 28,4 weeks, birthweight 1058 g (mean)  32 43 Cogo 2009

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Early rescue treatment of neonatal respiratory distress syndrome (nRDS)
  • Endotracheal
    • Premature infants Gestational age < 37 weeks
      [1] [2] [3] [4] [6] [8] [11] [14]
      • Initial dose: 100 - 200 mg/kg/dose Repeat if needed with 100 mg/kg/dose.
        • Administration through LISA procedure is preferred.
        • A number of studies show that an initial dose of 200 mg/kg/dose may be more effective for administration via LISA/MIST. 
        • Administration only by those who are educated and have experience with the care, resuscitation, and stabilizing of critically ill preterm- and term neonates.
Meconium aspiration syndrome (MAS)
  • Endotracheal
    • Term neonate
      [18] [19] [23] [24]
      • 200 mg/kg/dose Repeat with a dose of 100 mg/kg/dose if needed and when a clinical effect is observed.
        • There is limited evidence for the efficacy of surfactant for this indication
        • Administration only by those who are educated and have experience with the care, resuscitation, and stabilizing of critically ill preterm- and term neonates.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Uncommon (0.1-1%): sepsis, intracranial hemorrhage, pneumothorax.

Rare (0.01-0.1%): bradycardia, hypotension, bronchopulmonary dysplasia, pulmonary hemorrhage, decrease in oxygen saturation.

Further reported: hyperoxia, neonatal cyanosis, apnea, abnormal EEG, endotracheal intubation complication (including endotracheal reflux).

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Pneumonia and sepsis, because it can have a negative effect on the phagocytosis of fat emulsions by macrophages and leukocytes.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Before starting treatment, the general condition of the newborn should be stable. It is recommended to correct any metabolic or respiratory acidosis, hypotension, anemia, hypoglycemia and hypothermia prior to administration.

Thorough tracheal suctioning prior to treatment is necessary to reduce the possibility of obstruction due to mucus accumulation.

Mechanical ventilation should be continued after administration under (preferably) continuous transcutaneous PaO2 measurement. Close monitoring of arterial blood gases, fraction of inhaled oxygen (FiO2) and ventilation pressures during treatment is necessary. Improvement in oxygenation occurs within minutes, requiring adjustment (reduction) of oxygen concentration in ventilation air and ventilation pressures to prevent hyperoxemia, pulmonary overstretching and fatal pulmonary air leakage. In high-frequency ventilation (> 60/min and expiration time < 0.6 s), care must be taken to ensure that the expiration time is long enough. To prevent hyperoxia and disorders of the premature infant's eyes, the arterial oxygen pressure must not rise above the desired values; to this end, adjust the oxygen concentration in the inspiratory air if necessary.

Interrupt treatment in case of: bradycardia, hypotension, reduced oxygen saturation, reflux, severe apnea.

Tracheal suctioning should be avoided as much as possible during the first 6 hours after administration.

In case of inadequate response or rapid relapse, other causes of immaturity, such as patent ductus arteriosus or pneumonia, should be ruled out. At the first signs of infection during treatment, antibiotics should be given.

Newborns with prolonged (> 3 w.) herniation of the membranes, may have pulmonary hypoplasia that does not respond optimally to the exogenous surfactant.

Source: SmPC

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER RESPIRATORY SYSTEM PRODUCTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

  1. Chiesi Pharmaceuticals BV, SmPC Curosurf (RVG 16150) 07-02-2017, www.geneesmiddeleninformatiebank.nl
  2. Sweet DG, et al ., European Consensus Guidelines on the Management of Respiratory Distress Syndrome- 2019 Update, Neonatology, 2019, 115(4), 432-450
  3. Tridente A, et al, Porcine vs bovine surfactant therapy for preterm neonates with RDS: systematic review with biological plausibility and pragmatic meta-analysis of respiratory outcomes. , Respir Res, 2019, Feb 6;20(1), 28
  4. Ng EH, et al, Guidelines for surfactant replacement therapy in neonates., Paediatr Child Health., 2021, Feb 1;26(1), 35-49
  5. Collaborative European Multicenter Study Group, Surfactant replacement therapy for severe neonatal respiratory distress syndrome: an international randomized clinical trial. Collaborative European Multicenter Study Group. . 1988;82(5):683-91, Pediatrics, 1988, 82(5), 683-91
  6. Janssen LC, et al., Minimally invasive surfactant therapy failure: risk factors and outcome., Arch Dis Child Fetal Neonatal Ed. , 2019, 104(6), F636-f42
  7. Niemarkt HJ, et al., National Recommendation Surfactant Administration update 2020, 2020
  8. 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, 21(3), 109-19
  9. Królak-Olejnik B, et al., Dose Effect of Poractant Alfa in Neonatal RDS: Analysis of Combined Data from Three Prospective Studies., Front Pediatr., 2020, 8, 603716
  10. Torresin M, et al., Exogenous surfactant kinetics in infant respiratory distress syndrome: A novel method with stable isotopes. , Am J Respir Crit Care Med., 2000, 161(5), 1584-9
  11. Dargaville PA, et al., Minimally-invasive surfactant therapy in preterm infants on continuous positive airway pressure., Arch Dis Child Fetal Neonatal Ed, 2013, 98(2), F122-6
  12. Robertson B, et al., A 2-year follow up of babies enrolled in a European multicentre trial of porcine surfactant replacement for severe neonatal respiratory distress syndrome. Collaborative European Multicentre Study Group. , Eur J Pediatr., 1992, 151(5), 372-6
  13. Saugstad OD, et al., [Neonatal respiratory distress syndrome treated with a natural surfactant. The Norwegian Curosurf study], Tidsskr Nor Laegeforen, 1993, 113(19), 2389-93
  14. Cogo PE, et al., Dosing of porcine surfactant: effect on kinetics and gas exchange in respiratory distress syndrome., Pediatrics, 2009, 124(5), e950-7
  15. Speer CP, et al., Randomized European multicenter trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf., Pediatrics, 1992, 89(1), 13-20
  16. Balazs G,et al., Incidence, predictors of success and outcome of LISA in very preterm infants., Pediatr Pulmonol, 2022, 57(7), 1751-9
  17. Halliday HL, et al., Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curosurf 4 trial)., Arch Dis Child, 1993, 69(3 Spec No), 276-80
  18. NVK Working group Neonatal Pharmacotherapy, Expert opinion, 7 dec 2023
  19. Chinese Collaborative Study Group for Neonatal Respiratory Diseases., Treatment of severe meconium aspiration syndrome with porcine surfactant: a multicentre, randomized, controlled trial. , Acta Paediatr, 2005, 94(7), 896-902
  20. 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
  21. Dorrepaal CA, et al., Cerebral hemodynamics and oxygenation in preterm infants after low-vs. high-dose surfactant replacement therapy., Biol Neonate., 1993, 64(4), 193-20
  22. Herting E, et al., Intracerebral haemorrhages in surfactant treated neonates with severe respiratory distress syndrome: age at diagnosis, severity and risk factors., Eur J Pediatr., 1994, 153(11), 842-9
  23. Collaborative European Multicenter Study Group, Surfactant replacement therapy for severe neonatal respiratory distress syndrome: an international randomized clinical trial., Pediatrics, 1988, 82(5), 683-91
  24. Arayici S, et al., Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome., J Trop Pediatr., 2019, 65(5), 491-7

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