Curosurf

Neofax  2017

 

Curosurf      (Poractant  alfa)

 

Dosis

  • Dosis inicial  :  2.5 mL/kg per dose intratracheally, divided into 2 half-dose aliquots

  • Seguida por hasta 2 dosis posteriores de 1.25 mL/kg /dosis administrada cada 12 horas si se requiere [1]

  • Administrar no más frecuentemente que cada 12 horas, a menos que el surfactante es is being inactivated by an infectious process, meconium, or blood [2] .

  • For rescue therapy, administer as soon as possible, preferably within 2 hours after birth.

  • For prophylactic therapy, administer after initial resuscitation but within 10 to 30 minutes after birth [2] .


Administracion

  • For Endotracheal Tube Instillation Using a 5-French end-hole Catheter

    • Clear the trachea of secretions. Shorten a 5F end-hole catheter to 8 cm so the tip of the catheter will protrude just beyond end of ET tube above infant's carina. Slowly withdraw entire contents of vial into a plastic syringe through a large (greater than 20 gauge) needle. Do not filter or shake. Attach shortened catheter to syringe. Fill catheter with surfactant. Discard excess through catheter so only total dose to be given remains in syringe [1] .

    • Infant's ventilator settings should be changed to a rate of 40 to 60 breaths/min, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain oxygen saturation at greater than 92% immediately before administration.

    • Keep infant in the neutral position and briefly disconnect the endotracheal tube from the ventilator and instill the first aliquot (1.25 mL/kg). Infant should be positioned so that either right or left side is dependent for the aliquot.

    • After administration of the aliquot, the dosing catheter is removed from the ET tube and the infant is ventilated for at least 1 minute until stable. Reposition the infant so that the other side is dependent and administer the remaining aliquot with the same procedure [1] .

  • For Endotracheal Tube Instillation Using the Second Lumen of a Dual Lumen Endotracheal Tube

    • Slowly withdraw entire contents of vial into a plastic syringe through a large (greater than 20 gauge) needle.

    • Do not filter or shake.

    • Do not attach a 5 F end-hole catheter.

    • Keep the infant in a neutral position and administer as a single dose through the proximal end of the secondary lumen of the endotracheal tube.

    • Administer dose over 1 minute without interrupting mechanical ventilation [1] .
       

Uses

  • Respiratory distress syndrome (RDS) in premature infants: It is strongly recommended that CPAP immediately after birth with subsequent selective surfactant administration be considered as an alternative to routine intubation with prophylactic or early surfactant administration in preterm infants. Severe RDS in preterm infants born younger than 30 weeks gestation who need mechanical ventilation should be administered surfactant after initial stabilization. Consider the use of rescue surfactant for infants with hypoxic respiratory failure attributable to secondary surfactant deficiency, such as meconium aspiration syndrome or sepsis/pneumonia [2] .

  • Comparative Trials:Animal-derived surfactants (beractant, calfactant, and poractant alfa) had comparable outcomes for air leak syndromes, death, and bronchopulmonary dysplasia in a retrospective study (n=51,282; median birth weight of 1435 g; median gestation age of 30 weeks (27 to 33 weeks)) [3] .

  • Late Administration: Poractant administered at 2 weeks of age in very preterm infants (less than 33 weeks' gestation) on ventilation did not reduce the duration of ventilation; however, the rehospitalization rate for respiratory problems after discharge at 1 year of age was reduced (28.3% vs 51.1%; p=0.03) in a randomized, double-blinded, controlled, multicenter trial (n=118). The dosage of poractant was 2.5 mL/kg (200 mg/kg) [4] .

Neonatal FDA-Approved Indications

  • Indicated for the treatment (rescue) of respiratory distress syndrome in premature infants. Poractant alfa reduced mortality and pneumothoraces associated with RDS [1] .

 

Adverse Effects

  • Transient episodes of reflux of bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation have been reported during administration [1] .

Monitoring

  • Monitor clinical and laboratory tests frequently for appropriate oxygen therapy and ventilatory support [1] .

Pharmacology

  • Pulmonary lung surfactants are essential for effective ventilation by modifying alveolar surface tension thereby stabilizing the alveoli. Curosurf® is a modified porcine-derived minced lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins B and C. Each mL of surfactant contains 80 mg of total phospholipids (54 mg of phosphatidylcholine of which 30.5 mg dipalmitoyl phosphatidylcholine) and 1 mg of protein including 0.3 mg of SP-B [1] .
     

Special Considerations/Preparation

  • Available in 1.5 mL (120 mg phospholipid) and 3 mL (240 mg phospholipid) vials. Refrigerate at 2 to 8 degrees C (36 to 46 degrees F) and protect from light. Inspect Curosurf® for discoloration; normal color is creamy white.

  • If settling occurs during storage, gently turn vial upside-down in order to uniformly suspend.

  • Do not shake.Used vials with residual drug should be discarded.

  • Unopened vials that have been warmed to room temperature one time may be refrigerated within 24 hours and stored for future use.

  • Should not be warmed and returned to the refrigerator more than once [1] .


Referencias

  1. Collaborative European Multicenter Study Group: Surfactant replacement therapy for severe neonatal respiratory distress syndrome: A international randomized clinical trial. Pediatrics 1988;82:683-691.

  2. Bevilacqua G, Parmigiani S, Robertson B: Prophylaxis of respiratory distress syndrome by treatment with modified porcine surfactant at birth: a multicentre prospective randomized trial. J Perinat Med1996;24:609-620.

  3. Egberts J, de Winter JP, Sedin G, et al: Comparison of prophylaxis and rescue treatment with Curosurf® in neonates less than 30 weeks' gestation: A randomized trial. Pediatrics 1993;92:768-774.

  4. Halliday HL, Tarnow-Mordi WO, Corcoran JD, et al: Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curosurf® 4 trials). Arch Dis Child 1993;69:276-280.

  5. Product Information: CUROSURF(R) intratracheal suspension, poractant alfa intratracheal suspension. Dey, Napa, CA, 03/00/2002.

  6. Polin RA: Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics Jan, 2014; 133(1): 156-163.

  7. Trembath A, Hornik CP, Clark R et al: Comparative effectiveness of surfactant preparations in premature infants. J Pediatr Oct, 2013; 163(4): 955-960.

  8. Hascoet JM, Picaud JC, Ligi I et al: Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr Apr1, 2016; 170(4): 365-372.