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Drug dosage identifier

Poractant Alpha

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Dose and administration

Curosurf (Poractant Alfa) 2.5ml/kg (200mg/kg phospholipid) via endotracheal tube, administered by a doctor/NS-ANP.1,2

  • Inject as a single bolus directly into ETT (ensure ETT position is not too deep prior).
  • Baby is supine and flat throughout.
  • Administer as quickly as the baby tolerates.

Can be administered by LISA technique in babies expectantly managed on CPAP support.3

Subsequent doses can be given between 6 to 12 hours after the preceding dose. The second and subsequent doses should be 1.25 ml/kg (100 mg/kg phospholipid).The usual criteria for administering a second dose are:

  • Need for positive pressure ventilation, and
  • FiO2 >0.30

Some infants may require more than 2 doses. This should only be on the instruction of a specialist (SMO).

Indications

  1. Respiratory Distress Syndrome in preterm infants.
  2. Other conditions with presumed surfactant deficiency (discuss with SMO first).
  3. Can be considered in severe Meconium Aspiration Syndrome to reduce the requirement for ECMO.4 Trials used surfactant 100-200mg/kg every 6 hours to a maximum of 4 doses.

Contraindications and precautions

Efficacy of surfactant in the treatment of Group B Streptococcal Pneumonia has not been proven.

Clinical pharmacology

A natural porcine surfactant derived from minced pig lungs. Surfactant is extracted using chloroform or methanol and then purified using liquid-gel chromatography. It is then sterilised via a high pressure filter system and then finally suspended in an isotonic saline solution to a final concentration of 80mg/ml phospholipids. It also contains surfactant apoproteins SP-B and SP-C.5

Poractant increases the degree of mechanical stability of the alveoli and reduces surface tension. A surfactant monolayer is formed at the air-liquid interface, allowing all areas of lung to expand and contract.

Poractant is absorbed extremely rapidly. Infants typically show a rapid improvement in oxygenation within minutes of the dose.

Possible adverse effects

  1. Instability during administration.
  2. Possible ETT blockage.
  3. Rapid changes in lung compliance and blood gases.
  4. Slight increased risk of pulmonary haemorrhage. If this occurs ensure PEEP is increased to 6-8.
  5. Increased risk of nosocomial infections.
  6. Surfactant reflux into the oropharynx may occur following administration using thin catheter technique.

Special considerations

  1. Should be used after consultation with SMO.
  2. Be careful with vial size selection, as inappropriate vial selection may result in high wastage and therefore increased cost.
  3. Monitor O2 saturation, ECG continuously and blood gases and adjust ventilator/oxygen appropriately.
  4. Suction prior to administration if necessary but avoid suctioning if possible for 6 hours following doses.
  5. Jewish and Muslim parents: use in these populations should be discussed with parents. Poractant has been used extensively in Israel and as it is not per se ingested, its use is considered acceptable. Parents should be informed that alternative non-porcine preparations are not immediately available.

Management of Poractant administration

Description

  • Off- white liquid
  • Available in 2 sizes: 1.5ml (120mg phospholipid) and 3ml (240mg phospholipid).

Prescription

Each dose charted as single dose.

Administration

  1. DO NOT SHAKE. Warm vial in hand for 8 minutes or at room temperature for 20 minutes.
  2. Vial should be gently turned upside down before use.
  3. Draw up dose into 3-5ml syringe through a large needle. DO NOT filter.
  4. Doctor/NS-ANP administers surfactant directly into ETT (or in infants on CPAP via a thin catheter see below).
  5. Consider setting ventilation on VG which will automatically drop the PIP as the lung compliance changes.
  6. Avoid suctioning for 6 hours if possible. Subsequent suctioning should be as per baby's normal routine and/or on consultation with medical staff.

Thin catheter administration: LISA technique6,7

For infants currently on CPAP support who are expected to remain on CPAP. Use a 16g angiocatheter (needle removed) marked with a piece of tape where it should sit at the lips to allow the tip to be 1 cm past the cords and gently curve the catheter to assist insertion. Connect a syringe and IV extension tubing prefilled with surfactant preparation. While the infant is breathing via nasal CPAP, introduce laryngoscope and insert catheter up to the mark on the catheter. If difficult to get a good view CPAP prongs can be removed briefly. Secure catheter position and remove laryngoscope. Replace CPAP nasal prongs if they had been removed. Connect prefilled syringe and extension tubing to the catheter. With the infant's mouth closed, instil surfactant during 30 to 120 seconds by mini-boluses, as the baby takes breaths in. There may be some refluxing of surfactant into the oropharynx. In cases of apnoea or bradycardia, perform positive pressure ventilation until recovery. The maximum number of catheterisation attempts should be 3, after which the procedure should be abandoned. The next step would be to intubate using sedation and extubate back to CPAP as soon as possible.

MIST set up

Nursing considerations

  1. Swaddle baby and use sucrose prior to procedure.
  2. Monitor heart rate, SaO2, colour, chest movement and document.
  3. After administration, monitor closely to prevent post-dose hyperoxia and hypocarbia and titrate oxygen according to saturations.
  4. Monitor blood gas (arterial prefered) as ordered by doctor/NS-ANP.

Storage

  1. Unopened vials - refrigerate at 2-8° C. Protect from light.
  2. Unopened vials that have been rewarmed can be returned to the refrigerator within 24 hours.
  3. Opened vials can be re-used up to 12 hours after the first dose if kept refrigerated.
  4. Vials should not be warmed and then refrigerated more than once.

References

  1. Poractant alpha (Curosurf) product information sheet. Douglas pharmaceuticals.
  2. Poractant alpha (Curosurf): Product monograph. Chiesi Farmaceutiici, Parma, Italy.
  3. European Consensus Guidelines on the management of Respiratory Distress Syndrome 2016 - Update. Sweet DG, Carielli V, Greisen G et al. Neonatology 2017;111(2):107-125
  4. Shahed AIE, Dargaville PA, Ohlsson A, Soll R. Surfactant for meconium aspiration syndrome in term and late preterm infants. The Cochrane database of systematic reviews 2014. CD002054
  5. Halliday HL. History of surfactant from 1980. Biol Neonate 2005;87:317-322
  6. Göpel W, Kribs A, Ziegler A, Laux R, et al. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised controlled trial. Lancet 2011;378:1627-33.
  7. Dargaville PA et al. The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation. BMC Pediatrics 2014; 14:213. 

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Document Control

  • Date last published: 18 December 2018
  • Document type: Drug Dosage Guideline
  • Services responsible: ADHB Pharmacy, Neonatology
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years