Description and indication for use
Poractant Alfa is an exogenous pulmonary Surfactant
extracted from porcine lungs. It decreases surface tension of the lungs,
thereby improving lung expansion and gaseous exchange. Poractant Alfa helps
reduce lung tissue damage. It is used for ventilated infants who are either at
high risk of Respiratory Distress Syndrome (prophylaxis) or are
suffering from Respiratory Distress Syndrome (rescue).
Criteria for Use
Prophylactic: intubated and ventilated babies 30 weeks gestation or less, as soon
as possible after intubation (preferably within 15 minutes).
Babies should not be intubated solely to
administer surfactant.
Rescue: ventilated infants with RDS, who require
more than 40% oxygen to maintain their oxygen saturation between 91% and 95%.
Surfactant
use in circumstances other than the above should be discussed with the
consultant.
Dose
ETT: 200 mg/kg (2.5
mL/kg) bolus4, 11
A
number of studies support higher dosing regimens with an initial dose of 200 mg/kg,
followed by 100 mg/kg as determined by clinical parameters.
Poractant Alfa is packaged in 1.5 mL vials (120 mg).
Whilst we are keen to minimise the opening of additional vials, a large number
of babies could receive a higher dose of Surfactant by administering the Surfactant
that would usually be discarded. The following regimen is recommended.
Weight range
|
Surfactant dose range
|
Initial
Curosurf® volume
|
<600g
|
200 mg/kg
|
2.5 mL/kg
|
600g to 1.2kg
|
200
mg/kg to 100 mg/kg
|
1.5 mL
|
1.2kg to
2.4kg
|
200
mg/kg to 100 mg/kg
|
3 mL
|
2.4kg to
3.6kg
|
150
mg/kg to 100 mg/kg
|
4.5 mL
|
>3.6kg
|
Consider carefully the
indications for Surfactant in this population.
|
Preparation
Poractant Alfa is available in vial sizes 120
mg in 1.5 mL and 240 mg in 3 mL.
Allow Poractant Alfa to reach room
temperature. Artificial warming methods should not be used.
Give undiluted.
DO
NOT SHAKE.
Do not access or re-warm vial more than
twice.
Route and method of administration
To be administered
via endotracheal tube only
Poractant Alfa is administered as a bolus, via the
endotracheal tube, using a syringe containing the appropriate dose of Poractant Alfa, attached to a shortened, 5 French end-hole catheter.6
Side effects
The administration of Poractant Alfa can rapidly affect oxygenation and
lung compliance.
Transient effects:
Bradycardia.
Hypotension.
Endotracheal
tube blockage.
Oxygen desaturation and bradycardia.
Severe effects:
Pneumothorax.
Special considerations
Before administering Poractant Alfa:
Ensure proper placement and patency of the endotracheal tube.
Suction ETT as necessary.
Cardio-respiratory monitoring and pulse oximeter must be in-situ
(minimum requirement)
After administration of Poractant Alfa:
Observe for
chest movement to ensure that Surfactant has reached the lungs.
Adjust oxygen
requirements as needed and ventilation requirements according to oximetry,
tidal volumes and blood gases.
Do not suction ETT for at least 1 hour
after administration unless clinically unavoidable.
Religious Considerations
Jewish Infants
Poractant Alfa can be administered to
Jewish infants for the following reasons:
1) it is life saving.
2) it is inhaled and not ingested.
Muslim Infants
Muslims are allowed to consume medications
which contain pig by-products if they are life saving. Pork derivatives are
prohibited when taken by mouth or in diet but not if they are used for
indications other than food or diet e.g. intratracheal instillation.2,3
Compatibility Information
Poractant
Alfa is not to be diluted or mixed with any other products.
References:
- The Position of Jewish Halacha towards Curosurf (a porcine derived
surfactant). A summary document, Rabbi Mordechai
Halperin M.D. 19th Dec., 2004.
- Use of Animal Surfactant: should we seek consent? R.Adappa, R.Benson, S.Oddie, J.Wylie, ADC 2003; 88(4):351.
- Use of Animal Surfactant: a religious perspective, Murat Yurdakok. Electronic letters to the editor..ADC 2003; 88(4): 351.
- 4.Multicentre randomised trial comparing high and low dose Surfactant regimens
for the treatment of RDS (the Curosurf trial)
Halliday et al. ADC 1993;69: 276-280.
- Guidelines for use of multi-access vials,
RWH pharmacy, K.McMillan, C.Morley, 2003.
- Surfactant Administration. RWH Policy and Procedure Manual 9W-04-2-121.
- MIMS online (www.mimsonline.com.au – accessed
03/10/2013).
- Northern Network Neonatal Formulary, 11th
ed. 2011.