Curosurf

Poractant alfa.

One 1.5 ml vial contains: Active ingredient: phospholipidic fraction from pig lung (poractant alfa) 120mg.
One 3 ml vial contains: Active ingredient: phospholipidic fraction from pig lung (poractant alfa) 240mg.

Pharmacotherapeutic category: Pulmonary surfactant containing natural phospholipids.

Treatment of Respiratory Distress Syndrome (RDS) in pre-term babies. Prophylactic use in premature infants at risk for RDS.

Rescue treatment: The recommended dose is a single dose of 100-200 mg/kg (1.25-2.5 ml/kg) of body weight. It is possible to administer additional doses of 100 mg/kg, each one at about 12-hourly intervals, in infants still requiring assisted ventilation and supplementary oxygen (maximum total dose: 300-400 mg/kg). It is recommended to start treatment as soon as possible after diagnosing RDS.
Prophylaxis: A single dose of 100-200 mg/kg (1.25-2.5 ml/kg) should be administered as soon as possible (within 15 minutes) after birth. Further doses of 100mg/kg can be given 6-12 hours after the first dose, and then at 12 hours intervals in case of occurrence of RDS requiring mechanical ventilation (max. total dose: 300-400 mg/kg).
Method of administration: CUROSURF is available in ready-to-use vials that should be stored in a refrigerator at +2 to +8°C. The vial should be warmed to 37°C before use, and gently turned upside down, without shaking, in order to obtain a homogeneous suspension. The suspension should be withdrawn from the vial by using a sterile needle and syringe.
In order to draw the suspension, carefully follow the instructions as follows: 1) Locate the notch (FLIP UP) on the colored plastic cap.
2) Lift the notch and pull upwards.
3) Pull the plastic cap with the aluminium portion downwards.
4) Remove the whole ring by pulling off the aluminium wrapper.
5) Remove the rubber cap to extract content.
CUROSURF can be administrated either by: A) Disconnecting the infant from the ventilator: Disconnect the infant momentarily from the ventilator and administer 1.25-2.5 ml/kg (100-200 mg/kg) of the suspension, as a single bolus, directly into the lower trachea via the endotracheal tube. Perform approximately one minute of hand-bagging and then reconnect the infant to the ventilator at the same settings as before administration.
Further doses (1.25 ml/kg equivalent to 100 mg/kg) that may be required can be administered in the same manner.
B) Without disconnecting the infant from the ventilator: Administer 1.25 - 2.5 ml/kg (100-200 mg/kg) of the suspension, as a single bolus, directly into the lower trachea by passing a catheter through the suction port and into the endotracheal tube. Further doses (1.25 ml/kg equivalent to 100 mg/kg) that may be required can be administered in the same manner.
C) Intubation Surfactant Extubation (INSURE): Intubate the neonate for the sole purpose of administering the surfactant. Doses are the same indicated at points A) and B).
In this case the neonate is ventilated manually and after administration of the surfactant and extubation, nasal CPAP (Continuous Positive Airway Pressure) may be performed.
D) Less Invasive Surfactant Administration with a thin catheter (LISA): Alternatively, in spontaneously breathing preterm new-borns CUROSURF can also be administered through the Less Invasive Surfactant Administration (LISA) technique using a thin catheter. Doses are the same indicated at points A), B) and C).
A small diameter catheter is placed into the trachea of infants on CPAP, ensuring continuous spontaneous breathing, with direct visualisation of the vocal cords by laryngoscopy. CUROSURF is instilled by a single bolus over 0.5-3 minutes. After CUROSURF instillation, the catheter is immediately removed. CPAP treatment should be continued during the whole procedure.
It is recommended to frequently control blood gases whatever administration is used, as, after administration, an immediate increase of PaO₂ or oxygen saturation is generally observed. It is however advisable to continuously monitor transcutaneous PO₂ or oxygen saturation to avoid hyperoxia.

There have been no reports of overdosage following the administration of CUROSURF. However, in the unlikely event of accidental overdose, and only if there are clear clinical effects on the infant's respiration, ventilation or oxygenation, as much of the suspension as possible should be aspirated and the baby should be managed with supportive treatment, with particular attention to fluid and electrolyte balance.

Hypersensitivity to the active substance or to any of the excipients.
No specific contraindications are known yet.

Babies born following very prolonged rupture of the membranes (higher than 3 weeks) may not show optimal response to the exogenous surfactant. Surfactant administration can be expected to reduce the severity of RDS or the risk of its occurrence, but cannot be expected to completely eliminate mortality and morbidity associated with preterm birth, as preterm babies may be exposed to other complications due to their immaturity. The administration of CUROSURF to premature infants with renal or hepatic impairment has not been studied.

CUROSURF should only be administered in hospital, by those trained and experienced in the care and resuscitation of preterm infants, having available suitable equipment for ventilation and monitoring of babies with RDS. The baby general conditions should be stabilised. Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is also recommended.

Treatment with CUROSURF may cause: Uncommon undesirable effects (affecting less than 1 in 100 people): severe infection (sepsis); bleeding inside the skull (intracranial); presence of air in the pleura (pneumothorax).
Rare undesirable effects (affecting less than 1 in 1000 people): low blood pressure (hypotension), reduced heart rate (bradycardia); chronic lung disease (bronchopulmonary dysplasia); pulmonary haemorrhage; reduced oxygen in blood (reduced oxygen saturation).
Unknown undesirable effects (their frequency cannot be estimated from available data): Difficulty in breathing with respiratory pauses (apnoea); oxygen poisoning (hyperoxia); bluish discoloration of skin and mucous membranes (neonatal cyanosis); abnormal electroencephalogram; complications due to endotracheal intubation.
Some cases of patent ductus arteriosus have been reported in new-borns treated with CUROSURF.
Some moderate and transient adverse events such as bradycardia, apnoea, reduced oxygen saturation, froth at the mouth, coughing, choking and sneezing were observed during the administration of CUROSURF with a thin catheter.
Do not use beyond the expiry date reported on the packaging materials.
Reporting undesirable effects: If the patient experiences any undesirable effects, including those not listed in this monograph, ask the doctor or pharmacist.

Not known.

Do not use any residual quantity in the vial after the 1st aspiration.
Unopened, unused vials of Curosurf that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use.
Do not warm to room temperature and return to refrigerated storage more than once.

The product must be stored at +2 to +8°C in the original package in order to protect from light.

Other Drugs Acting on the Respiratory System

R07AA02 - natural phospholipids ; Belongs to the class of lung surfactants. Used in the treatment of respiratory diseases.

P₁S₁S₃