CUROSURF

Poractant alfa is a pulmonary surfactant marketed as Curosurf in the United States and Canada.

It is used to treat Respiratory Distress Syndrome (RDS) in premature infants with an endogenous pulmonary surfactant deficiency.

Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight proteins (surfactant associated proteins SP-B and SP-C).

The phospholipid content of the extract consists primarily of phosphatidylcholine and dipaImitoylphosphatidylcholine.

Poractant alfa is a creamy white suspension of this extract in 0.9% sodium chloride solution.

It contains no preservatives.

Poractant alfa is indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants.

Poractant alfa improved lung compliance, pulmonary gas exchange and survival in preterm rabbits.

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli in the lungs, thus stabilizing them against collapse under transpulmonary pressures.

A deficiency of pulmonary surfactant in premature infants allows surface tension to increase to the point where sections of lung collapse and respiratory distress syndrome (RDS) develops.

Poractant alfa lowers minimum surface tension to less than or equal to 4 mN/m.

This compensates for the lack of endogenous surfactant and restores adequate surface activity to the lungs.

Poractant alfa is administered directly to the site of action in the lungs via endotracheal tube.

It very rapidly adsorbs to the air-liquid interface to form a stable surfactant monolayer.

No studies on absorption of poractant alfa have been performed in humans.

No studies on the distribution of poractant alfa have been performed in humans.

No studies on the metabolism of poractant alfa have been performed in humans.

One small study in rabbits did find that poractant alfa may be degraded by macrophages and that it may, in part, be recycled in the alveoli in a similar manner to endogenous lung surfactant.

No studies on elimination of poractant alfa have been performed in humans.

The half-life of poractant alfa has only been evaluated in animal studies.

When studied in adult and newborn rabbits, the half-life in the lungs was found to be and 67 respectively.

No studies on clearance of poractant alfa have been performed in humans.

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Studies on the carcinogenicity or reproductive effects of poractant alfa have not been conducted.

Mutagenicity assays were negative.

In the case of an overdose with poractant alfa where there are clear clinical effects on the infant's respiration, ventilation, or oxygenation, it is recommended that as much of the solution be aspirated as possible and the infant be managed with supportive measures.

Fluid and electrolyte balances should be monitored closely in this case.

Before administering

CUROSURF, assure proper placement and patency of endotracheal tube Administer intratracheally either in: Two divided aliquots through a 5 French end-hole catheter; or A single bolus through secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation Initial recommended dose is 2.5 mL/kg birth weight Up to two repeat doses of 1.25 mL/kg birth weight may be administered at approximately 12-hour intervals Maximum total dose (initial plus repeat doses) is 5 mL/kg See Full Prescribing Information for instructions on preparation and administration of the CUROSURF suspension 2.1 Important Administration Instructions For intratracheal administration only.

CUROSURF should be administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.

CUROSURF, assure proper placement and patency of the endotracheal tube.

At the discretion of the clinician, the endotracheal tube may be suctioned before administering CUROSURF.

Allow the infant to stabilize before proceeding with dosing.

Administer CUROSURF either

Intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter or Intratracheally in a single bolus through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation. 2.2 Recommended Dosage The initial recommended dose is 2.5 mL/kg birth weight, administered as one or two aliquots depending upon the instillation procedure.

Up to two repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12-hour intervals in infants in whom RDS is considered responsible for their persisting or deteriorating respiratory status.

The maximum recommended total dosage (sum of the initial and up to two repeat doses) is 5 mL/kg. 2.3 Preparation of the CUROSURF Suspension Remove the vial of CUROSURF suspension from a refrigerator at +2°C to +8°C (36°F to 46°F) and slowly warm the vial to room temperature before use.

Visually inspect the

CUROSURF suspension for discoloration prior to administration.

The color of the

CUROSURF suspension should be white to creamy white.

Discard the

CUROSURF vial if the suspension is discolored.

Gently turn the vial upside-down, in order to obtain a uniform suspension.

Locate the notch (FLIP UP) on the colored plastic cap and lift the notch and pull upwards.

Pull the plastic cap with the aluminum portion downwards.

Remove the whole ring by pulling off the aluminum wrapper.

Remove the rubber cap to extract content.

Unopened, unused vials of CUROSURF suspension 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.

Protect from light. 2.4 Administration For endotracheal tube instillation using a 5 French end-hole catheter Slowly withdraw the entire contents of the vial of CUROSURF suspension into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge).

Enter each single-use vial only once.

Attach the 5 French end-hole catheter of appropriate length to position the catheter tip proximal to the distal portion of the endotracheal tube, to the syringe.

Fill the catheter with

CUROSURF suspension.

Discard excess

CUROSURF through the catheter so that only the dose to be given remains in the syringe.

For the first dose: 1.25 mL/kg (birth weight) per aliquot For each repeated dose: 0.625 mL/kg (birth weight) per aliquot First aliquot of CUROSURF suspension: Position the infant in a neutral position (head and body in alignment without inclination), with either the right or left side dependent.

Immediately before

CUROSURF administration, ventilate the infant with supplemental oxygen sufficient to maintain SaO 2 > 92%.

Insert the catheter into the endotracheal tube and instill the first aliquot of CUROSURF suspension.

After the first aliquot is instilled, remove the catheter from the endotracheal tube and manually ventilate with supplemental oxygen until clinically stable.

Second aliquot of CUROSURF suspension

When the infant is stable, reposition the infant such that the other side is dependent.

Administer the remaining aliquot using the same procedures as the first aliquot.

After completion of the dosing procedure, do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur.

For endotracheal tube instillation using the secondary lumen of a dual lumen endotracheal tube Slowly withdraw the entire contents of the vial of CUROSURF suspension into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge).

Do not attach 5 French end-hole catheter.

Remove the needle and discard excess

CUROSURF so that only the dose to be given remains in the syringe.

Keep the infant in a neutral position (head and body in alignment without inclination).

CUROSURF suspension through the proximal end of the secondary lumen of the endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation.

After completion of this dosing procedure, ventilator management may require transient increases in FiO 2, ventilator rate, or PIP.

Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur.

(poractant alfa) intratracheal suspension is a white to creamy white suspension available in sterile, rubber-stoppered clear glass vials containing (one vial per carton): 120 mg/1.5 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension: NDC Number: 10122-510-01 240 mg/3 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension.

Number: 10122-510-03 Store CUROSURF intratracheal suspension in a refrigerator at +2°C to +8°C (36°F to 46°F).

Do not shake.

Vials are for single-dose only.

After opening the vial discard the unused portion.

The safety and effectiveness of

CUROSURF for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) have been established in premature infants and the information on this use is discussed throughout the labeling.

CUROSURF in the treatment of full term infants or older pediatric patients with respiratory failure has not been established.