Curosurf

Not indicated

Dosage Forms & Strengths

intratracheal suspension

• 8mg/mL (1.5mL, 3mL)

Respiratory Distress Syndrome

Prevention: 1.25-2.5 mL/kg once within 15 min of birth; administer additional doses only in infants who continue to require mechanical ventilation and supplemental oxygen

Treatment: 2.5 mL/kg birth weight intratracheal, THEN 1.25 mL/kg q12hr two times PRN (not to exceed 5 mL/kg total); administer additional doses only in infants who continue to require mechanical ventilation and supplemental oxygen

Administration

Instill thru 5 French endhole catheter inserted into (but not beyond distal tip of) ETT

Ensure proper placeent and patancy of the endotracheal tube before administering

May suction endotracheal tube before administering poractant alpha

Each dose instilled as 2 half-doses, with body in different positions to assure adequate distribution

Store vials in fridge, slowly warm to room temp (no artificial warming); invert to mix (no shaking!), discard vial after single use

• ARDS (Acute Respiratory Distress Syndrome)

Exogenous natural pulmonary surfactant preparation; porcine lung extract containing mostly phospholipids.1 3

Respiratory Distress Syndrome (RDS)

Treatment (rescue) of RDS (hyaline membrane disease) in premature neonates (designated an orphan drug by FDA for this use).1 2 6 8

Prevention† of RDS in infants at high risk for RDS.3 7 8

Contraindications

• No known contraindications.1

Warnings/Precautions

Warnings

Use only by clinicians experienced in resuscitation, stabilization, and general care of premature neonates.1

Therapy can rapidly affect oxygenation and lung compliance.1 Perform frequent clinical and laboratory assessments; modify oxygen and ventilatory support in response to respiratory changes.1 2

Transient episodes of decreased oxygen saturation reported.1 If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

Transient episodes of bradycardia and hypotension reported.1 If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

Transient endotracheal tube blockage, reflux of surfactant into endotracheal tube, and airway obstruction reported.1 If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

General Precautions

Correction of acidosis, hypotension, anemia, hypoglycemia, and hypothermia recommended prior to administration.1

Therapy expected to reduce severity of RDS but will not eliminate morbidity and mortality associated with other complications of prematurity (e.g., pneumonia, septicemia, intracranial hemorrhage, patent ductus arteriosus).1

Safety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation) not established.1

Specific Populations

Not intended for use in adults.1

Not intended for use in adults.1

Common Adverse Effects

Transient bradycardia, hypotension, endotracheal tube blockage, decreased oxygen saturation.1

Storage

Intratracheal

2–8° C.1 Protect from light.1

Prior to use, warm to room temperature for up to 24 hours.1

May return unopened, unused vials to refrigerator within 24 hours of warming.1 Do not warm and return to refrigeration more than once.1

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Curosurf (poractant alfa) is an intratracheal suspension available in vials:

• 1.5 mL [120 mg poractant alfa (surfactant extract)], or
• 3 mL [(240 mg poractant alfa (surfactant extract)].

Curosurf is a white to creamy white suspension.  Each mL of suspension contains 80 mg poractant alfa (surfactant extract) that includes 76 mg of phospholipids and 1 mg of protein of which 0.45 mg is SP-B and 0.59 mg is SP-C.

12.1 Mechanism of Action

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in Respiratory Distress Syndrome (RDS) characterized by poor lung expansion, inadequate gas exchange, and a gradual collapse of the lungs (atelectasis).

Curosurf compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.

12.2 Pharmacodynamics

In vitro - Curosurf lowers minimum surface tension to ≤ 4mN/m as measured by the Wilhelmy Balance System.

12.3 Pharmacokinetics

Curosurf is administered directly to the lung, where biophysical effects occur at the alveolar surface. No human pharmacokinetic studies have been performed to characterize the absorption, biotransformation, or elimination of Curosurf.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess potential carcinogenic effects of Curosurf have not been conducted.

Poractant alfa was negative for genotoxicity in the following assays: bacterial reverse mutation assay (Ames test), gene mutation assay in Chinese hamster V79 cells, chromosomal aberration assay in Chinese hamster ovary cells, unscheduled DNA synthesis in HELA S3 cells, and in vivo mouse micronucleus assay.

No studies to assess reproductive effects of Curosurf have been performed.