Lucinactant

What is Lucinactant?

• Lucinactant (SURFAXIN) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only.

What are the uses of this medicine?

• SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.

How does this medicine work?

• Endogenous pulmonary surfactant lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures.
• A deficiency of pulmonary surfactant in premature infants results in RDS.
• SURFAXIN compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with SURFAXIN.

Is this medicine FDA approved?

• Initial U.S. Approval:2012

How should this medicine be used?

Recommended dosage:

• The recommended dose of SURFAXIN is 5.8 mL per kg birth weight.
• Up to 4 doses of SURFAXIN can be administered in the first 48 hours of life.
• Doses should be given no more frequently than every 6 hours

Administration:

• For intratracheal administration only.
• SURFAXIN should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Intratracheal Suspension: 8.5 mL suspension in a glass vial.

This medicine is available in fallowing brand namesː

• SURFAXIN

What side effects can this medication cause?

The most common side effects of this medicine include:

• endotracheal tube reflux
• pallor
• endotracheal tube obstruction
• need for dose interruption

What special precautions should I follow?

• Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
• Administration-Related Adverse Reactions may occur. If adverse reactions including bradycardia, oxygen desaturation, reflux of SURFAXIN into the endotracheal tube (ETT), and airway/ETT obstruction occur during administration of SURFAXIN, dosing should be interrupted and the
• infant’s clinical condition assessed and stabilized. Suctioning of the ETT or reintubation may be required if airway obstruction persists or is severe.
• Adults with ARDS who received lucinactant via segmental bronchoscopic lavage had an increased incidence of death, multi-organ failure, sepsis, anoxic encephalopathy, renal failure, hypoxia, pneumothorax, hypotension, and pulmonary embolism. SURFAXIN is not indicated for use in ARDS

What to do in case of emergency/overdose?

• There have been no reports of overdose following the administration of SURFAXIN.

Treatment of overdosage:

• If respiration, ventilation, or oxygenation is clearly affected after an accidental overdose, aspirate as much of the suspension as possible and provide the infant with supportive treatment.

Can this medicine be used in pregnancy?

• SURFAXIN should not be used during pregnancy.

Can this medicine be used in children?

• It can be used up to two years of age and is specified for children who are diagnosed with acute respiratory failure following exposure to a pathogen such as RSV or influenza, including H1N1.

Who manufactures and distributes this medicine?

• Manufactured by Discovery Laboratories, Inc.
• Warrington, PA

What should I know about storage and disposal of this medication?

• Store SURFAXIN in a refrigerator at 2° to 8°C (36° to 46°F) and protect from light until ready for use.
• Do not freeze.
• Vials are for single use only.
• Discard any unused portion of SURFAXIN.
• Discard warmed vials of SURFAXIN if not used within 2 hours of warming.

• Dailymed label info on Lucinactant
• FDA Lucinactant

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