Dosing & Uses
Not indicated for adults
Increased serious adverse reactions in adults with acute respiratory distress syndrome (ARDS), see Cautions
Dosage Forms & Strengths
- Each mL contains 30mg phospholipids (22.5mg dipalmitoylphophatidylcholine and 7.5mg palmitoyloleoyl-phosphatidylglyerol, sodium salt), 4.05mg palmitic acid, and 0.862mg sinapultide
Respiratory Distress Syndrome
Indicated for prevention of respiratory distress syndrome (RDS) in premature newborns at high risk for RDS
5.8 mL/kg (birth weight) administered by intratracheal administration; divide dose into 4 aliquots to administer (see Administration)
May administer up to 4 doses in the first 48 hr of life; doses should be administered at least 6 hr apart
Visually inspect before use
After being warmed and vigorously shaken, suspension should be free-flowing and opaque white to off-white
Use aseptic technique to slowly draw up the appropriate amount into a single, appropriately sized syringe, depending on the total dose volume, using a 16- or 18-gauge needle
Before administration, assure proper placement and patency of the endotracheal tube (ETT)
At the discretion of the clinician, the ETT may be suctioned before administering lucinactant; the infant should be allowed to stabilize before proceeding with dosing
Position the infant in the right lateral decubitus position with head and thorax inclined upward 30°; attach the syringe containing lucinactant to a 5-French end-hole catheter, and then thread the catheter through a Bodai valve or equivalent device that allows maintenance of positive end-expiratory pressure and then advance the tip of the catheter into the endotracheal tube; position the catheter such that its tip is slightly distal to the end of the endotracheal tube
Each dose should be delivered in 4 aliquots; instill the first aliquot of the dose (one-quarter of the total volume) as a bolus while continuing positive pressure mechanical ventilation and maintaining positive end-expiratory pressure of 4-5 cm H2O
Ventilator settings may be adjusted at the discretion of the clinician to maintain appropriate oxygenation and ventilation
Ventilate until the infant is stable, that is, has an oxygen saturation of at least 90% and a heart rate greater than 120 bpm
Repeat the procedure with the infant in the left decubitus position while maintaining adequate positive pressure ventilation, then repeat the procedure with the infant in the right again, and then the left decubitus position again to deliver a total of 4 aliquots
A pause should separate administration of the aliquots to allow for an evaluation of the infant’s respiratory status
After instillation of the last aliquot, remove the catheter and resume usual ventilator management and critical care while keeping the head of the infant’s bed elevated at least 10 degrees for at least 1-2 hr
Do not suction the infant during the first hour after dosing unless signs of significant airway obstruction occur
Use the same technique for additional doses, if indicated
- Before use, warm the vial for 15 minutes in a preheated dry block heater set at 44°C (111°F)
- After warming, shake the vial vigorously until a uniform and free-flowing suspension is formed
- The temperature of the product will be approximately 37°C (99°F) or less after the product is drawn into a syringe for administration
- For each vial that is warmed, record the date and time of warming in the space provided on the carton; if not used immediately after warming, vial can be stored protected from light (ie, in the carton) at room temperature for up to 2 hr
- Do not return vial to the refrigerator after warming
- Discard the product if not used within 2 hr of warming
- Vials are for single use only; discard any unused portion of lucinactant
ETT refulx (18%)
Dose interruption (9%)
ETT obstruction (6%)
For intratracheal use only
Frequent clinical assessments for acute changes in lung compliance required; modify oxygen and ventilatory support to respond to changes in respiratory status
During administration, if bradycardia, oxygen desaturation, endotracheal tube (ETT) reflux, or airway/ETT obstruction occurs, administration should be interrupted and the infant’s clinical condition assessed and stabilized; ETT suctioning or reintubation may be required if airway obstruction persists or is severe
Not indicated for use in adults for acute respiratory distress syndrome (ARDS); 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
Mechanism of Action
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; deficiency of pulmonary surfactant in premature infants results in RDS
Lucinactant compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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