lucinactant

lucinactant

(loo-sin-act-ant) ,

Surfaxin

(trade name)

Classification

Therapeutic: anti rds agents
Pharmacologic: pulmonary surfactants

Indications

Prevention of Respiratory Distress Syndrome (RDS) in premature infants who are at high risk. Not indicated for (Adult Respiratory Distress Syndrome) ARDS.

Action

Provides replacement pulmonary surfactant; lowers surface tension which stabilizes alveoli from collapse.

Therapeutic effects

↓ incidence of RDS at 24 hr with decreased associated mortality.

Pharmacokinetics

Absorption: Action is local following intratracheal administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (effects on surface tension)

ROUTEONSETPEAKDURATION
Intratrachealunknownunknown up to 6 hr

Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Frequent assessment is necessary; modifications in oxygen/ventilatory support may be required.

Adverse Reactions/Side Effects

Respiratory

  • oxygen desaturation

Cardiovascular

  • bradycardia

Dermatologic

  • pallor

Local

  • reflux into endotracheal tube/endotracheal tube obstruction

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intratracheal (Neonates) 5.8 mL/kg birth weight may be repeated no more frequently than every 6 hr, not to exceed 4 doses in the first 48 hr of life.

Availability

Intratracheal suspension (contains phospholipids): 8.5 mL/vial

Nursing implications

Nursing assessment

  • Monitor respiratory status (lung sounds, oxygen saturation) frequently during therapy.
  • Assess for adverse reactions (bradycardia, oxygen desaturation, reflux of drug into entotracheal tube, airway/endotracheal tube obstruction) frequently during treatment. If these occur, interrupt therapy and assess clinical condition. Suctioning or reintubation may be required. Continue treatment once infant is stable.

Potential Nursing Diagnoses

Ineffective breathing pattern (Indications)
Ineffective airway clearance (Adverse Reactions)

Implementation

  • Intratracheal: Should be administered by clinicians experienced in intubation, ventilator management, and care of premature infants.
    • Up to 4 doses can be administered within the first 48 hrs of life; give no more frequently than every 6 hrs.
    • Warm vial for 15 min in preheated dry block heater set at 44°. After warming, shake vial vigorously until suspension is uniform and free-flowing. Solution should ve opaque white to off-white. Record date and time warmed in space provided on carton. May be stored for up to 2 hrs after warming at room temperature; do not return to refrigerator. Discard is not used within 2 hrs. Vials are single-use.
    • Slowly draw up appropriate amount of lucinactant using a 16 or 18 gauge needle.
    • Assure patency and proper placement of endotracheal tube; may be suctioned before administration. Allow infant to stabilize before administering. Position infant in right lateral decubitus position with head and thorax inclined upward 30°. Attach syringe containing lucinactant to a 5–French end-hole catheter. Thread catheter through a Bodai valve or equivalent device that allows maintenance of positive end-expiratory pressure, then advance tip of catheter into endotracheal tube. Position catheter such that tip is slightly distal to end of endotracheal tube.
    • Each dose is delivered in 4 aliquots. Instill first aliquot (1/4 of total volume) as a bolus while continuing positive pressure mechanical ventilation and maintaining positive end-expiratory pressure of 4 or 5 cm H2O. Adjust ventilator settings to maintain appropriate oxygenation and ventilation. Once infant is stable and oxygen saturation is at least 90% and heart rate is >120 beats per min, repeat procedure with infant in left lateral decubitus position. Repeat procedure with infant in right then left decubitus position for 4 aliquots. Evaluate infant's respiratory status between aliquots.
    • After instillation of last aliquot, remove catheter and resume ventilation. Keep infant's head elevated at least 10° for at least 1–2 hr. Do not suction infant during first hr after dosing unless signs of significant airway obstruction occur.

Patient/Family Teaching

  • Explain purpose of therapy to parents.

Evaluation/Desired Outcomes

  • Decrease in signs of RDS.
References in periodicals archive ?
* Windtree Therapeutics Inc(NASDAQ: WINT) shares climbed 16.94 percent to $1.45 after the company announced that the Data Safety Monitoring Board had completed its second and final interim safety review of AEROSURF(R) (lucinactant for inhalation) and recommended continuing the trial without modification.
The clinical use of Aerosur[R] which is the aerosol form of Lucinactant (Surfaxin[R]), which was produced byMazela et al.
M2 EQUITYBITES-October 7, 2013-Discovery Laboratories Inc wins FDA approval for updated SURFAXIN (lucinactant) specifications for prevention of respiratory distress syndrome in premature infants(C)2013 M2 COMMUNICATIONS http://www.m2.com
M2 PHARMA-October 7, 2013-Discovery Laboratories Inc wins FDA approval for updated SURFAXIN (lucinactant) specifications for prevention of respiratory distress syndrome in premature infants(C)2013 M2 COMMUNICATIONS
A new surfactant, lucinactant, as been approved for prevention of respiratory distress syndrome in premature infants, the fifth surfactant approved in the United States, the Food and Drug Administration announced.
Newer protein analogue artificial surfactants are Surtax in (lucinactant) and Venticute.
The company added that SURFAXIN (lucinactant) is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine.
However, a new synthetic surfactant, Surfaxin (lucinactant) is currently being considered by the FDA.
6 September 2011 - US Discovery Labs Inc (NASDAQ:DSCO) said today that last Friday it submitted its Complete Response to the 2009 Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) for SURFAXIN (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants.
15 October 2010 - US Discovery Laboratories Inc (NASDAQ: DSCO) said today that the Phase IIa study of aerosolised KL4 surfactant (lucinactant) in patients with cystic fibrosis (CF) has been completed.
24 February 2010 - US biotechnology company Discovery Laboratories Inc (NASDAQ: DSCO) said on 16 February that, in response to a written guidance received from the US Food and Drug Administration (FDA), it will now focus on a pathway that would entail solely performing additional preclinical work, instead of conducting a limited clinical trial, to potentially gain FDA marketing approval for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.