Beractant

Mechanism-of-action class: Surfactant Activity.

• SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.

• Nonecontraindicated

Important Administration Instructions For intratracheal administration only. SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. The administration of SURVANTA is facilitated if one person administers the dose while another person positions and monitors the infant. Before administering SURVANTA, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA. The infant should be allowed to stabilize before proceeding with dosing. Administer SURVANTA intratracheally by instillation through a 5 French end-hole catheter. Recommended Dosage Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). In the prevention strategy, in premature infants with evidence of surfactant deficiency, give the first dose of SURVANTA as soon as possible, preferably within 15 minutes of birth. To treat infants with RDS confirmed by radiographic and clinical findings, give the first dose of SURVANTA as soon as possible, preferably by 8 hours of age. Four doses of SURVANTA can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours. The need for additional doses of SURVANTA is determined by evidence of continuing respiratory distress. Radiographic confirmation of RDS should be obtained before administering additional doses to those who received a prevention dose.

SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.

The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses . Oxygen desaturation occurred with 9.8% of doses . Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment. The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 3. Table 3. All Controlled Studies Concurrent Event SURVANTA (%) Control (%) P -Value a Patent ductus arteriosus 46.9 47.1 0.814 Intracranial hemorrhage 48.1 45.2 0.241 Severe intracranial hemorrhage 24.1 23.3 0.693 Pulmonary air leaks 10.9 24.7 < 0.001 Pulmonary interstitial emphysema 20.2 38.4 < 0.001 Necrotizing enterocolitis 6.1 5.3 0.427 Apnea 65.4 59.6 0.283 Severe apnea 46.1 42.5 0.114 Post-treatment sepsis 20.7 16.1 0.019 Post-treatment infection 10.2 9.1 0.345 Pulmonary hemorrhage 7.2 5.3 0.166 a P -value comparing groups in controlled studies When all controlled studies were pooled, there was no difference in intracranial hemorrhage.

Overdosage with SURVANTA has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after SURVANTA is given, and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.

• Jul 1, 1991BLABLA020032Abbvie

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Beractant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study
  Recruiting · Interventional · 22 enrolled · Hamad General Hospital
  NCT07514481updated 2026-04-07
• Budesonia + Intratracheal Surfactant in Incidence of Bronchopulmonary Dysplasia
  Unknown · Interventional · 336 enrolled · Coordinación de Investigación en Salud, Mexico
  NCT05534685updated 2022-09-14
• Less Invasive Beractant Administration in Preterm Infants
  Completed · Interventional · 60 enrolled · Hospital General Universitario Gregorio Marañon
  NCT02611284updated 2021-08-27
• Aerosolized Surfactant in Neonatal RDS
  Completed · Phase 1 · Phase 2 · Interventional · 159 enrolled · Sood, Beena G., MD, MS
  NCT02294630updated 2021-08-25
• Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
  Completed · Phase 4 · Interventional · 22 enrolled · Poznan University of Medical Sciences
  NCT01941524updated 2020-03-05
• Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
  Completed · Phase 2 · Phase 3 · Interventional · 617 enrolled · NICHD Neonatal Research Network
  NCT01203358updated 2019-03-22
• Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound
  Unknown · Interventional · 64 enrolled · Zekai Tahir Burak Women's Health Research and Education Hospital
  NCT03655457updated 2018-12-11
• MISurf Versus InSurE. A Comparison of Minimally Invasive Surfactant Application Techniques in Preterm Infants
  Terminated · Phase 2 · Interventional · 4 enrolled · Hamilton Health Sciences Corporation
  NCT01615016updated 2017-08-22
• The Effect of Surfactant Administration on Cerebral Oxygenation
  Suspended · Observational · 40 enrolled · Zekai Tahir Burak Women's Health Research and Education Hospital
  NCT01258517updated 2016-09-05
• Efficacy and Safety of Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates
  Unknown · Phase 2 · Phase 3 · Interventional · 900 enrolled · Ramesh K Agarwal
  NCT02774044updated 2016-05-17

Frequently asked questions

How does Beractant work?

Mechanism-of-action class: Surfactant Activity.

What is Beractant used for?

According to FDA labeling, Beractant carries indications including: SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Beractant?

Beractant is classified as Surfactant, Surfactant Activity, Alveolar Surface Tension Reduction.

What are the brand names for Beractant?

Beractant is marketed under brand names including Survanta.

What are the contraindications for Beractant?

Beractant labeling lists contraindications including: None. Always consult the full prescribing information and a clinician.