Survanta

Lung Surfactants

Intratracheal Administration
Beractant is only for intratracheal administration by or under the supervision of clinicians experienced in intubation, ventilator management, and intensive care.
Perform arterial or transcutaneous measurement of systemic oxygen frequently in neonates receiving beractant. Employ measures to avoid hyperoxia.
Prior to administration of beractant it is recommended that metabolic acidosis, anemia, hypoglycemia, hypotension, and hypothermia be corrected.
Beractant is suspended in 0.9% Sodium Chloride Injection, contains no preservatives, and is heat-sterilized. Sodium hydroxide or hydrochloric acid may be added to adjust the pH. The pH is approximately 6.2 to 7.6.
 
Preparation
Beractant does not require reconstitution before use. Do not filter or dilute.
Warm beractant by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. Do not artificially warm before use.
Record the date and time of warming on the vial carton.
Prior to withdrawing a dose, gently swirl to ensure a uniform suspension. Do not shake, this may denature the proteins; avoid excessive foaming. Visible foaming at the surface of the solution are normal.
Use a 20-gauge or larger needle to withdraw the required dose from the vial; do not filter.
Discard any unused portion.
Storage: Unopened, unused vials may be returned to refrigeration within 24 hours of warming. Do not return vials that have been warmed to room temperature after 24 hours or returned more than once. Protect from light.
 
Intratracheal instillation
Carefully follow the detailed dosage and administration instructions in the FDA-approved product label.
At the discretion of the clinician, the endotracheal tube may be suctioned prior to administration.
Administration is via a 5 French end-hole catheter into the endotracheal tube with the tip of the catheter protruding just beyond the end of the endotracheal tube above the infant's carina. Alternatively, beractant can be instilled through the endotracheal tube by using the neonatal suction valve or by briefly disconnecting the endotracheal tube from the ventilator.
Divide the total dose into 4 equal aliquots; administer each aliquot with the neonate in a different position to ensure homogenous distribution throughout the lungs. The product label recommends that 1 person administer the dose while another person positions the neonate.
Between the administration of each aliquot, remove the catheter and ventilate for at least 30 seconds or until stabilized.
Do not suction infant for 1 hour after dosing unless signs of significant airway obstruction occur.
On completion of the dosing procedure, resume usual ventilator management and clinical care.

bradycardia / Rapid / 11.9-11.9
hypocarbia / Rapid / Incidence not known
cyanosis / Early / Incidence not known
apnea / Delayed / Incidence not known
intracranial bleeding / Delayed / Incidence not known

peripheral vasoconstriction / Rapid / 0-1.0
hypertension / Early / 0-1.0
hypotension / Rapid / 0-1.0
hypoxia / Early / Incidence not known
hyperoxia / Rapid / Incidence not known

infection / Delayed / 10.2-10.2
pallor / Early / 0-1.0

Survanta

Rx

Bovine-derived lung surfactant; administered intratracheally; used to prevent and treat neonatal RDS.

4 mL/kg/dose (100 mg of phospholipids/kg/dose) of birth weight intratracheally divided in 4 equal aliquots. May administer up to 3 subsequent doses of 4 mL/kg/dose (100 mg/kg/dose) at 6-hour intervals if needed. Due to the long half-life, the American Academy of Pediatrics (AAP) recommends redosing every 12 hours, unless surfactant is being inactivated by an infectious process, meconium, or blood.[56600] When beractant is administered as prophylaxis, administer subsequent only if RDS is confirmed by radiographic examination. In premature neonates weighing less than 1,250 g birth weight or with evidence of surfactant deficiency, administer beractant as soon as possible, preferably within 15 minutes of birth. To treat neonates with RDS confirmed by X-ray and requiring mechanical ventilation, administer beractant as soon as possible, preferably by 8 hours of age.[44412]

100 mg phospholipids/kg for the initial dose has been suggested; with the dose divided and administered in 4 equal aliquots according to manufacturer administration procedures. Repeat doses may be given as needed according to clinical response every 12 hours. Total dosage has not exceeded 4 doses. One open trial in 59 patients concluded that beractant administration was associated with a improvement in oxygenation vs. controls. Mortality in treated subjects was 18.8% vs. 43.8% for controls in this open label study. The authors recommended that beractant be further studied in ARDS.

†Indicates off-label use

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Amikacin: (Major) Some surfactant antiinfective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. A reduced activity of tobramycin, a commonly nebulized aminoglycoside, has been reported in the presence of surfactant. Use the combination of amikacin and surfactants with caution.
Amphotericin B: (Major) Some surfactant-anti-infective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. Surfactants should not be mixed with anti-infectives that are commonly administered via nebulization such as amphotericin B.
Gentamicin: (Major) Aminoglycosides are commonly given via nebulization to the airway for the prevention and treatment of pneumonia and are known to be at risk for inactivation of their antibiotic activity, mainly due to their susceptibility for changes in pH. A reduced activity of gentamicin may occur in the presence of surfactant.
Neomycin: (Major) Some surfactant antiinfective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation.
Streptomycin: (Moderate) A reduced activity of streptomycin may occur in the presence of surfactant when given via nebulization.
Tobramycin: (Major) Some surfactant anti infective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. A reduced activity of tobramycin, a commonly nebulized aminoglycoside, has been reported in the presence of surfactant.
Vancomycin: (Major) Some surfactant-anti-infective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. Pulmonary surfactants, such as beractant should not be mixed with anti-infectives that are commonly administered via nebulization such as vancomycin.

Survanta Endotracheal Susp: 1mL, 25mg

Safe and effective use has not been established; doses of 100 mg/kg have been reported for off-label use in the treatment of acute respiratory distress syndrome (ARDS).

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

> 1 month: Safety and efficacy have not been established.

100 mg/kg birth weight (4 mL/kg birth weight)/dose intratracheally.

Beractant is administered directly to the lungs and can rapidly restore lung compliance. This composite material is designed to mimic surface-tension lowering properties of natural lung surfactant. This is achieved by reducing the surface tension on alveolar surfaces during respiration and stabilizing alveoli against collapse at resting transpulmonary pressures. A rapid increase in oxygenation may follow treatment; rapid restoration of lung compliance may lead to hyperoxia and hypocarbia. Conversely, hypoxia may occur during therapy, possibly as a result of airway obstruction and oxygen desaturation. Frequent monitoring of arterial blood gases (ABG) is required. Throughout the treatment, ventilation must be maintained to ensure correct oxygenation. An increase in the fraction of inspired oxygen (FiO2) may be necessary during repeat doses to prevent cyanosis.
 
Premature infants are deficient in natural pulmonary surfactant which may reduce surface activity in the lungs and induce respiratory distress syndrome. Restoration of surface tension is achieved by the lipids present in beractant, and rapid spreading and absorption by the proteins. Surfactant therapy in combination with nasal continuous positive airway pressure (CPAP) has been shown to be superior to nasal CPAP alone in a small study of neonates with RDS.
 
Natural human pulmonary surfactant is secreted by the lamellar bodies of alveolar type-II cells, and is first synthesized in the fetus after 24—28 weeks of gestation. Natural human pulmonary surfactant contains a mixture of roughly 90% phospholipids (e.g., phosphatidylcholine and phosphatidylglycerol) and 10% associated surfactant proteins (i.e., SP-A, SP-B, SP-C and SP-D). The exact role of all of the components of natural human pulmonary surfactant is uncertain, and of great scientific interest. Phospholipids adsorb rapidly to the surface of the air:liquid interface of the lung lumen and modify the surface tension within the alveoli. Surfactant-associated proteins, particularly SP-B, appear to be essential in binding, stabilizing, spreading, and recycling phospholipids on the alveolar surfaces. It has been recently discovered that some infants who develop fatal RDS have a genetic deficiency or a genetic mutation of the SP-B protein. Proteins SP-A and SP-D, which are not currently components of exogenous surfactant products, appear to have additional functions relating to host defenses in the lung.

Beractant is administered intratracheally. It is delivered directly to the site of action, and only a small amount reaches the systemic circulation. Distribution is improved by positioning the infant to allow gravity to help distribute surfactant to the distal airways. Clearance is a local phenomenon that involves type II alveolar cells. No information is available about the metabolic fate of the surfactant-associated proteins in the product; metabolic disposition in humans has not been studied.
 
Affected cytochrome P450 isoenzymes: none

Beractant (Survanta) has not been assigned an FDA category for pregnancy risk. Clinical studies in women or in animals during pregnancy are not available. Beractant should only be administered to pregnant women where the potential benefit of the medication would outweigh the unknown risks to the fetus.

There are no data on the use of beractant (Survanta) during lactation. Since data are not available, beractant should be administered with caution during breast-feeding.