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Overview
Beractant is a Lung Surfactant that is FDA approved for the treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. Common adverse reactions include Transient bradycardia, Oxygen desaturation.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications.
Prevention
In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible, preferably within 15 minutes of birth.
Rescue
To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours of age.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Beractant in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Beractant in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications.
Prevention
In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible, preferably within 15 minutes of birth.
Rescue
To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours of age.
Dosage
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.
Marked improvements in oxygenation may occur within minutes of administration of SURVANTA. Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.
Review of audiovisual instructional materials describing dosage and administration procedures is recommended before using SURVANTA. Materials are available upon request from AbbVie Inc.
Dosage
Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). The SURVANTA Dosing Chart shows the total dosage for a range of birth weights.
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.
Directions for Use
SURVANTA should be inspected visually for discoloration prior to administration. The color of SURVANTA is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Some foaming at the surface may occur during handling and is inherent in the nature of the product.
SURVANTA is stored refrigerated (2-8°C). Date and time need to be recorded in the box on front of the carton or vial, whenever SURVANTA is removed from the refrigerator. Before administration, SURVANTA should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. Artificial warming methods should not be used. If a prevention dose is to be given, preparation of SURVANTA should begin before the infant’s birth.
Unopened, unused vials of SURVANTA that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming, and stored for future use. SURVANTA SHOULD NOT BE REMOVED FROM THE REFRIGERATOR FOR MORE THAN 24 HOURS. SURVANTA SHOULD NOT BE WARMED AND RETURNED TO THE REFRIGERATOR MORE THAN ONCE. Each single-use vial of SURVANTA should be entered only once. Used vials with residual drug should be discarded.
SURVANTA does not require reconstitution or sonication before use.
DOSING PROCEDURES
General
SURVANTA is administered intratracheally by instillation through a 5 French end-hole catheter. The catheter can be inserted into the infant’s endotracheal tube without interrupting ventilation by passing the catheter through a neonatal suction valve attached to the endotracheal tube. Alternatively, SURVANTA can be instilled through the catheter by briefly disconnecting the endotracheal tube from the ventilator.
The neonatal suction valve used for administering SURVANTA should be a type that allows entry of the catheter into the endotracheal tube without interrupting ventilation and also maintains a closed airway circuit system by sealing the valve around the catheter.
If the neonatal suction valve is used, the catheter should be rigid enough to pass easily into the endotracheal tube. A very soft and pliable catheter may twist or curl within the neonatal suction valve. The length of the catheter should be shortened so that the tip of the catheter protrudes just beyond the end of the endotracheal tube above the infant’s carina. SURVANTA should not be instilled into a mainstem bronchus.
To ensure homogenous distribution of SURVANTA throughout the lungs, each dose is divided into four quarter-doses.
Each quarter-dose is administered with the infant in a different position. The recommended positions are:
Head and body inclined 5-10° down, head turned to the right
Head and body inclined 5-10° down, head turned to the left
Head and body inclined 5-10° up, head turned to the right
Head and body inclined 5-10° up, head turned to the left
The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant.
First Dose
Determine the total dose of SURVANTA from the SURVANTA dosing chart based on the infant’s birth weight. Slowly withdraw the entire contents of the vial into a plastic syringe through a large-gauge needle (eg, at least 20 gauge). Do not filter SURVANTA and avoid shaking.
Attach the premeasured 5 French end-hole catheter to the syringe. Fill the catheter with SURVANTA. Discard excess SURVANTA through the catheter so that only the total dose to be given remains in the syringe.
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.
In the prevention strategy, weigh, intubate and stabilize the infant. Administer the dose as soon as possible after birth, preferably within 15 minutes. Position the infant appropriately and gently inject the first quarter-dose through the catheter over 2-3 seconds.
After administration of the first quarter-dose, remove the catheter from the endotracheal tube. Manually ventilate with a hand-bag with sufficient oxygen to prevent cyanosis, at a rate of 60 breaths/minute, and sufficient positive pressure to provide adequate air exchange and chest wall excursion.
In the rescue strategy, the first dose should be given as soon as possible after the infant is placed on a ventilator for management of RDS. In the clinical trials, immediately before instilling the first quarter-dose, the infant’s ventilator settings were changed to rate 60/minute, inspiratory time 0.5 second, and FiO2 1.0.
Position the infant appropriately and gently inject the first quarter-dose through the catheter over 2-3 seconds. After administration of the first quarter-dose, remove the catheter from the endotracheal tube and continue mechanical ventilation.
In both strategies, ventilate the infant for at least 30 seconds or until stable. Reposition the infant for instillation of the next quarter-dose.
Instill the remaining quarter-doses using the same procedures. After instillation of each quarter-dose, remove the catheter and ventilate for at least
30 seconds or until the infant is stabilized. After instillation of the final quarter-dose, remove the catheter without flushing it. Do not suction the infant for 1 hour after dosing unless signs of significant airway obstruction occur.
After completion of the dosing procedure, resume usual ventilator management and clinical care.
Repeat Doses
The dosage of SURVANTA for repeat doses is also 100 mg phospholipids/kg and is based on the infant’s birth weight. The infant should not be reweighed for determination of the SURVANTA dosage. Use the SURVANTA Dosing Chart to determine the total dosage.
The need for additional doses of SURVANTA is determined by evidence of continuing respiratory distress. Using the following criteria for redosing, significant reductions in mortality due to RDS were observed in the multiple-dose clinical trials with SURVANTA.
Dose no sooner than 6 hours after the preceding dose if the infant remains intubated and requires at least 30% inspired oxygen to maintain a PaO2 less than or equal to 80 torr.
Radiographic confirmation of RDS should be obtained before administering additional doses to those who received a prevention dose.
Prepare SURVANTA and position the infant for administration of each quarter-dose as previously described. After instillation of each quarter-dose, remove the dosing catheter from the endotracheal tube and ventilate the infant for at least 30 seconds or until stable.
In the clinical studies, ventilator settings used to administer repeat doses were different than those used for the first dose. For repeat doses, the FiO2 was increased by 0.20 or an amount sufficient to prevent cyanosis. The ventilator delivered a rate of 30/minute with an inspiratory time less than
1.0 second. If the infant’s pretreatment rate was 30 or greater, it was left unchanged during SURVANTA instillation.
Manual hand-bag ventilation should not be used to administer repeat doses. During the dosing procedure, ventilator settings may be adjusted at the discretion of the clinician to maintain appropriate oxygenation and ventilation.
After completion of the dosing procedure, resume usual ventilator management and clinical care.
Dosing Precautions
If an infant experiences bradycardia or oxygen desaturation during the dosing procedure, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After the infant has stabilized, resume the dosing procedure.
Rales and moist breath sounds can occur transiently after administration of SURVANTA. Endotracheal suctioning or other remedial action is unnecessary unless clear-cut signs of airway obstruction are present.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Beractant in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Beractant in pediatric patients.
Contraindications
None known.
Warnings
SURVANTA is intended for intratracheal use only.
SURVANTA can rapidly affect oxygenation and lung compliance. 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.
Precautions
General
Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless clear-cut signs of airway obstruction are present.
Increased probability of post-treatment nosocomial sepsis in SURVANTA-treated infants was observed in the controlled clinical trials (Table 3). The increased risk for sepsis among SURVANTA-treated infants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate of post-treatment infections other than sepsis.
Use of SURVANTA in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. There is no controlled experience with use of SURVANTA in conjunction with experimental therapies for RDS (eg, high-frequency ventilation or extracorporeal membrane oxygenation).
No information is available on the effects of doses other than 100 mg phospholipids/kg, more than four doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.
Adverse Reactions
Clinical Trials Experience
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.
When all controlled studies were pooled, there was no difference in intracranial hemorrhage. However, in one of the single-dose rescue studies and one of the multiple-dose prevention studies, the rate of intracranial hemorrhage was significantly higher in SURVANTA patients than control patients (63.3% v 30.8%, P = 0.001; and 48.8% v 34.2%, P = 0.047, respectively). The rate in a Treatment IND involving approximately 8100 infants was lower than in the controlled trials.
In the controlled clinical trials, there was no effect of SURVANTA on results of common laboratory tests: white blood cell count and serum sodium, potassium, bilirubin, and creatinine.
More than 4300 pretreatment and post-treatment serum samples from approximately 1500 patients were tested by Western Blot Immunoassay for antibodies to surfactant-associated proteins SP-B and SP-C. No IgG or IgM antibodies were detected.
Several other complications are known to occur in premature infants. The following conditions were reported in the controlled clinical studies. The rates of the complications were not different in treated and control infants, and none of the complications were attributed to SURVANTA.
Respiratory
lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, respiratory failure.
Follow-Up Evaluations
To date, no long-term complications or sequelae of SURVANTA therapy have been found.
Single-Dose Studies
Six-month adjusted-age follow-up evaluations of 232 infants (115 treated) demonstrated no clinically important differences between treatment groups in pulmonary and neurologic sequelae, incidence or severity of retinopathy of prematurity, rehospitalizations, growth, or allergic manifestations.
Multiple-Dose Studies
Six-month adjusted age follow-up evaluations have been completed in 631 (345 treated) of 916 surviving infants. There were significantly less cerebral palsy and need for supplemental oxygen in SURVANTA infants than controls. Wheezing at the time of examination was significantly more frequent among SURVANTA infants, although there was no difference in bronchodilator therapy.
Final twelve-month follow-up data from the multiple-dose studies are available from 521 (272 treated) of 909 surviving infants. There was significantly less wheezing in SURVANTA infants than controls, in contrast to the six-month results. There was no difference in the incidence of cerebral palsy at twelve months.
Twenty-four month adjusted age evaluations were completed in 429 (226 treated) of 906 surviving infants. There were significantly fewer SURVANTA infants with rhonchi, wheezing, and tachypnea at the time of examination. No other differences were found.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Beractant in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Beractant in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Beractant during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Beractant with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Beractant with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Beractant with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Beractant with respect to specific gender populations.
Race
There is no FDA guidance on the use of Beractant with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Beractant in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Beractant in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Beractant in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Beractant in patients who are immunocompromised.
Administration and Monitoring
Administration
intratracheal
Monitoring
Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.
IV Compatibility
There is limited information regarding IV Compatibility of Beractant in the drug label.
Overdosage
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.
Pharmacology
There is limited information regarding Beractant Pharmacology in the drug label.
There is limited information regarding Pharmacodynamics of Beractant in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Beractant in the drug label.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been performed with SURVANTA. SURVANTA was negative when tested in the Ames test for mutagenicity. Using the maximum feasible dose volume, SURVANTA up to 500 mg phospholipids/kg/day (approximately one-third the premature infant dose based on mg/m2/day) was administered subcutaneously to newborn rats for 5 days. The rats reproduced normally and there were no observable adverse effects in their offspring.
Clinical Studies
There is limited information regarding Clinical Studies of Beractant in the drug label.
How Supplied
Storage
There is limited information regarding Beractant Storage in the drug label.
Images
Drug Images
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