For Healthcare Professionals

Dosing Procedure for Infants1

  • The total dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg) and is divided into 4 quarter-doses, also known as aliquots.
  • Each of the 4 aliquots is given with the infant in a different position to help evenly distribute SURVANTA throughout the lungs.

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 total dose is divided into four quarter-doses, also known as aliquots (4 aliquots = 1 total dose).

4 aliquots of SURVANTA® (beractant) are equal to one total dose

Each aliquot 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

Position 1: Head and body inclined 5 to 10 degrees down, head turned to the right Position 2: Head and body inclined 5 to 10 degrees down, head turned to the left Position 3: Head and body inclined 5 to 10 degrees up, head turned to the right Position 4: Head and body inclined 5 to 10 degrees up, head turned to the left
  • Dosing is performed by one person administering the SURVANTA dose while another gently 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 (ie., 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 aliquot through the catheter over 2-3 seconds.

After administration of the first aliquot, 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 aliquot, 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 aliquot through the catheter over 2-3 seconds. After administration of the first aliquot, 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 aliquot.

Instill the remaining aliquots using the same procedures. After instillation of each aliquot, remove the catheter and ventilate for at least 30 seconds or until the infant is stabilized. After instillation of the final aliquot, 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.

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 aliquot as previously described. After instillation of each aliquot, 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.

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Instructional dosage and administration video for SURVANTA

Instructional dosage and administration video for SURVANTA

SAFETY CONSIDERATIONS1

  • 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.
  • In controlled clinical trials, an increased probability of post-treatment nosocomial sepsis was observed in SURVANTA-treated infants, which was not associated with increased mortality among these infants.

INDICATION AND IMPORTANT SAFETY INFORMATION1

INDICATION

SURVANTA® (beractant) 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.

IMPORTANT SAFETY INFORMATION

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: 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. 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.

Adverse Reactions: The most commonly reported adverse experiences were transient bradycardia and oxygen desaturation; both were associated with the dosing procedure.

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 the table below.

Concurrent event SURVANTA (%) Control (%) P-valuea
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

aP-value comparing groups in controlled studies.

Reference: 1. SURVANTA [package insert].

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