Beractant

Pharmacologic Category

Lung Surfactant

Dosing: Pediatric

Respiratory distress treatment: Premature neonates: Limited data available in premature neonates <600 g or >1,750 g:

Prophylactic therapy: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as possible after birth, preferably within 15 minutes; as many as 4 doses may be administered during the first 48 hours of life, no more frequently than 6 hours apart; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]). The need for additional doses is determined by evidence of continuing respiratory distress; if the neonate is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr. Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using CPAP immediately after birth with subsequent selective surfactant administration (AAP [Polin 2014]).

Rescue treatment: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as the diagnosis of RDS is made; may repeat if needed, no more frequently than every 6 hours to a maximum of 4 doses during the first 48 hours of life; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood (AAP [Polin 2014]). The need for additional doses is determined by evidence of continuing respiratory distress or if the neonate is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Use: Labeled Indications

Respiratory distress syndrome: Prevention of respiratory distress syndrome (RDS) in premature neonates with birth weight <1,250 g or with evidence of surfactant deficiency (administer within 15 minutes of birth); treatment of RDS in neonates with x-ray confirmation of RDS and requiring mechanical ventilation (administer within 8 hours of birth).

* See Uses in AHFS Essentials for additional information.

Clinical Practice Guidelines

Respiratory distress syndrome:

AAP, Surfactant-Replacement Therapy for Respiratory Distress in the Preterm and Term Neonate, January 2014

European Association of Perinatal Medicine, Consensus Guidelines for Management of Neonatal Respiratory Distress Syndrome, May 2013

Administration: Pediatric

Specific administration method may vary with ventilation technique.

Endotracheal/Intratracheal: Allow beractant to stand at room temperature for 20 minutes or warm in the hand for at least 8 minutes prior to administration; artificial warming methods should NOT be used. Inspect solution to verify complete mixing of the suspension; do not shake; if settling occurs during storage, gently swirl. Suction infant prior to administration.

Endotracheal: Administration to through endotracheal tube using a 5-French end-hole catheter: The infant should be stable before proceeding with administration. Insert a 5-French end-hole catheter into the infant's endotracheal tube. Administer the dose in four 1 mL/kg aliquots. Each quarter-dose is instilled over 2 to 3 seconds followed by at least 30 seconds of manual ventilation or until stable; each quarter-dose is administered with the infant in a different position; slightly downward inclination with head turned to the right, then repeat with head turned to the left; then slightly upward inclination with head turned to the right, then repeat with head turned to the left. Following administration of one full dose, withhold suctioning for 1 hour unless signs of significant airway obstruction.

Intratracheal: Administration method for spontaneously breathing newborns who do not require endotracheal intubation: Minimally invasive surfactant therapy (MIST): Limited data available: Administration via a thin catheter (2.5- to 5-French) has been suggested as a less invasive method. The catheter is placed between the vocal cords under direct laryngoscopy and the surfactant dose is administered over 1 to 3 minutes. In some studies, premedication with atropine was used (Kribs 2007).

Storage/Stability

Store intact vials in refrigerator between 2°C and 8°C (35.6°F and 46.4°F); protect from light and store vials in original carton until ready for use. Unopened, unused vials that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming and stored for future use. Do not remove vial from the refrigerator for >24 hours; do not warm and return to refrigerator more than once.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat or prevent lung distress in premature babies.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Trouble breathing

• Slow heartbeat

• Cough

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Contraindications

There are no contraindications listed in the manufacturer's labeling

Warnings/Precautions

Concerns related to adverse effects:

• Mucous plugs: Marked impairment of ventilation during or shortly after dosing may indicate mucous plugging of the endotracheal tube; suctioning all neonates prior to administration may decrease chance of endotracheal tube obstruction. Replace endotracheal tube immediately if obstruction is not removed with suctioning.

• Nosocomial sepsis: There is an increased risk of post-treatment nosocomial sepsis in treated neonates this increased risk was not associated with increased mortality.

• Transient adverse effects: Transient episodes of bradycardia and decreased oxygen saturation may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable. Rales and moist breath sounds may occur; endotracheal suctioning or other remedial action is necessary if clear-cut signs of airway obstruction are present.

Other warnings/precautions:

• Administration: Intended for endotracheal administration only.

• Appropriate use: Use in neonates <600 grams birth weight or >1,750 grams birth weight has not been evaluated.

• Lung oxygenation/lung compliance: Produces rapid improvements in lung oxygenation and compliance that may require frequent adjustments to oxygen delivery and ventilator settings; hyperoxia may occur within minutes of administration.

• Trained personnel: Rapidly affects oxygenation and lung compliance; restrict use to a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature neonates.

* See Cautions in AHFS Essentials for additional information.

Pregnancy Considerations

Beractant is only indicated for use in premature neonates

Breast-Feeding Considerations

Beractant is only indicated for use in premature neonates

Adverse Reactions

Frequency not defined. The following occurred during the dosing procedure:

>10%: Cardiovascular: Bradycardia (transient)

1% to 10%: Respiratory: Oxygen desaturation

<1%, postmarketing, and/or case reports: Apnea, emphysema (pulmonary interstitial), hypercapnia, hypertension, hypotension, increased susceptibility to infection (post-treatment nosocomial sepsis), low blood CO2, obstruction of endotracheal tube, pallor, pneumothorax (including pneumopericardium), vasoconstriction

* See Cautions in AHFS Essentials for additional information.

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Exceptions are discussed in separate monographs. Risk D: Consider therapy modification

Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Risk X: Avoid combination

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Risk C: Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. Risk D: Consider therapy modification

Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Monitoring Parameters

Continuous ECG and arterial or transcutaneous measurement of systemic oxygen and carbon dioxide during administration; arterial blood gases

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intratracheal:

Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intratracheal:

Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• R07AA

Generic Available (US)

No

Pricing: US

Suspension (Survanta Intratracheal)

25 mg/mL 0.9% (per mL): $114.90

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Replaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS) or in neonates at risk of developing RDS. Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces.

Pharmacodynamics/Kinetics

Onset of action: Improved oxygenation: Within minutes

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Pharmacotherapy Pearls

Beractant contains surfactant-associated proteins SP-B and SP-C (<1 mg/mL).

Each mL contains 25 mg phospholipids suspended in 0.9% sodium chloride solution. Contents of 1 mL: 0.5-1.75 mg triglycerides, 1.4-3.5 mg free fatty acids, and <1 mg protein.

Index Terms

Bovine Lung Surfactant; Natural Lung Surfactant

FDA Approval Date

July 01, 1992

References

Findlay RD, Taeusch HW, Walther FJ. Surfactant replacement therapy for meconium aspiration syndrome. Pediatrics. 1996;97(1):48-52.[PubMed 8545223 ]

Kribs A, Pillekamp F, Hünseler C, Vierzig A, Roth B. Early administration of surfactant in spontaneous breathing with nCPAP: feasibility and outcome in extremely premature infants (postmenstrual age ≤27 weeks). Paediatr Anaesth. 2007;17(4):364-369.[PubMed 17359406]

Lotze A, Mitchell BR, Bulas DI, Zola EM, Shalwitz RA, Gunkel JH. Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. Survanta in Term Infants Study Group. J Pediatr. 1998;132(1):40-47.[PubMed 9469998 ]

Polin RA, Carlo WA, Committee on Fetus and Newborn, American Academy of Pediatrics. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014;133(1):156-163.[PubMed 24379227]

Survanta (beractant) [prescribing information]. North Chicago, IL; AbbVie Inc; December 2019.

Last Updated 4/24/20