Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intratracheal:
Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)
Pharmacology
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.
Pharmacokinetics/Pharmacodynamics
Onset of Action
Improved oxygenation: Within minutes
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).
Contraindications
There are no contraindications listed in the manufacturer's labeling
Dosage and Administration
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.
Storage
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.
Drug Interactions
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. 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. Consider therapy modification
Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Avoid combination
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy
Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. 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. Monitor therapy
Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. Consider therapy modification
Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy
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
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.
Monitoring Parameters
Continuous ECG and arterial or transcutaneous measurement of systemic oxygen and carbon dioxide during administration; arterial blood gases
Pregnancy
Pregnancy Considerations
Beractant is only indicated for use in premature neonates
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber difficulty breathing, slow heartbeat, or cough (HCAHPS).
- Educate caregiver about signs of a significant reaction (eg, 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. Caregiver should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
