SURVANTA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SURVANTA (SURVANTA).
Survanta is a natural bovine lung extract containing phospholipids, neutral lipids, and surfactant-associated proteins. It reduces surface tension in the alveoli, preventing alveolar collapse at end-expiration and improving lung compliance.
| Metabolism | Not metabolized; undergoes recycling and clearance by alveolar macrophages and type II pneumocytes. |
| Excretion | primarily pulmonary uptake and catabolism; minimal renal or biliary excretion; elimination via alveolar macrophages and recycling in surfactant |
| Half-life | terminal elimination half-life of approximately 67 hours (range 37-85 hours) due to slow clearance from lungs; clinically, effects persist for days after single dose |
| Protein binding | not applicable (lipoprotein complex consisting of phospholipids and surfactant-associated proteins B and C; does not undergo classical plasma protein binding) |
| Volume of Distribution | not applicable (administered directly into airways; minimal systemic absorption; Vd described as essentially the lung compartment, estimated at 0.01-0.02 L/kg in neonates) |
| Bioavailability | intratracheal: 100% at the site of action (direct delivery to alveoli); systemic bioavailability negligible |
| Onset of Action | intratracheal: within minutes (rapid improvement in oxygenation and lung compliance, typically within 15 minutes) |
| Duration of Action | single dose produces clinical improvement for 24-48 hours; repeated doses may extend effect; duration depends on severity of RDS and rate of surfactant metabolism |
100 mg phospholipids/kg (4 mL/kg) intratracheally, administered as 4 divided aliquots, repeated every 6 hours up to 4 doses as needed.
| Dosage form | SUSPENSION |
| Renal impairment | No specific dose adjustment required based on renal function; suvanta is not systemically absorbed after intratracheal administration. |
| Liver impairment | No specific dose adjustment required based on hepatic function; suvanta is not systemically absorbed after intratracheal administration. |
| Pediatric use | Same as adult dosing: 100 mg phospholipids/kg (4 mL/kg) intratracheally, for neonates and infants with respiratory distress syndrome. |
| Geriatric use | No specific dosing considerations; suvanta is not indicated for geriatric use as it is solely for neonatal respiratory distress syndrome. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SURVANTA (SURVANTA).
| Breastfeeding | No data available on the presence of beractant in human milk, effects on the breastfed infant, or on milk production. Because beractant is administered intratracheally and has negligible systemic absorption, excretion into breast milk is unlikely. Caution is advised if administered to a nursing mother. |
| Teratogenic Risk | Survanta (beractant) is not systemically absorbed after intratracheal administration; therefore, no direct fetal exposure occurs. No teratogenic effects are anticipated. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Use during pregnancy only if clearly needed. |
■ FDA Black Box Warning
Rapidly affects lung compliance and oxygenation; requires experienced clinical personnel and ventilatory support. Risk of pulmonary hemorrhage and off-label use in term infants is not established.
| Serious Effects |
["Known hypersensitivity to bovine-derived products","Pre-existing pulmonary hemorrhage with hemodynamic instability"]
| Precautions | ["Monitor for transient bradycardia, hypotension, or oxygen desaturation during administration","Risk of pulmonary hemorrhage, especially in very low birth weight infants","Requires immediate availability of resuscitation equipment","May increase risk of ventilator-associated pneumonia"] |
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| Fetal Monitoring | Monitor for transient bradycardia, oxygen desaturation, and endotracheal tube reflux during administration. Continuous monitoring of heart rate, oxygen saturation, and ventilation status is required. Fetal monitoring is not applicable as the drug is administered to neonates. |
| Fertility Effects | No studies on fertility effects have been conducted. Beractant is a natural lung surfactant with no known impact on reproductive function or fertility. Systemic absorption is negligible, so effects on fertility are unlikely. |