SURFAXIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SURFAXIN (SURFAXIN).
SURFAXIN (lucinactant) is a synthetic pulmonary surfactant that reduces surface tension at the air-liquid interface in the alveoli, preventing alveolar collapse and improving lung compliance and gas exchange. It contains phospholipids and surfactant protein B analog.
| Metabolism | SURFAXIN is administered intratracheally and acts locally in the lungs. It is not metabolized systemically; the phospholipid components are cleared via macrophage uptake and reutilization. |
| Excretion | Surfaxin (lucinactant) is administered intratracheally and acts locally in the lungs. There is no significant systemic absorption; therefore, excretion pathways are not applicable. The phospholipid components are metabolized and recycled in the lung. |
| Half-life | Not applicable; Surfaxin is not systemically absorbed. Local pulmonary half-life is not clinically relevant. |
| Protein binding | Not applicable; negligible systemic absorption. In vitro, phospholipid constituents may bind to surfactant proteins, but no relevant plasma protein binding. |
| Volume of Distribution | Not applicable; administered directly to the lungs. No systemic distribution. |
| Bioavailability | Intratracheal: 100% locally, with minimal to no systemic absorption. |
| Onset of Action | Intratracheal: Clinical improvement in oxygenation occurs within 1-2 hours of administration. |
| Duration of Action | Intratracheal: Duration of effect is typically 24-48 hours, with repeat doses as needed. Longer duration may require multiple doses. |
Intratracheal administration: 105 mg phospholipids per kg birth weight (1.5 mL/kg of 35 mg/mL suspension) every 12 hours up to 3 doses total.
| Dosage form | SUSPENSION |
| Renal impairment | No dose adjustment recommended as Surfaxin is not systemically absorbed. |
| Liver impairment | No dose adjustment recommended as Surfaxin is not systemically absorbed. |
| Pediatric use | Neonates and infants <1 month: Intratracheal 105 mg phospholipids per kg birth weight (1.5 mL/kg) every 12 hours up to 3 doses. |
| Geriatric use | Not indicated for geriatric population; no data available. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SURFAXIN (SURFAXIN).
| Breastfeeding | SURFAXIN is not systemically absorbed after endotracheal administration; therefore, it is unlikely to be excreted into breast milk. The M/P ratio is not applicable. Use during lactation poses no risk to the nursing infant. |
| Teratogenic Risk | SURFAXIN (beractant) is an exogenous surfactant administered endotracheally to preterm neonates for respiratory distress syndrome. No teratogenic risk applies as it is not administered to pregnant women. Animal reproduction studies are not available; however, based on the drug's indication and route of administration, direct fetal exposure during pregnancy is not anticipated. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to lucinactant or any component of the formulation"]
| Precautions | ["Rapidly acting surfactant: Administer only under controlled clinical settings with immediate access to trained personnel and resuscitation equipment","Risk of endotracheal tube blockage: Monitor for mucus plugs or tube occlusion","Potential for pulmonary hemorrhage: Use caution in infants with patent ductus arteriosus or coagulation disorders","Transient bradycardia or oxygen desaturation during administration"] |
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| Fetal Monitoring | Not applicable for maternal-fetal monitoring as SURFAXIN is administered only to neonates. For the neonatal patient, monitor lung compliance, oxygenation (PaO2, SpO2), ventilation parameters, and for complications such as pulmonary hemorrhage or air leaks. |
| Fertility Effects | No studies on fertility effects in humans or animals have been conducted. Given the drug's localized administration to the lungs and lack of systemic absorption, effects on fertility are unlikely. |