Version May 2024
Note: Product only available in Canada.
Respiratory distress syndrome (RDS), treatment:
Mechanically ventilated neonates (limited data available in neonates <380 g and >4,460 g): Endotracheal: Administer 5 mL/kg/dose (135 mg phospholipids/kg/dose) as soon as RDS diagnosed; may repeat dose if needed, up to a total of 4 doses within the first 5 days of life. Additional doses should only be provided to patients with evidence of ongoing moderate or severe RDS (Ref). In studies, repeat doses were administered as frequently as every 6 hours for a total of up to 3 doses if the neonate was still intubated and required ≥30% inspired oxygen with radiologic evidence of RDS or a fraction of inspired oxygen (FiO2) increase ≥10% higher than required following the previous dose (Ref). However, guidelines recommend surfactants usually require no more frequent dosing than every 12 hours unless the surfactant is being inactivated by an infectious process, meconium, or blood (Ref).
Spontaneously breathing neonates (minimally invasive surfactant therapy [MIST]/less invasive surfactant application [LISA]): Limited data available: Intratracheal: 5 mL/kg/dose (135 mg phospholipids/kg/dose); dosing based on a retrospective study in neonates with RDS on nasal continuous positive airway pressure therapy (CPAP) and requiring >40% inspired oxygen (n=41); eligible patients ranged in gestational age from 28 to 37 weeks; if additional surfactant doses were required other methods of surfactant delivery were utilized; most patients (85.3%) were able to avoid subsequent intubation and/or mechanical ventilation (Ref).
Note: Product only available in Canada.
Respiratory distress syndrome (RDS), treatment:
Mechanically ventilated neonates (limited data available in neonates <380 g and >4,460 g): Endotracheal: Administer 5 mL/kg/dose (135 mg phospholipids/kg/dose) as soon as RDS diagnosed; may repeat dose if needed, up to a total of 4 doses within the first 5 days of life. Additional doses should only be provided to patients with evidence of ongoing moderate or severe RDS (Ref). In studies, repeat doses were administered as frequently as every 6 hours for a total of up to 3 doses if the neonate was still intubated and required ≥30% inspired oxygen with radiologic evidence of RDS or a fraction of inspired oxygen (FiO2) increase ≥10% higher than required following the previous dose (Ref). However, guidelines recommend surfactants usually require no more frequent dosing than every 12 hours unless the surfactant is being inactivated by an infectious process, meconium, or blood (Ref).
Spontaneously breathing neonates (minimally invasive surfactant therapy [MIST]/less invasive surfactant application [LISA]): Limited data available: Intratracheal: 5 mL/kg/dose (135 mg phospholipids/kg/dose); dosing based on a retrospective study in neonates with RDS on nasal continuous positive airway pressure therapy (CPAP) and requiring >40% inspired oxygen (n=41); eligible patients ranged in gestational age from 28 to 37 weeks; if additional surfactant doses were required other methods of surfactant delivery were utilized; most patients (85.3%) were able to avoid subsequent intubation and/or mechanical ventilation (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in neonates.
>10%:
Cardiovascular: Bradycardia (13%), patent ductus arteriosus (44%)
Infection: Sepsis (28%)
Nervous system: Intraventricular hemorrhage (29%)
Ophthalmic: Retinopathy of prematurity (19%)
Respiratory: Decreased lung function (defined as oxygen saturation decreased or increased CO2) (39%)
1% to 10%:
Cardiovascular: Hypotension (2%)
Endocrine & metabolic: Respiratory acidosis (4%)
Gastrointestinal: Necrotizing enterocolitis (6%)
Hematologic & oncologic: Pulmonary hemorrhage (8%)
Nervous system: Encephalopathy (including periventricular leukomalacia: ≤8%), hydrocephalus (1%), seizure (2%)
Respiratory: Apnea (2%), interstitial pulmonary disease (9%), pneumonia (1%), pneumothorax (8%)
Miscellaneous: Procedural complications (endotracheal intubation: 6%)
<1%:
Cardiovascular: Cardiac abnormality (pulmonary valve stenosis), cardiomegaly, cerebral infarction, hypertension, hypertrophic cardiomyopathy, supraventricular tachycardia
Dermatologic: Cellulitis
Endocrine & metabolic: Acidosis, growth retardation, hypercalcemia, hyperkalemia, hypoglycemia
Gastrointestinal: Enteritis, gastroesophageal reflux disease, gastrointestinal hemorrhage, intestinal obstruction, intestinal perforation (including pneumoperitoneum)
Genitourinary: Anuria, ureteral disease (hydroureter)
Hematologic & oncologic: Disorder of hemostatic components of blood (neonatal), hemorrhage, thrombocytopenia
Hepatic: Hepatomegaly, neonatal jaundice
Infection: Infection
Local: Local inflammation (ependymitis)
Nervous system: Abnormal electroencephalogram, hypothermia (neonatal), meningitis
Renal: Calcium nephrolithiasis, hydronephrosis
Respiratory: Asphyxia, core pulmonale, hypoxia, pulmonary disease (bronchopulmonary dysplasia), pulmonary edema, pulmonary hypertension
Hypersensitivity to bovine lipid extract surfactant or any component of the formulation; active pulmonary hemorrhage.
Concerns related to adverse effects:
• Mucous plugs: Marked impairment of ventilation during or shortly after dosing may indicate mucous plugs within the endotracheal tube (ETT); suctioning prior to administration may decrease chance of ETT obstruction. Replace ETT immediately if obstruction is not removed with suctioning.
• Sepsis: Therapy may be associated with increased incidence of sepsis; monitor closely for signs/symptoms of sepsis.
• Transient adverse effects: [Canadian Boxed Warning]: Bovine lipid extract surfactant (BLES) may be associated with 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.
Other warnings/precautions:
• Appropriate use: For intratracheal administration only. Correct any acidosis, hypoglycemia, hypothermia, or hypotension prior to administration.
• Monitoring: [Canadian Boxed Warning]: BLES rapidly affects oxygenation and lung compliance; hyperoxia may occur within minutes of administration. Assess oxygenation closely and adjust ventilator and oxygen delivery as necessary to decrease risk of retinopathy of prematurity, overdistension of chest expansion and pulmonary air leaks.
• Trained personnel: [Canadian Boxed Warning]: Restrict use of BLES to a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management and general care of premature infants.
Not available in the US
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intratracheal:
BLES: 27 mg/mL (3 mL, 4 mL, 5 mL)
Specific administration method may vary with ventilation technique.
Endotracheal: For endotracheal administration only. Warm to at least room temperature, but no higher than body temperature prior to administration; see product labeling for detailed instructions. Once at room temperature, gently invert vial (do not shake). Inspect solution to verify complete mixing of the suspension; it is normal for warmed vial to have even dispersion of fine visible flecks; contents should appear off-white to light yellow suspension. Do not filter dose. Suction infant prior to administration. Do not instill bovine lipid extract surfactant down the right mainstem bronchus.
Mechanically ventilated neonates: Endotracheal: After proper placement of endotracheal tube (ETT) has been established and patient is stable following suctioning, insert a 5 French feeding tube in the ETT; see product labeling for detailed instructions. Administer as a single bolus dose or administer dose in up to 3 aliquots as tolerated with neonate in supine position for each aliquot. Each dose or aliquot is instilled over 2 to 3 seconds followed by at least 30 seconds of manual ventilation. Allow 1 to 2 minute recovery periods after each aliquot; oxygen saturation should be ~95% before administration of next aliquot. Avoid administering as a slow drip or in small aliquots as this may lead to poor distribution and uneven lung compliance. If surfactant is slow to subside in the ETT during administration, interrupt administration and hand ventilate until the ETT is cleared before continuing; consider the possibility of a mucous plug if surfactant fails to subside. Following administration of full dose, withhold suctioning for 2 hours unless clinically necessary.
Spontaneously breathing neonates (minimally invasive surfactant therapy [MIST]/less invasive surfactant application [LISA]): Intratracheal: Limited data available: Administration via a thin catheter has been suggested as a less invasive method. The ideal size and type of catheter has not been determined, but studies have used catheters ranging from 2.5 to 5 French (Ref). 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 (Ref).
Store vials frozen at -10°C (14°F) for 36 months. Two excursions at 2°C to 8°C (36°F to 46°F) are permitted for a combined maximum of 2 weeks, and then may return vials to freezer until packaging expiration date. Alternatively, vials may be stored at 2°C to 8°C (36°F to 46°F) for up to 10 months and then discarded. Vials originally stored under refrigeration should not be returned to freezer. Unopened vials kept at room temperature for <6 hours may be returned to original storage conditions (ie, freezer or refrigerator) up to maximum of 2 times. On the vial labeling, record the number of times a vial has been warmed and returned to storage.
Canadian labeling: Treatment of neonatal respiratory distress syndrome.
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
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. Risk D: Consider therapy modification
Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination
Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification
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
Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification
Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Bovine lipid extract surfactant is only indicated for use in premature infants.
Continuous heart rate and transcutaneous O2 saturation should be monitored during administration; frequent arterial blood gas sampling is necessary to prevent postdosing hyperoxia and hypocarbia.
Replaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS). Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces.
Onset of action: 5 to 30 minutes; significant improvement in gas exchange and lung compliance observed within 4 hours
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