Source: FDA, National Drug Code (US) Revision Year: 2020
Infasurf is intended for intratracheal use only.
THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING INFASURF, OFTEN RAPIDLY IMPROVES OXY GENATION AND LUNG COMPLIANCE. Following administration of Infasurf, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status. Infasurf therapy is not a substitute for neonatal intensive care. Optimal care of premature infants at risk for RDS and new born infants with RDS who need endotracheal intubation requires an acute care unit organized, staffed, equipped, and experienced with intubation, ventilator management, and general care of these patients.
TRANSIENT EPISODES OF REFLUX OF INFASURF INTO THE ENDOTRACHEAL TUBE, CYANOSIS, BRADYCARDIA, OR AIRWAY OBSTRUCTION HAVE OCCURRED DURING THE DOSING PROCEDURES. These events require stopping Infasurf administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing can proceed with appropriate monitoring.
The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death. The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in Table3.Prophylaxis and treatment study results for each surfactant are combined.
Table 3. Common Complications of Prematurity and RDS in Controlled Trials:
| Complication | Infasurf (N=1001) % | Exosurf Neonatal (N=978) % | Infasurf (N=553) % | Survanta (N=566) % |
|---|---|---|---|---|
| Apnea | 61 | 61 | 76 | 76 |
| Patent ductus arteriosus | 47 | 48 | 45 | 48 |
| Intracranial hemorrhage | 29 | 31 | 36 | 36 |
| Severe intracranial hemorrhagea | 12 | 10 | 9 | 7 |
| IVH and PVLb | 7 | 3 | 5 | 5 |
| Sepsis | 20 | 22 | 28 | 27 |
| Pulmonary air leaks | 12 | 22 | 15 | 15 |
| Pulmonary interstitial emphysema | 7 | 17 | 10 | 10 |
| Pulmonary hemorrhage | 7 | 7 | 7 | 6 |
| Necrotizing enterocolitis | 5 | 5 | 17 | 18 |
a Grade III and IV by the method of Papile.
b Patients with both intraventricular hemorrhage and periventricular leukomalacia.
Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf vs.
Exosurf Neonatal controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal patients.
When repeat dosing was given at fixed 12-hour intervals in the Infasurf vs. Exosurf Neonatal trials, transient episodes of cyanosis, bradycardia, reflux of surfactant into the endotracheal tube, and airway obstruction were observed more frequently among infants in the Infasurf-treated group.
An increased proportion of patients with both intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) was observed in Infasurf-treated infants in the Infasurf-Exosurf Neonatal controlled trials. These observations were not associated with increased mortality.
No data are available on the use of Infasurf in conjunction with experimental therapies of RDS, e.g., high-frequency ventilation. Data from controlled trials on the efficacy of Infasurf are limited to doses of approximately 100 mg phospholipid/kg body weight and up to a total of 4 doses.
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