Infasurf
SIDE EFFECTS
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 t.b. (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 Table 3. Prophylaxis and treatment study results for each surfactant are combined.
Table 3 - Common Complications of Prematurity and RDS in Controlled Trials
| Infasurf | Exosurf Neonatal® | Infasurf | Survanta® | |
| | (N=1001) | (N= 978) | (N=553) | (N= 566) |
| % | % | % | % | |
| Apnea | 61 | 61 | 76 | 76 |
| Patent ductus arteriosus | 47 | 48 | 45 | 48 |
| Intracranial hemorrhage | 29 | 31 | 36 | 36 |
| Severe intracranial hemorrhage a | 12 | 10 | 9 | 7 |
| IVH and PVL b | 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 Combined incidence of intraventricular hemorrhage and periventricular leukomalacia. | ||||
Follow-up Evaluations
Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled at 5 centers that participated in the Infasurf versus Exosurf Neonatal® controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal® patients.
DRUG INTERACTIONS
No infromation provided.
Generic Name: Calfactant
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