Infasurf intratracheal suspension
Name: Infasurf intratracheal suspension
Indications and Usage
Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment ("rescue") of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.
Prophylaxis
Prophylaxis therapy at birth with Infasurf is indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.
Treatment
Infasurf therapy is indicated for infants </=72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.
Precautions
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis studies and animal reproduction studies have not been performed with Infasurf. A single mutagenicity study (Ames assay) was negative.
Adverse Reactions
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 Table 3. Prophylaxis and treatment study results for each surfactant are combined.
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Follow-up Evaluations
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.
How Supplied
Infasurf (calfactant) Intratracheal Suspension is supplied sterile in single-use, rubber-stoppered glass vials containing 3 mL (NDC 0456-4600-03) and 6 mL (NDC 0456-4600-06) off-white suspension.
Store Infasurf (calfactant) Intratracheal Suspension at refrigerated temperature 2° to 8°C (36° to 46°F) and protect from light. THE 3mL VIAL MUST BE STORED UPRIGHT. Vials are for single use only. After opening, discard unused drug.
Rx only
Manufactured for:
FOREST PHARMACEUTICALS, INC.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045
by:
ONY, Inc.
Amherst, NY 14228
RMC 235 Rev. 06/03
PRODUCT PHOTO(S):
NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.