Infasurf

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.

Table 3 : Common Complications of Prematurity and RDS in Controlled Trials

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.

There have been no reports of overdosage with Infasurf. While there are no known adverse effects of excess lung surfactant, overdosage would result in overloading the lungs with an isotonic solution. Ventilation should be supported until clearance of the liquid is accomplished.

>10%

Cyanosis (65%)

Airway obstruction (39%)

Bradycardia (34%)

Reflux into ETT (21%)

Requirement for manual ventilation (16%)

1-10%

Reintubation (3%)

Cautions

Infant may exhibit bradycardia, reflux, cyanosis, airway obstruction, ETT dislodge, hypoventilation

Do not chill & thaw more than once; single-use vials; keep 3 mL vial upright

To best participate in the care of your baby while he or she is in the NICU, carefully follow all instructions provided by your baby's caregivers.

Since calfactant is given as needed by a healthcare professional, it is not likely that your baby will miss a dose.

Since calfactant is given as needed by a healthcare professional, it is not likely that your baby will miss a dose.

• It is used to treat or prevent lung distress in premature babies.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if your child has any side effects that bother your child or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your child's doctor, nurse, or pharmacist about how to store it.