Calfactant

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 in a controlled medical setting by a healthcare professional, an overdose is not likely to occur. However, an overdose of calfactant is not expected to produce life-threatening symptoms.

Follow your doctor's instructions about any restrictions in feeding, medications, or activity after your baby has been treated with calfactant.

Calfactant causes few side effects. There is a possibility that the baby will have breathing difficulties during the calfactant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with calfactant.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Lung Surfactant

Prevention or treatment of RDS in premature infants: Endotracheal administration only: Each dose is 3 mL/kg body weight at birth; should be administered every 12 hours for a total of up to 3 doses

Gentle swirling or agitation of the vial of suspension is often necessary for redispersion. Do not shake. Visible flecks of the suspension and foaming under the surface are normal. Calfactant should be stored upright (3 mL vial) and under refrigeration at 2°C to 8°C (36°F to 46°F); protect from light; document date and time removed from refrigeration. Warming before administration is not necessary. Unopened and unused vials of calfactant that have been warmed to room temperature can be returned to refrigeration storage within 24 hours for future use. Repeated warming to room temperature should be avoided. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.

Applies to calfactant: intratracheal suspension

Data not available

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.

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

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