FAQ’s

Infasurf® (calfactant) Intratracheal Suspension is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation only. It is an extract of natural surfactant from calf lungs which includes phospholipids, neutral lipids, and hydrophobic surfactant-associated proteins B and C (SP-B and SP-C).

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.

Infasurf® is an off-white suspension.

No, Infasurf® contains no preservatives. Each vial of Infasurf® contains a ratio of approximately 97% saline and 3% Calf Lung Surfactant Extract (CLSE). See the detailed composition of Infasurf® here.

Each dose of Infasurf® is 3 mL/kg body weight at birth.

Infasurf® can be re-dosed every 12 hours or at the discretion of a Medical Doctor.

Infasurf® can be administered every 12 hours for a total of up to 3 doses.

Infasurf® is a suspension which settles during storage. Gentle swirling or agitation of the vial is often necessary for resuspension. DO NOT SHAKE.

Warming of Infasurf® before administration is not necessary.

Repeated warming of Infasurf® to room temperature should be avoided. Unopened, unused vials of Infasurf® that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Infasurf® should not be removed from the refrigerator for more than 24 hours. Infasurf® should not be returned to the refrigerator more than once.

Infasurf® does not require reconstitution. Do not dilute or sonicate.

Vials of Infasurf® are intended for single use. Each single-use vial should be entered only once. Vials with any unused material should be discarded after the initial entry.

Store Infasurf® (calfactant) Intratracheal Suspension upright at refrigerated temperature 2° to 8°C (36° to 46°F) and protect from light. THE 3mL VIAL MUST BE STORED UPRIGHT.

Date and time need to be recorded on the carton when Infasurf® is removed from the refrigerator. Unopened, unused vials of Infasurf® that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Infasurf® should not be removed from the refrigerator for more than 24 hours. Infasurf® should not be returned to the refrigerator more than once. Repeated warming to room temperature should be avoided.

No. Vials of Infasurf® are intended for single use. Each single-use vial should be entered only once. Vials with any unused material should be discarded after the initial entry.

Unopened, unused vials of Infasurf® that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Infasurf® should not be removed from the refrigerator for more than 24 hours. Infasurf® should not be returned to the refrigerator more than once. Repeated warming to room temperature should be avoided.

Foaming at the surface and visible flecks in the suspension are normal for Infasurf®. Infasurf® is a suspension which settles during storage. Gentle swirling or agitation of the vial is often necessary for resuspension. DO NOT SHAKE.

Visible flecks in the suspension and foaming at the surface are normal for Infasurf®. Infasurf® is a suspension which settles during storage. Gentle swirling or agitation of the vial is often necessary for resuspension. DO NOT SHAKE.

Each dose of Infasurf is 3 mL/kg body weight at birth.

Infasurf® prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth. Prophylaxis therapy at birth with Infasurf® is indicated for premature infants <29 weeks of gestational age at significant risk for RDS.

Administration of Infasurf® has been studied in clinical trials using 2 or 4 aliquots. Single bolus administration would be at the discretion of a Medical Doctor.

The only FDA approved method for the instillation of any FDA approved surfactant preparation is into the trachea through an endotracheal tube. While alternative methods of surfactant delivery have been published, none have been reviewed and approved by the FDA.

To order Infasurf® in the U.S., please contact your primary wholesaler. For more information on ordering, please call Customer Service at 866.398.0820 or submit an inquiry online by visiting our Request Information page.

Infasurf® (calfactant) Intratracheal Suspension is supplied sterile in single-use, rubber-stoppered glass vials containing 3 mL (NDC 61938-456-03) or 6 mL (NDC 61938-456-06) off-white suspension.

Yes, we are currently approved for use in 25 different countries around the world. If you’re interested in acquiring Infasurf® for use outside the United States, please contact us by calling 877.274.4669 or submit an inquiry online by visiting our Request Information page.

To schedule an in-service or education for your hospital, please call 877.274.4669 or visit our Request Information page to submit a request.

Yes, we have a variety of resources for Infasurf®. Please visit our Resources page for downloadable materials and links to additional resources. Should you have any additional questions, please visit our Request Information page to submit a request.

To report an adverse event, please call 877.663.4179 or email us at safety@onybiotech.com.

For product support, please call 877.274.4669 or email us at product@onybiotech.com.

To contact a sales representative, please call 877.274.4669 or visit our Request Information page to submit a request.

To reach Medical Affairs, please call 877.274.4669 or email us at info@onybiotech.com.