INFASURF 35.7 mg/mL
calfactant · SUSPENSION · ONY Biotech Inc.
INFASURF is a suspension containing calfactant at 35.7 mg/mL, taken endotracheal. Manufactured by ONY Biotech Inc..
Key Facts
- Brand Name
- INFASURF
- Generic Name
- calfactant
- NDC Code (Product)
61938-456- Manufacturer
- ONY Biotech Inc.
- Strength
- 35.7 mg/mL
- Dosage Form
- SUSPENSION
- Route
- ENDOTRACHEAL
- Marketing Status
- Application #
- BLA020521
- Drug Class
- Surfactant [EPC]
- Marketing Start
- 10/18/1999
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. INFASURF ® is a surfactant indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates < 29 weeks gestational age at risk for RDS. (1) for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dose of INFASURF is 3 mL/kg body weight at birth administered intratracheally through an endotracheal tube. INFASURF can be administered every 12 hours for a total of up to three doses. To reduce the risk of RDS in preterm neonates <29 weeks of gestational age at risk for RDS, administer INFASURF within 30 minutes after birth. 2.2 Preparation Instructions INFASURF does not require reconstitution. Do not dilute or sonicate. INFASURF does not need to reach room temperature before administration. Gently swirl or agitate the INFASURF intratracheal suspension vial for redispersion. Do not shake. Visually inspect the INFASURF intratracheal suspension for discoloration prior to administration. The color of the INFASURF intratracheal suspension should be off-white. Discard the INFASURF vial if the intratracheal suspension is discolored. Visible flecks in the intratracheal suspension and foaming at the surface are normal. Using a 20-gauge or larger needle and syringe to avoid excessive foaming, withdraw INFASURF from the vial. Discard unopened INFASURF vials stored at room temperature for more than 24 hours. Discard unused I…
Contraindications
4 CONTRAINDICATIONS None. None.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Acute Changes in Oxygenation and Lung Compliance [ see Warnings and Precautions (5.1 )] Administration-Related Adverse Reactions [see Warnings and Precautions (5.2) ] Intraventricular Hemorrhage and Periventricular Leukomalacia [ see Warnings and Precautions (5.3) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of INFASURF is based on the pooled safety population from three, randomized, active-controlled clinical trials that evaluated INFASURF to reduce the risk of respiratory distress syndrome (RDS) and rescue treatment of RDS [ see Clinical Studies (14) ], which included 1,554 preterm neonates who received at least one dose of INFASURF. The most common INFASURF administration-related adverse reactions were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tu…
Frequently Asked Questions
What is INFASURF used for?
INFASURF contains calfactant. It is a suspension taken endotracheal. Consult your doctor for specific uses.
Is INFASURF a controlled substance?
INFASURF is not classified as a controlled substance by the DEA.
What is the generic name for INFASURF?
The generic name for INFASURF is calfactant. There are no other listed brand versions of calfactant.
What is the NDC code for INFASURF 35.7 mg/mL?
The NDC (National Drug Code) for INFASURF 35.7 mg/mL is 61938-456, listed by ONY Biotech Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)