Calfactant

Mechanism-of-action class: Surfactant Activity.

• 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.

• None. None.contraindicated

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 INFASURF after the initial vial entry. 2.3 Administration Instructions INFASURF should be administered by healthcare providers who are experienced in the acute care of neonates with RDS who require intubation. Two attendants should be present to facilitate dosing; one to instill the INFASURF, the other to monitor the neonate.

5.1 Acute Changes in Oxygenation and Lung Compliance The administration of exogenous surfactants, including INFASURF, can rapidly affect oxygenation and lung compliance. Frequently monitor neonates who receive INFASURF so that oxygen and ventilatory support can be modified in response to changes in respiratory status. INFASURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm neonates with RDS who require intubation. 5.2 Administration-Related Adverse Reactions Administration-related adverse reactions associated with INFASURF use included cyanosis, bradycardia, airway obstruction, and reflux of INFASURF into the endotracheal tube. These adverse reactions occurred more frequently in neonates who received repeat doses of INFASURF at 12-hour intervals than neonates that received colfosceril palmitate, the comparator, in randomized controlled trials (Trials 1 and 3) [ see Clinical Studies (14) ]. If these adverse reactions occur during INFASURF administration, stop INFASURF and institute appropriate measures to alleviate these adverse reactions and resume INFASURF with appropriate monitoring. 5.3 Intraventricular Hemorrhage and Periventricular Leukomalacia An increased proportion of INFASURF-treated neonates compared to colfosceril palmitate-treated neonates in randomized clinical trials (Trials 1 and 3) [ see Clinical Studies (14) ] developed intraventricular hemorrhage and periventricular leukomalacia. These adverse reactions were not associated with increased mortality in those studies.

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 tube (21%), requirement for manual ventilation (16%), and reintubation (3%). 6.2 Complications of RDS and Neurodevelopmental Outcomes Incidence of Common Complications of Prematurity The controlled trials of INFASURF included the incidence of common complications of prematurity and RDS as safety endpoints. Tables 1 and 2 display the results in the INFASURF vs.

8.4 Pediatric Use The safety and effectiveness of INFASURF have been established to reduce the risk of RDS in preterm neonates < 29 weeks of gestational age at risk for RDS and for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation, and the information on these uses is discussed throughout the labeling. The safety and effectiveness of INFASURF have not been established in older pediatric patients.

If respiration, ventilation, or oxygenation is clearly affected after an accidental overdose, aspirate as much of the intratracheal suspension as possible and provide the neonate with supportive treatment.

• Jul 1, 1998BLABLA020521Ony

1. 1Endotracheal Intubation Complication2540%
2. 2Oxygen Saturation Decreased1321%
3. 3Bradycardia69.5%
4. 4Cardio-respiratory Arrest57.9%
5. 5Pneumothorax46.3%
6. 6Death34.8%
7. 7Heart Rate Decreased34.8%
8. 8Neonatal Hypoxia34.8%
9. 9Obstruction34.8%
10. 10Product Quality Issue34.8%
11. 11Pulmonary Haemorrhage34.8%
12. 12Bradycardia Neonatal23.2%
13. 13Breath Sounds Absent23.2%
14. 14Cardiac Failure23.2%
15. 15Cardio-respiratory Arrest Neonatal23.2%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Calfactant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
  Recruiting · Phase 4 · Interventional · 234 enrolled · Uludag University
  NCT07350018updated 2026-04-28
• Little Lungs Study
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 24 enrolled · University of Wisconsin, Madison
  NCT06855043updated 2026-01-27
• Non Inferiority Trial Investigating Surfactants Administered Via MIST
  Recruiting · Phase 4 · Interventional · 262 enrolled · Endeavor Health
  NCT06074380updated 2025-08-07
• Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
  Terminated · Phase 1 · Phase 2 · Interventional · 25 enrolled · Cynthia McEvoy
  NCT02907593updated 2025-04-04
• InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
  Recruiting · Phase 3 · Interventional · 220 enrolled · ONY
  NCT05960929updated 2025-03-30
• Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
  Completed · Phase 3 · Interventional · 477 enrolled · ONY
  NCT03058666updated 2024-05-29
• Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
  No longer available · Expanded access · ONY
  NCT03582930updated 2023-11-07
• Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study
  Suspended · Phase 2 · Interventional · 55 enrolled · ONY
  NCT04056741updated 2023-11-01
• Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
  Completed · Phase 3 · Interventional · 511 enrolled · Roberta Ballard
  NCT01022580updated 2021-05-13
• Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
  Completed · Phase 3 · Interventional · 85 enrolled · Roberta Ballard
  NCT00569530updated 2021-05-11

Frequently asked questions

How does Calfactant work?

Mechanism-of-action class: Surfactant Activity.

What is Calfactant used for?

According to FDA labeling, Calfactant carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Calfactant?

Calfactant is classified as Surfactant, Surfactant Activity, Alveolar Surface Tension Reduction.

What are the brand names for Calfactant?

Calfactant is marketed under brand names including Infasurf.

What are the contraindications for Calfactant?

Calfactant labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.