SurfactantPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Infasurf
CALFACTANT
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 h...
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Brand names:INFASURF
Quick Reference
Medicine ClassSurfactant
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- CALFACTANT
- Medicine class
- Surfactant
- Brand names
- INFASURF
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- FDA approved
- Yes
What Is Infasurf?
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 h...
Infasurf (CALFACTANT) belongs to the Surfactant class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Infasurf. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Infasurf with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Infasurf is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
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.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
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
Available Forms
Available Strengths
Side Effects
Common
- 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 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.
- colfosceril palmitate trials and the INFASURF and beractant trials, respectively.
- Trials 1, 2, and 3 were not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the INFASURF and the colfosceril palmitate and beractant treatment groups.
Serious
- 5 WARNINGS AND PRECAUTIONS 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) ].
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS 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
How Infasurf Works
Pharmacokinetics
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Infasurfwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
Related on MedCentralHub
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Infasurf
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.