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Infasurf

Last reviewed on RxList: 7/18/2017
Infasurf Side Effects Center

Last reviewed on RxList 7/18/2017

Infasurf (calfactant) is a lung surface acting agent, or "surfactant," used to treat or prevent respiratory distress syndrome (RDS) in a premature baby whose lungs have not fully developed. Infasurf helps the lungs function normally. Infasurf causes few side effects. There is a possibility the baby will have breathing difficulties during treatment with Infasurf, and these problems may require further treatment.

Each dose of Infasurf is 3 mL/kg body weight at birth. Infasurf has been administered every 12 hours for a total of up to 3 doses. Drug interactions between Infasurf and other medications are not expected to occur. Your baby's caregivers will manage and monitor all medications given to your baby during treatment in the NICU. Because this drug is intended for premature babies, it is unlikely to be used by pregnant or breastfeeding women.

Our Infasurf (calfactant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Infasurf Consumer Information

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.

Read the entire detailed patient monograph for Infasurf (Calfactant)

Infasurf Professional Information

SIDE EFFECTS

The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death. The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in Table 3. Prophylaxis and treatment study results for each surfactant are combined.

Table 3 : Common Complications of Prematurity and RDS in Controlled Trials

Complication Infasurf
(N=1001) %
Exosurf Neonatal®
(N=978) %
Infasurf
(N=553) %
Survanta®
(N=566) %
Apnea 61 61 76 76
Patent ductus arteriosus 47 48 45 48
Intracranial hemorrhage 29 31 36 36
  Severe intracranial hemorrhagea 12 10 9 7
IVH and PVL b 7 3 5 5
Sepsis 20 22 28 27
Pulmonary air leaks 12 22 15 15
  Pulmonary interstitial emphysema 7 17 10 10
Pulmonary hemorrhage 7 7 7 6
Necrotizing enterocolitis 5 5 17 18
a Grade III and IV by the method of Papile.
b Patients with both intraventricular hemorrhage and periventricular leukomalacia.

Follow-Up Evaluations

Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf vs. Exosurf Neonatal® controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal® patients.

Read the entire FDA prescribing information for Infasurf (Calfactant)

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© Infasurf Patient Information is supplied by Cerner Multum, Inc. and Infasurf Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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