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Infasurf

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Infasurf

Infasurf Side Effects Center

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

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Infasurf in Detail - Patient Information: Side Effects

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Infasurf FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most common adverse reactions associated with Infasurf (calfactant) 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 (calfactant) 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 (calfactant)
(N=1001)
%
Exosurf
Neonatal®
(N=978)
%
Infasurf (calfactant)
(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 hemorrhage a 12 10 9 7
  IVH and PVLb 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 (calfactant) vs. Exosurf Neonatal® controlled trials demonstrated significant developmental delays in equal percentages of Infasurf (calfactant) and Exosurf Neonatal® patients.

Read the entire FDA prescribing information for Infasurf (Calfactant) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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