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Curosurf

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Curosurf

Curosurf

Curosurf Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Curosurf (poractant alfa) Suspension is a pulmonary surfactant used to treat Respiratory Distress Syndrome (RDS) in premature infants. It reduces mortality and pneumothoraces (collapsed lung) associated with RDS. Common side effects include slow heart rate, low blood pressure, endotracheal tube blockage, and low blood oxygen levels. Many side effects are associated with premature birth.

The initial recommended dose of Curosurf is 2.5 mL/kg birth weight. Curosurf may interact with other drugs. Tell your doctor all medications and supplements your child uses. Curosurf is intended for premature infants and is unlikely to be used in pregnant or breastfeeding women.

Our Curosurf (poractant alfa) Suspension 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 Prescribing information?

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

Curosurf FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Transient adverse effects seen with the administration of CUROSURF (poractant alfa) include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. Pulmonary Hemmorhage is a known complication of premature birth and very low birth-weight and has been reported both in clinical trials with Curosurf (poractant alfa) and in post-marketing adverse event reports in infants who had received Curosurf (poractant alfa) . The rates of common complications of prematurity observed in Study 1 are shown below in Table 3.

TABLE 3

COMPLICATIONS OF PREMATURITY
  CUROSURF (poractant alfa) 2.5 mL/kg
(200 mg/kg)
n=78
%
CONTROL *
n=66
%
Acquired Pneumonia 17 21
Acquired Septicemia 14 18
Bronchopulmonary Dysplasia 18 22
Intracranial Hemorrhage 51 64
Patent Ductus Arteriosus 60 48
Pneumothorax 21 36
Pulmonary Interstitial Emphysema 21 38
* Control patients were disconnected from the ventilator and manually ventilated for 2 minutes. No surfactant was instilled.

Immunological studies have not demonstrated differences in levels of surfactant-anti-surfactant immune complexes and anti-CUROSURF (poractant alfa) antibodies between patients treated with CUROSURF (poractant alfa) and patients who received control treatment.

Follow -Up Evaluations

Seventy-six infants (45 treated with CUROSURF (poractant alfa) ) were evaluated at 1 year of age and 73 infants (44 treated with CUROSURF (poractant alfa) ) at 2 years of age. Data from follow-up evaluations for weight and length, persistent respiratory symptoms, incidence of cerebral palsy, visual impairment, or auditory impairment was similar between treatment groups. In 16 patients (10 treated with CUROSURF (poractant alfa) and 6 controls) evaluated at 5.5 years of age, the developmental quotient, derived using the Griffths Mental Developmental Scales, was similar between groups.

Read the entire FDA prescribing information for Curosurf (Poractant Alfa) »

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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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