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Curosurf

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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

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adverse Reactions in Studies in Premature Infants with Respiratory Distress Syndrome

The safety data described below reflect exposure to CUROSURF at a single dose of 2.5 mL/kg (200 mg/kg), in 78 infants of 700-2000 grams birth weight with RDS requiring mechanical ventilation and a FiO2 ≥ 0.60 (Study 1) [see Clinical Studies]. A total of 144 infants were studied after RDS developed and before 15 hours of age; 78 infants received CUROSURF 2.5 mL/kg single dose (200 mg/kg), and 66 infants received control treatment (disconnection form the ventilator and manual ventilation for 2 minutes).

Transient adverse effects seen with the administration of CUROSURF included bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. The rates of the most common serious complications associated with prematurity and RDS observed in Study 1 are shown in Table 2.

Table 2: Most Common Serious Complications Associated with Prematurity and RDS in Study 1

  CUROSURF 2.5 mL/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.

Seventy-six infants (45 treated with CUROSURF) from study 1 were evaluated at 1 year of age and 73 infants (44 treated with CUROSURF) were evaluated at 2 years of age to assess for potential long-term adverse reactions. 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 and 6 controls) evaluated at 5.5 years of age, the developmental quotient, derived using the Griffiths Mental Developmental Scales, was similar between groups.

Immunogenicity

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

Postmarketing Experience

Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported both in clinical trials with CUROSURF and in postmarketing adverse event reports in infants who had received CUROSURF.

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

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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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