Curosurf (Poractant)

Brand Name

Curosurf

Generic Name

Poractant

View Brand Information

FDA approval date: November 18, 1999

Classification: Surfactant

Form: Suspension

What is Curosurf (Poractant)?

CUROSURF ® Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome in premature infants.

Approved To Treat

Premature Infant

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Brand Information

Curosurf (poractant alfa)

1INDICATIONS AND USAGE

CUROSURF

2DOSAGE FORMS AND STRENGTHS

Intratracheal suspension: CUROSURF (poractant alfa) is a white to creamy white suspension available in:

120 mg/1.5 mL (80 mg/mL) single-dose vials
240 mg/3 mL (80 mg/mL) single-dose vials

3CONTRAINDICATIONS

None.

4OVERDOSAGE

There have been no reports of overdosage following the administration of CUROSURF.

In the event of accidental overdosage, and if there are clear clinical effects on the infant's respiration, ventilation, or oxygenation, aspirate as much of the suspension as possible and provide the infant with supportive treatment, with particular attention to fluid and electrolyte balance.

5DESCRIPTION

Poractant alfa is an extract of natural porcine lung (pulmonary) surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight surfactant associated proteins (SP). The molecular weight of SP-B is 8.7 KDa and the molecular weight of SP-C is 3.7 KDa.

CUROSURF (poractant alfa) intratracheal suspension is a sterile, white to creamy white suspension provided in a single-dose vial for intratracheal use. Each milliliter of suspension contains 80 mg of poractant alfa (surfactant extract) that includes 76 mg of phospholipids and 1 mg of SP of which 0.45 mg is SP-B, a 79-amino acid protein and 0.59 mg is SP-C, a 35-amino acid peptide . The amount of phospholipids is calculated from the content of phosphorus and contains 55 mg of phosphatidylcholine of which 30 mg is dipalmitoylphosphatidylcholine. It is suspended in 0.9% sodium chloride solution. The pH is adjusted with sodium bicarbonate to a pH of 6.2 (5.5 to 6.5).

Curosurf contains no preservatives.

6HOW SUPPLIED/STORAGE AND HANDLING

CUROSURF (poractant alfa) intratracheal suspension is a white to creamy white suspension available in sterile, rubber-stoppered clear glass vials containing (one vial per carton):

120 mg/1.5 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension: NDC Number: 10122-510-01
240 mg/3 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension. NDC Number: 10122-510-03

Store CUROSURF intratracheal suspension in a refrigerator at +2°C to +8°C (36°F to 46°F). PROTECT FROM LIGHT. Do not shake. Vials are for single-dose only. After opening the vial discard the unused portion

Manufactured by:

Chiesi USA, Inc.

Cary, NC 27518

U.S.License No. 2150

Manufactured at and licensed from:

Chiesi Farmaceutici, S.p.A.

Parma, Italy 43100

CTC-007-0320-03-SPL-2