Curosurf

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Curosurf

Classes

Lung Surfactants

Administration
Other Administration Route(s)

Intratracheal Administration
Curosurf (poractant alfa) is only for intratracheal administration by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.
Prior to administration of poractant alfa, it is recommended that metabolic acidosis, anemia, hypoglycemia, hypotension, and hypothermia be corrected.
 
Preparation:
Poractant alfa is ready-to-use; no reconstitution or dilution is necessary.
Slowly warm vial to room temperature and gently turn upside-down in order to obtain a uniform suspension. DO NOT SHAKE.
Record the date and time of warming on the vial carton.
Use a 20-gauge or larger needle to withdraw the required dose from the vial into a 3 or 5 mL syringe.
Storage: Unopened, unused vials may be returned to refrigeration within 24 hours of warming. Vials that have been warmed to room temperature should not be returned after 24 hours or returned more than once. Protect from light.
 
Intratracheal instillation:
NOTE: FOR INTRATRACHEAL ADMINISTRATION ONLY.
Carefully follow the detailed dosage and administration instructions from the manufacturer.
At the discretion of the clinician, the endotracheal tube may be suctioned prior to administration. Allow the patient to stabilize before proceeding with dosing.
Administration is via a 5 French end-hole catheter; alternatively, it can be instilled using the secondary lumen of a dual lumen endotracheal tube.
If a 5 French catheter is used, immediately before administration, the infant's ventilator settings should be changed to a rate of 40 to 60 breaths/minute, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain SaO2 greater than 92%. Keep the infant in a neutral position (head and body in alignment without inclination).
The manufacturer recommends that the total dose be divided into two equal aliquots. Each aliquot is administered into one of the two main bronchi by positioning with either the right or left side dependent. This ensures homogenous distribution throughout the lungs.
On completion of the dosing procedure the usual ventilator management and clinical care should be resumed. In clinical trials, ventilator management was modified to maintain a PaO2 of approximately 55 mmHg, PaCo2 of 35 to 45, and pH greater than 7.3.

Adverse Reactions
Severe

apnea / Delayed / Incidence not known
bradycardia / Rapid / Incidence not known
cyanosis / Early / Incidence not known
hypocarbia / Rapid / Incidence not known

Moderate

hypotension / Rapid / Incidence not known
hypoxia / Early / Incidence not known
hyperoxia / Rapid / Incidence not known
bleeding / Early / Incidence not known

Common Brand Names

Curosurf

Dea Class

Rx

Description

Porcine-derived lung surfactant
Used to treat neonatal respiratory distress syndrome (RDS)
Has been used off label for acute respiratory syndrome following near drowning

Dosage And Indications
For the rescue treatment of neonatal respiratory distress syndrome (RDS). Intratracheal dosage Premature neonates

2.5 mL/kg/dose of birth weight intratracheally divided in 1 or 2 aliquots. May administer up to 2 subsequent doses of 1.25 mL/kg/dose at 12-hour intervals if needed. The maximum recommended total dose (sum of all aliquots) is 5 mL/kg. The safety and efficacy of administering poractant alfa more than 15 hours after the initial diagnosis of neonatal RDS has not been established. Adequate data are not available on the use of poractant alfa in conjunction with experimental therapies of RDS (e.g., high-frequency ventilation).

For the treatment of acute respiratory distress syndrome (ARDS)† due to near-drowning. Intratracheal dosage Adults

50 mg/kg instilled via bronchoscope as 3 aliquots to each lobe of 1 lung and repeated for other lung upon respiratory deterioration and about every 12 hours alternating sides for a total of 6 applications (3 applications/lung).[26017]

Infants, Children, and Adolescents

40 or 50 mg/kg intratracheally as a single aliquot.[51776] [51777]

Neonates

100 mg/kg intratracheally as a single aliquot and repeated 4 hours later for improving but ongoing hypoxemia.

†Indicates off-label use

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that dosage adjustments are not needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that dosage adjustments are not needed.

Drug Interactions

Amikacin: (Major) Some surfactant antiinfective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. A reduced activity of tobramycin, a commonly nebulized aminoglycoside, has been reported in the presence of surfactant. Use the combination of amikacin and surfactants with caution.
Amphotericin B: (Major) Some surfactant-anti-infective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. Surfactants should not be mixed with anti-infectives that are commonly administered via nebulization such as amphotericin B.
Gentamicin: (Major) Aminoglycosides are commonly given via nebulization to the airway for the prevention and treatment of pneumonia and are known to be at risk for inactivation of their antibiotic activity, mainly due to their susceptibility for changes in pH. A reduced activity of gentamicin may occur in the presence of surfactant.
Neomycin: (Major) Some surfactant antiinfective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation.
Streptomycin: (Moderate) A reduced activity of streptomycin may occur in the presence of surfactant when given via nebulization.
Tobramycin: (Major) Some surfactant anti infective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. A reduced activity of tobramycin, a commonly nebulized aminoglycoside, has been reported in the presence of surfactant.
Vancomycin: (Major) Some surfactant-anti-infective mixtures have been shown to affect the in vivo activity of exogenous pulmonary surfactants when they are administered via inhalation. Pulmonary surfactants should not be mixed with anti-infectives that are commonly administered via nebulization such as vancomycin.

How Supplied

Curosurf Endotracheal Susp: 1mL, 80mg

Maximum Dosage
Adults

Safety and efficacy have not been established.

Geriatric

Safety and efficacy have not been established.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

2.5 ml/kg (birth weight)/dose intratracheally.

Mechanism Of Action

Poractant alfa exhibits actions similar to natural pulmonary surfactant. Poractant alfa reduces the surface tension at the air-liquid interface on alveolar surfaces during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. This leads to an improvement in lung compliance and respiratory gas exchange. Additionally, in vitro data suggest that poractant alfa causes a substantial reduction in tumor necrosis factor output from human monocytes, thereby producing antiinflammatory effects within the alveolar space.
 
Natural pulmonary surfactant contains a mixture of roughly 90% phospholipids (e.g., phosphatidylcholine and phosphatidylglycerol) and 10% associated surfactant proteins (i.e., SP-A, SP-B, SP-C and SP-D). Poractant alfa consists of about 99% phospholipids and 1% surfactant associated proteins (SP-B and SP-C only). The exact role of all the components of natural human pulmonary surfactant is uncertain, and of great scientific interest. Phospholipids adsorb rapidly to the surface of the air:liquid interface of the lung lumen and modify the surface tension within the alveoli. Surfactant-associated proteins, particularly SP-B, appear to be essential in binding, stabilizing, spreading, and recycling phospholipids on the alveolar surfaces. It has been recently discovered that some infants who develop fatal RDS have a genetic deficiency or a genetic mutation of the SP-B protein. Proteins SP-A and SP-D, which are not currently components of exogenous surfactant products, appear to have additional functions relating to host defenses in the lung.

Pharmacokinetics

Poractant Alfa is administered directly to the lungs. Human pharmacokinetic studies to characterize the absorption, metabolism, and excretion of poractant alfa have not been performed.

Other Route(s)

Intratracheal route
Animal data indicate that approximately 50% of a radiolabeled dose of poractant alfa is rapidly removed from the alveoli in the first three hours after a single intratracheal dose. Within a 24-hour period, approximately 45% of the dose was cleared from the lungs in adult rabbits compared to 20% in newborns. In the newborn rabbits, radiolabeled drug passed from the alveolar space into the lung parenchyma and then was secreted again into the alveoli, whereas in adult rabbits, most of the radiolabeled drug was not recycled. The concentration of radiolabeled drug in alveolar macrophages was <= 2% of that in the lung in newborn and adult rabbits. Of the total radiolabeled drug recovered in newborn rabbits, < 0.6% was found in the serum, liver, kidneys, and brain at 48 hours. The half-life in the lung appeared to be about 25 hours in adult rabbits and 67 hours in newborn rabbits.

Pregnancy And Lactation
Pregnancy

Poractant alfa (Curosurf) has not been assigned an FDA category for pregnancy risk. Clinical studies in women or animals during pregnancy are not available. Poractant alfa should only be administered to pregnant women where the potential benefit of the medication would outweigh the unknown risks to the fetus.

There are no data on the use of poractant alfa (Curosurf) during lactation. Since data are not available, poractant alfa should be administered with caution during breast-feeding.