Therefore, infants receiving curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to. The products dosage form is suspension, and is administered via endotracheal form. The nlm drug information portal gives users a gateway to selected drug information from the national library of medicine and other key government agencies. Each milliliter of suspension contains 80 mg of surfactant extract that includes 76 mg of phospholipids and 1 mg of protein of which 0. The amount of phospholipids is calculated from the content of phosphorus and contains 55 mg of phosphatidylcholine of which 30 mg is. List of offpatent, offexclusivity drugs without an approved. Pumactant and poractant alfa in respiratory distress. Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc. Refer to specific instruction provided by manufacturer for proper dosing technique. The incidence of death was similar between the beractant and poractant alfa groups in three studies 15,16,17 but significantly lower with beractant versus poractant alfa in 1 study 274 2. We did this because it meant we had the advantage of having a population from which to derive the power of the study and a mechanism to check for an unexpected deviation in mortality.
Curosurf 120mg vial endotracheopulmonary instillation. Slowly withdraw a little over the required dose into a 3 or 5 ml plastic. Curosurf poractant alfa is intended for intratracheal use only. Most of the early trials of poractant alfa were in europe where it. Pumactant and poractant alfa in respiratory distress syndrome. Curosurf is a white to creamy white suspension of poractant alfa. Capitals indicate lifethreatening, underlines indicate most frequent. A search of major electronic databases, including medline 19802010 and the cochrane central register of controlled trials, for randomized.
The administration of poractant through a duallumen endotracheal tube without a change in position or interruption of mechanical ventilation was compared to bolus instillation in a. They lower surface tension at the interface between the air in the lungs, specifically at the alveoli, and the blood in the capillaries. Poractant alfa versus beractant for respiratory distress. Poractant alfa curosurf is a natural, porcinederived. Curosurf poractant alfa intratracheal suspension is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only.
The use of a perforated vibrating membrane nebulizer provides a variety of advantages over conventional nebulizers. Dey laboratories application no 20744 approval date. Fio 2 auc 06 was significantly lower for both poractant alfa 100 mgkg p. Highlights of prescribing information these highlights do. In vitro and in vivo characterization of poractant alfa supplemented.
If the baby remains intubated, a second dose should be given 24 h from the time of intubation. In vitro characterization and in vivo comparison of the. Objective to compare calfactant ca and poractant alfa pa administration traits, shortterm clinical responses, and resource use in the neonatal respiratory distress syndrome rds setting. The administration of poractant curosurf through a duallumen endotracheal tube without a change in position or interruption of mechanical ventilation was. Poractant alfa curosurf, chiesi framaceutici, parma, italy is a natural surfactant suspension, prepared from minced porcine lungs, containing almost exclusively polar lipids, in particular, phosphatidylcholine pc, about 70% of the total phospholipid content, and about 1% of specific low molecular weight hydrophobic proteins spb and spc, at a phospholipid. Surfactant administration in the nicu royal childrens. Poractantalpha is supplied as 80 mg phospholipidml in 0. The only surfactant with single bolus administration option.
Pdf beractant and poractant alfa in premature neonates with. Prior to administration of poractant alfa, it is recommended that metabolic acidosis, anemia, hypoglycemia, hypotension, and hypothermia be corrected. As with other surfactants, marked improvement on oxygenation may occur within minutes of the administration of poractant alfa. Pdf beractant and poractant alfa in premature neonates. In this study, we assessed the influence of exogenous poractant alfa curosurf instillation on the in vivo phagocytosis of apoptotic neutrophils by alveolar macrophages. Poractant alfa in respiratory distress syndrome in preterm. Pdf a randomized, multicenter masked comparison trial of. The administration of poractant through a duallumen endotracheal tube without a change in position or interruption of mechanical ventilation was compared to bolus instillation in a randomized trial. Poractant alfa is a pulmonary surfactant sold under the brand name curosurf by chiesi farmaceutici. Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in australia of their safety or efficacy. Curosurf is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc.
Poractant alfa drug monograph pediatric care online. Study design randomized, partiallyblinded, multicenter trial. The efficacy of poractant alfa in rds is better than that of earlygeneration synthetic surfactants, and limited data are available regarding its efficacy versus new. The primary outcome was being alive and extubated at 48 hours post. Using surgical aseptic technique, cut a sterile 5 fg feeding tube to the length so that the tip lies 1 cm above the end of the endotracheal tube. Administered as one or two aliquots depending upon the instillation procedure.
Each milliliter of suspension contains 80 mg of surfactant extract that includes 76 mg of. Curosurf poractant alfa dosing, indications, interactions. Collectively, outcomes were similar with beractant and poractant alfa in rwe studies and pooled rcts. Poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. It is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc. Review guidelines for storage, preparation, dosing, and administration of curosurf. Poractant alfa definition of poractant alfa by medical. Consumer information use if your childs symptoms or health problems do not get better or if they become worse, call your childs doctor. Beractant and poractant alfa in premature neonates with. Follow instructions carefully regarding installation of drug and ventilation of infant. Most of the early trials of poractant alfa were in europe where it has been approved for marketing for more than 10 years. In vitro and in vivo characterization of poractant alfa. Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76 mg of phospholipids and 1 mg of protein of which 0.
Poractant alfa versus bovine lipid extract surfactant for. Pdf complications among premature neonates treated with. Jan 02, 2020 curosurf poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Poractant alfa 100 mgkg 125 mlkg or pumactant 100 mg 12 ml were administered according to the manufacturers guidelines. We did consider using the threedose regimen defined in the datasheet for pumactant for our trial, but decided to follow the dosing schedule that was in place in newcastle and liverpool. Nebulizing poractant alfa versus conventional instillation. Between 2005 and 2007, poractant alfa and beractant were alternated every month in our neonatal intensive care unit for 27 months. Pdf a cost minimization comparison of two surfactants. Pdf comparison of the pharmacoeconomics of calfactant. Curosurf poractant alfa intratracheal suspension is indicated for the rescue treatment of. Poractant alfa and calsurf are two natural surfactants widely used in china for the treatment of neonatal respiratory distress syndrome, which are extracted from porcine and calf lungs, respectively. Poractant alfa, a human prescription drug labeled by chiesi usa, inc. It is a natural porcine lung extract consisting of 99% polar lipids mainly phospholipids and approximately 1% hydrophobic low.
Sign in or purchase a subscription to access this content. The second dose was administered 12 h later to ventilated neonates if the oxygenation index fio 2 %xmean arterial pressure cm h 2 opao 2 mm hg was 5 or more. This information from lexicomp explains what you need to know about this medication, including what its used for, how to take it, its side effects, and when to call your healthcare provider. Beractant and poractant alfa in premature neonates with respiratory. Clearance of apoptotic neutrophils in the lung is an essential process to limit inflammation. Efficacy of surfactantta, calfactant and poractant alfa. The purpose of this experimental study was to compare their in vitro characteristics and in vivo effects in the improvement of pulmonary function and protection of lung injury. Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76. This ensures that the surfactant is administered intratracheal.
Infants poractant alfa or bovine lipid extract surfactant. In a study of 146 babies with respiratory distress syndrome the 28day mortality rate was 31% in the group who received poractant compared with 51% in the group who did not. Beractant and poractant alfa in premature neonates with respiratory distress syndrome. We investigated the molecular structure and integrity of poractant alfa pre. Nebulized surfactant therapy has been proposed as an alternative method of surfactant administration. Therefore, infants receiving curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. If you need to store poractant alfa curosurf at home, talk with your childs doctor, nurse, or pharmacist about how to store it. Pumactant and poractant alfa for treatment of respiratory. The administration of exogenous surfactants, including curosurf, can rapidly affect oxygenation and lung compliance. Objectives to compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants.
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. Curosurf poractant alfa is an intratracheal suspension available in vials. Apr 22, 2000 poractant alfa 100 mgkg 125 mlkg or pumactant 100 mg 12 ml were administered according to the manufacturers guidelines. Curosurf poractant alfa dose, indications, adverse effects. Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76 mg of phospholipids and. Curosurf is a white to creamy white suspension which should not be used if there are visible signs of deterioration. Please note that due to licensing arrangements with publishers, some downloads are being provided directly. Sales of curosurfr poractant alfa, a pulmonary surfactant, exceeded euro200m, growing by 14. Curosurf poractant alfa dose, indications, adverse. Efficacy of porcine versus bovine surfactants for preterm. Curosurf poractant alfa intratracheal suspension is available in sterile, readytouse, rubberstoppered clear glass vials containing one vial per carton.
Poractant alfa 200 mgkg was instilled intratracheally in the lungs of three months old adult male c57black 6 mice, followed by apoptotic neutrophil instillation. Aug 17, 2017 poractant alfa curosurf is a natural, porcinederived surfactant that is well established as an effective and generally welltolerated agent in the treatment of respiratory distress syndrome rds in preterm infants. Poractant alfa is an extract of natural porcine lung surfactant. Download our mobile app institutionsgroup practices. Fill the catheter with poractant alfa and discard excess through the catheter so that only the total dose to be given remains in the syringe. Mean fio 2 for 100 and 200 mgkg poractant alfa groups were significantly lower than that for the beractant group at all time points until six hours p 0.
To compare the efficacy of a porcine surfactant poractant alfa versus bovine surfactants beractant and calfactant with respect to clinical outcomes among preterm infants with respiratory distress syndrome. Poractant alfa and beractant are the commonly used animal derived surfactants in preterm infants with respiratory distress syndrome. The primary outcome was being alive and extubated at 48. Therefore, infants receiving curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to. Comparison of the pharmacoeconomics of calfactant and poractant alfa in surfactant replacement erapy. A total of 332 preterm infants at 2431 weeks gestation with respiratory distress syndrome rds were enrolled and allocated to three groups according to the surfactant instilled. Curosurf should not be instilled into a main stem bronchus.
A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. A cost minimization comparison of two surfactantsberactant and poractant alfa based upon prospectively designed, comparative clinical trial data. The ndc code 1012251003 is assigned to curosurf also known as. Group 1 n146, surfactantta, group 2 n96, calfactant, and group 3 n90, poractant alfa. A multicenter, randomized, controlled trial of lucinactant. Poractant alfa australian prescriber nps medicinewise. The treatment difference between lucinactant and poractant alfa for survival without bpd through 28 days was 4. S b ainsworth and colleagues results april 22, p 871 may have been biased against pumactant. A randomized, multicenter masked comparison trial of poractant alfa curosurf versus beractant survanta in the treatment of respiratory distress syndrome in preterm infants. Aug 30, 20 nebulized surfactant therapy has been proposed as an alternative method of surfactant administration. Curosurf poractant alfa intratracheal suspension company. Methods an open label series of 277 2 pa and 64 ca infants was evaluated for 445 administrations.
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