Pdf a cost minimization comparison of two surfactants. Treatment with poractant alfa 200 mgkg initial dose resulted in rapid reduction in. 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. A cost minimization comparison of two surfactantsberactant and poractant alfabased upon prospectively designed, comparative clinical trial data article pdf available. Pdf in vivo evaluation of the acute pulmonary response. The newborns in group b were injected with poractant alfa injection curosurf at a dose of 70 mgkg. An openlabel comparison of calfactant and poractant alfa administration traits and impact on neonatal intensive care unit resources gerdes js, seiberlich w, sivieri em, et al. There is some evidence that porcinederived surfactant, poractant alfa, may be more. Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76. Animal research guiding clinical practice oral presentations abstracts organising institutions. Mortality in preterm infants with respiratory distress syndrome. Prior to administration of poractant alfa, it is recommended that metabolic acidosis, anemia, hypoglycemia, hypotension, and hypothermia be corrected. Poractant alfa curosurf calfactant infasurf rescue vs prophylactic treatment administration 6.
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. The poractant alfa injection was put into the syringe at a dose of 200 mgkg, and then it was injected once and. The search was also limited to english language documents. This prior approval supplemental new drug application provides for changes to the dosage and administration section of the labeling.
Objectives to compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants. Curosurf poractant alfa is intended for intratracheal use only. Curosurf poractant alfa intratracheal suspension 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. Poractant alfa is a pulmonary surfactant sold under the brand name curosurf by chiesi farmaceutici. Poractant alfa curosurf increases phagocytosis of apoptotic neutrophils by alveolar macrophages in vivo coen hmp willems1, florian urlichs2, silvia seidenspinner2, steffen kunzmann2, christian p speer2 and boris w kramer1,2,3 abstract background. Nebulized surfactant, poractant alfa, eflowneos, respiratory distress syndrome, cpap, neonatal. Intratracheal administration of chf5633 to preterm newborn rabbits resulted in marked improvement in lung expansion which is no different from poractantalfa. 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. Curosurf poractant alfa july 2009 announced agreement to acquire rights to factive from oscient pharmaceuticals december 2011 announced acquisition of cardiokine inc. 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.
A study on the safety and efficacy of reveglucosidase alfa. The administration of exogenous surfactants, including curosurf, can rapidly affect oxygenation and lung compliance. Poractant alfa, and all surfactants, should only be ordered and administered by clinicians with training and experience in. Original article a comparative study of two noninvasive. The search was also limited to english language documents published. Infants poractant alfa or bovine lipid extract surfactant.
Curosurf poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. It is an extract of natural porcine lung surfactant which consists of 99% polar lipids and 1% hydrophobic. Curosurf poractant alfa intratracheal suspension company. Insure strategy selective surfactant following ncpap failure. Curosurf poractant alfa is an intratracheal suspension available in vials. In response to mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant.
The list is based on the orange book data files, accessed october 18, 2019. Curosurf reduces mortality and pneumothoraces associated with rds. Fentanylbupivicaine epidural ob epidural postpartum hemorrhage. Surfactant psd and rf in presence of different prongs were investigated by laserdiffraction and next generation impactor. 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. List of offpatent, offexclusivity drugs without an.
Ideal sources for wikipedia s health content are defined in the guideline wikipedia. Collectively, outcomes were similar with beractant and poractant alfa in rwe studies and pooled rcts. Poractant alfa definition of poractant alfa by medical. Beractant and poractant alfa in premature neonates with respiratory. Curosurf poractant alfa intratracheal suspension is available in sterile, readytouse, rubberstoppered clear glass vials containing one vial per carton. This guideline applies to all members of the indiana university lifeline critical care transport team. However, the price of poractant alfa is higher and may not be costeffective in. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Information on the cost of poractant alfa in the us was identified, however no costeffectiveness evaluations were identified. Ncpap treatment was also performed as described above.
Contained within these pages are the realized hopes and dreams of millions of americans affected by rare diseases. In vitro characterization and in vivo comparison of the. Poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Poractant alfa 200 mgkg was instilled intratracheally in the lungs of three months old adult male c57black 6 mice, followed by apoptotic neutrophil instillation. Poractant alfa versus bovine lipid extract surfactant for. Comparison of the efficacy and safety of bovine lung phospholipid.
Poractant alfa rabbit antithymocyte globulin thymoglobulin c1 esterase inhibitor, recombinant yeast saccharomyces cerevisiae albiglutide becaplermin desirudin hepatitis b vaccine recombivax hb inulin novolin insulin aspart novolog insulin degludec tresiba. Original article comparison of the efficacy and safety of. Porcine versus bovine surfactant therapy for rds in. 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 curosurf worlds leading surfactant composition. Study design randomized, partiallyblinded, multicenter trial. Volume 17 pharmacy pharmacy focus valley health system. This study compared administration characteristics including administration time, patient recovery time, reflux and bradycardia.
Respiratory care in the nicu cynthia jensen, rncnic, ms, cns ucsf bch perinatal outreach program june, 2018. Curosurf poractant alfa for the treatment of infants at. Clearance of apoptotic neutrophils in the lung is an essential process to limit inflammation. As with other surfactants, marked improvement on oxygenation may occur within minutes of the administration of poractant alfa. Poractant alfa is an option for smaller babies, weighing 1500 grams or less, as the volume administered per dose is 50 to 60% of the dosing volume of calfactant. Pdf we compared the onset of clinical response and safety of two surfactants. Poractant alfa is an extract of natural porcine lung surfactant. Sales of curosurfr poractant alfa, a pulmonary surfactant, exceeded euro200m, growing by 14. Aerobid, aerospan hfa genercic nasal spray fluticasone. 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. Curosurf poractant alfa for the treatment of infants. In vitro characterization and in vivo comparison of the pulmonary outcomes of poractant alfa and calsurf in ventilated preterm rabbits plos one, mar 2020 xiaojing guo, siwei luo, davide amidani, claudio rivetti, giuseppe pieraccini, barbara pioselli, silvia catinella, xabi murgia.
Respiratory system drugs created by the njardarson group the university of arizona. Evaluation of biases is reported in the additional file 1. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. Federal food, drug, and cosmetic act fdca for curosurf poractant alfa suspension. Authors of the study that included cost concluded that the cost of poractant alfa could be a limiting factor for its use in the us. A decade of innovationdoesnt just describe a period of stunning medical advances, it documents a brief window in time during. Curosurf poractant alfa dose, indications, adverse. Ony untitled letter infasurf is indicated for the prevention of rds in highrisk premature infants and, according to its pi, for the treatment rescue of premature infants who develop rds. Poractant alfa drug monograph pediatric care online. The primary outcome was being alive and extubated at 48 hours post. The trip database provides clinical publications about evidence. 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. Bovine lung phospholipid or poractant alfa injections in the treatment of nhmd with cpap 3009 int j clin exp med 2019.
67 175 1657 1632 594 412 309 3 542 1414 1634 832 1609 455 216 550 671 792 1662 1688 1418 1375 1027 791 705 643 1606 384 737 850 504 399 289 1466 661 1271 152 1167 983 624 1255 540