Contained within these pages are the realized hopes and dreams of millions of americans affected by rare diseases. It is an extract of natural porcine lung surfactant which consists of 99% polar lipids and 1% hydrophobic. Poractant alfa curosurf calfactant infasurf rescue vs prophylactic treatment administration 6. Curosurf poractant alfa intratracheal suspension company. The primary outcome was being alive and extubated at 48 hours post. List of offpatent, offexclusivity drugs without an. 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. In vitro characterization and in vivo comparison of the. Infants poractant alfa or bovine lipid extract surfactant. It is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1 % hydrophobic low molecular.
Ideal sources for wikipedia s health content are defined in the guideline wikipedia. Curosurf reduces mortality and pneumothoraces associated with rds. Objectives to compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants. Fentanylbupivicaine epidural ob epidural postpartum hemorrhage. Ncpap treatment was also performed as described above. 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. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. Original article comparison of the efficacy and safety of. 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. Intratracheal administration of chf5633 to preterm newborn rabbits resulted in marked improvement in lung expansion which is no different from poractantalfa. Beractant and poractant alfa in premature neonates with respiratory. This study compared administration characteristics including administration time, patient recovery time, reflux and bradycardia. 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. The trip database provides clinical publications about evidence.
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. Collectively, outcomes were similar with beractant and poractant alfa in rwe studies and pooled rcts. Pdf we compared the onset of clinical response and safety of two surfactants. The search was also limited to english language documents published. Aerobid, aerospan hfa genercic nasal spray fluticasone. Comparison of the efficacy and safety of bovine lung phospholipid. Formulary update redosing of reversal agents in the. As with other surfactants, marked improvement on oxygenation may occur within minutes of the administration of poractant alfa. The newborns in group b were injected with poractant alfa injection curosurf at a dose of 70 mgkg.
Respiratory care in the nicu cynthia jensen, rncnic, ms, cns ucsf bch perinatal outreach program june, 2018. 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. 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. Information on the cost of poractant alfa in the us was identified, however no costeffectiveness evaluations were identified. 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. 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. Evaluation of biases is reported in the additional file 1.
Poractant alfa is a pulmonary surfactant sold under the brand name curosurf by chiesi farmaceutici. Curosurf poractant alfa for the treatment of infants at. Original article a comparative study of two noninvasive. Curosurf poractant alfa is an intratracheal suspension available in vials. Sales of curosurfr poractant alfa, a pulmonary surfactant, exceeded euro200m, growing by 14.
Curosurf poractant alfa for the treatment of infants. Federal food, drug, and cosmetic act fdca for curosurf poractant alfa suspension. Insure strategy selective surfactant following ncpap failure. Poractant alfa definition of poractant alfa by medical.
This policy delineates the care for neonatal patients who require treatment for respiratory distress. Volume 17 pharmacy pharmacy focus valley health system. Pdf a cost minimization comparison of two surfactants. 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. In response to mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant. 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. Curosurf poractant alfa dose, indications, adverse. Nebulized surfactant, poractant alfa, eflowneos, respiratory distress syndrome, cpap, neonatal. This prior approval supplemental new drug application provides for changes to the dosage and administration section of the labeling.
Prior to administration of poractant alfa, it is recommended that metabolic acidosis, anemia, hypoglycemia, hypotension, and hypothermia be corrected. 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. Poractant alfa 200 mgkg was instilled intratracheally in the lungs of three months old adult male c57black 6 mice, followed by apoptotic neutrophil instillation. 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. Mortality in preterm infants with respiratory distress syndrome. Surfactant psd and rf in presence of different prongs were investigated by laserdiffraction and next generation impactor. Highlights of prescribing information these highlights do. A study on the safety and efficacy of reveglucosidase alfa. This guideline applies to all members of the indiana university lifeline critical care transport team. Animal research guiding clinical practice oral presentations abstracts organising institutions.
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. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Poractant alfa is an extract of natural porcine lung surfactant. Curosurf poractant alfa intratracheal suspension is available in sterile, readytouse, rubberstoppered clear glass vials containing one vial per carton. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
The search was also limited to english language documents. The poractant alfa injection was put into the syringe at a dose of 200 mgkg, and then it was injected once and. However, the price of poractant alfa is higher and may not be costeffective in. Poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76. Bovine lung phospholipid or poractant alfa injections in the treatment of nhmd with cpap 3009 int j clin exp med 2019. Clearance of apoptotic neutrophils in the lung is an essential process to limit inflammation. Curosurf poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Study design randomized, partiallyblinded, multicenter trial. There is some evidence that porcinederived surfactant, poractant alfa, may be more. Treatment with poractant alfa 200 mgkg initial dose resulted in rapid reduction in. 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.
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. The list is based on the orange book data files, accessed october 18, 2019. Curosurf poractant alfa is intended for intratracheal use only. Poractant alfa versus bovine lipid extract surfactant for. Poractant alfa drug monograph pediatric care online. A decade of innovationdoesnt just describe a period of stunning medical advances, it documents a brief window in time during.
1284 423 270 490 628 1129 399 643 825 156 490 422 102 121 331 1115 22 699 348 324 367 108 344 1193 521 1293 1329 469 404 1427