Tamar Koleba1, Mary H H Ensom. 1. Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, University of British Columbia, and the Department of Pharmacy, Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia, Canada.
Abstract
BACKGROUND: Intravenous immunoglobulin (IGIV) is used in the treatment of a wide variety of immune disorders. To our knowledge, no comprehensive or systematic review on the pharmacokinetics of IGIV has been published despite the availability of many published individual studies. OBJECTIVE: To systematically review published studies of the pharmacokinetics of IGIV. METHODOLOGY: We conducted a search of PubMed/MEDLINE from January 1966-September 2005 and EMBASE from January 1980-September 2005 for English-language articles on the pharmacokinetics of IGIV. This search was supplemented by a bibliographic review of all relevant articles. RESULTS: Data elements extracted from these articles included study design, number of study subjects, indication for IGIV therapy, IGIV treatment regimen (formulation, dosage, and duration), pharmacokinetic parameters (clearance, volume of distribution, elimination rate constant, and half-life), analytic methodology, pharmacokinetic model, and blood sampling times. The United States Preventive Services Task Force rating scale was used to categorize the 50 pertinent citations identified in our literature search. According to the rating scale, 12 studies were level I (prospective, randomized, controlled studies), 3 were level II-1 (prospective, nonrandomized, controlled studies), 30 were level II-2 (prospective, nonrandomized, uncontrolled [cohort] studies), and 5 were level III (case reports or descriptive studies). CONCLUSION: The pharmacokinetics of IGIV shows considerable intra- and interpopulation variability among patients with normal immunoglobulin levels, patients with primary immunodeficiency diseases, bone marrow transplant recipients, patients with immune deficiency due to chronic lymphocytic leukemia or multiple myeloma, very low birth weight neonates, neonates with suspected sepsis, high-risk infants in the neonatal intensive care unit, high-risk infants with cardiopulmonary disease, children with cryptogenic West or Lennox-Gastaut syndrome, women and infants with fetal alloimmune thrombocytopenia, and women with recurrent spontaneous abortions. Despite the large number of studies characterizing the pharmacokinetics of IGIV, major literature gaps include lack of information on IGIV clearance or area under the curve parameters and target serum immunoglobulin G concentrations. Further study is needed to rigorously characterize the pharmacokinetic properties of IGIV in a range of patient populations.
BACKGROUND: Intravenous immunoglobulin (IGIV) is used in the treatment of a wide variety of immune disorders. To our knowledge, no comprehensive or systematic review on the pharmacokinetics of IGIV has been published despite the availability of many published individual studies. OBJECTIVE: To systematically review published studies of the pharmacokinetics of IGIV. METHODOLOGY: We conducted a search of PubMed/MEDLINE from January 1966-September 2005 and EMBASE from January 1980-September 2005 for English-language articles on the pharmacokinetics of IGIV. This search was supplemented by a bibliographic review of all relevant articles. RESULTS: Data elements extracted from these articles included study design, number of study subjects, indication for IGIV therapy, IGIV treatment regimen (formulation, dosage, and duration), pharmacokinetic parameters (clearance, volume of distribution, elimination rate constant, and half-life), analytic methodology, pharmacokinetic model, and blood sampling times. The United States Preventive Services Task Force rating scale was used to categorize the 50 pertinent citations identified in our literature search. According to the rating scale, 12 studies were level I (prospective, randomized, controlled studies), 3 were level II-1 (prospective, nonrandomized, controlled studies), 30 were level II-2 (prospective, nonrandomized, uncontrolled [cohort] studies), and 5 were level III (case reports or descriptive studies). CONCLUSION: The pharmacokinetics of IGIV shows considerable intra- and interpopulation variability among patients with normal immunoglobulin levels, patients with primary immunodeficiency diseases, bone marrow transplant recipients, patients with immune deficiency due to chronic lymphocytic leukemia or multiple myeloma, very low birth weight neonates, neonates with suspected sepsis, high-risk infants in the neonatal intensive care unit, high-risk infants with cardiopulmonary disease, children with cryptogenic West or Lennox-Gastaut syndrome, women and infants with fetal alloimmune thrombocytopenia, and women with recurrent spontaneous abortions. Despite the large number of studies characterizing the pharmacokinetics of IGIV, major literature gaps include lack of information on IGIV clearance or area under the curve parameters and target serum immunoglobulin G concentrations. Further study is needed to rigorously characterize the pharmacokinetic properties of IGIV in a range of patient populations.
Authors: Emily A Holmes; Debra L Friedman; James A Connelly; Daniel E Dulek; Zhiguo Zhao; Adam J Esbenshade Journal: J Pediatr Hematol Oncol Date: 2019-08 Impact factor: 1.289
Authors: Carla S Walti; Elizabeth M Krantz; Joyce Maalouf; Jim Boonyaratanakornkit; Jacob Keane-Candib; Laurel Joncas-Schronce; Terry Stevens-Ayers; Sayan Dasgupta; Justin J Taylor; Alexandre V Hirayama; Merav Bar; Rebecca A Gardner; Andrew J Cowan; Damian J Green; Michael J Boeckh; David G Maloney; Cameron J Turtle; Joshua A Hill Journal: JCI Insight Date: 2021-06-08