title: Pharmacokinetics of 8 mg/kg anti-human T-lymphocyte rabbit immunoglobulin conditioning for hematopoietic stem cell transplantation in Japanese patients.
abstract: Anti-human T-lymphocyte immunoglobulin, rabbit (ATG, Zetbulin(®) intravenous infusion liquid), is an immunosuppressive agent that is indicated for aplastic anemia in Japan. The "prevention of graft-versus-host disease (GVHD) for allogeneic hematopoietic stem cell transplantation in adults" indication has been added to ATG in 32 countries worldwide, but has not yet been approved for GVHD prevention in Japan. The pharmacokinetics of ATG in Japanese people has not yet been assessed. In this study, to assess ATG pharmacokinetics, ATG (2 mg/kg/day from day-4 to day-1) as a pretransplant treatment was administered to six patients who had received transplantation of HLA-haploidentical stem cells. The ATG concentration was measured using an ELISA kit for rabbit IgG. The serum ATG concentration increased with administration for 4 consecutive days, peaking at a concentration of 66.0 μg/ml (±8.8 SD). Subsequently, it gradually decreased with an elimination half-life of 21.9 days (±20.4 SD) but was still detectable in serum even a few weeks after allogeneic hematopoietic stem cell transplantation. We found the pharmacokinetics of ATG in this study to be comparable to those described in previous reports from Europe.
authors.affiliation: Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine.
authors.forename: Katsuji
authors.initials: K
authors.lastname: Kaida
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Ikegame
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Suzuki
authors.forename: Youji
authors.initials: Y
authors.lastname: Shibayama
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Ogawa
mesh_terms: D000818:Animals; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage / Q000494:pharmacology*; D007564:Japan; D007938:Leukemia / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011817:Rabbits; D013601:T-Lymphocytes / Q000276:immunology*; D019172:Transplantation Conditioning; D055815:Young Adult
chemical_list: D007136:Immunoglobulins