Pharmacokinetics for once-daily modified release formulation of tacrolimus hydrate in unrelated hematopoietic stem cell transplantation
A once-daily modified release formulation of oral tacrolimus (Tac QD) has been developed in response to the problem of nonadherence. However, there have been no data available about the efficacy of Tac QD conversion from intravenous Tac (Tac i.v.) in allogeneic hematopoietic stem cell transplantatio...
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Veröffentlicht in: | Annals of hematology 2015-03, Vol.94 (3), p.491-496 |
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creator | Yano, Shingo Mori, Shinichiro Saito, Takeshi Yokoyama, Hiroki Machishima, Tomohito Shimada, Takaki Yahagi, Yuichi Sugiyama, Katsuki Ogasawara, Yoji Takahara, Shinobu Kasama, Kinuyo Katsube, Atsushi Kamiyama, Yutaro Suzuki, Kazuhito Inui, Yumiko Usui, Noriko Aiba, Keisuke Yamashita, Takuya |
description | A once-daily modified release formulation of oral tacrolimus (Tac QD) has been developed in response to the problem of nonadherence. However, there have been no data available about the efficacy of Tac QD conversion from intravenous Tac (Tac i.v.) in allogeneic hematopoietic stem cell transplantation (allo-SCT). We analyzed the pharmacokinetics (PK) of Tac QD in allo-SCT recipients. A total of 10 patients with hematological malignancies who received allo-SCT from unrelated donors were enrolled. Patients received Tac i.v. at 0.03 mg/kg a day before transplantation. Administration of Tac i.v. was converted to Tac QD at a 1:4 ratio when the patients had recovered from regimen-related gastrointestinal toxicity and could tolerate oral medication. After conversion, six out of 10 patients (60 %) showed a sustained decrease in Tac exposure and required dose adjustment. The conversion from Tac i.v. to Tac QD should be performed under close medical supervision. Area under the curve (AUC) and the trough of Tac QD showed a correlation, and the trough should be maintained above 7.5 ng/ml to provide an adequate AUC. Although four patients received bone marrow from an HLA DRB1 1 antigen-mismatched unrelated donor, no patients developed grade III–IV acute graft-versus-host disease (GVHD). The modification of Tac QD to maintain a whole-blood trough concentration above 7.5 ng/ml may be as effective as Tac BID. |
doi_str_mv | 10.1007/s00277-014-2233-7 |
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However, there have been no data available about the efficacy of Tac QD conversion from intravenous Tac (Tac i.v.) in allogeneic hematopoietic stem cell transplantation (allo-SCT). We analyzed the pharmacokinetics (PK) of Tac QD in allo-SCT recipients. A total of 10 patients with hematological malignancies who received allo-SCT from unrelated donors were enrolled. Patients received Tac i.v. at 0.03 mg/kg a day before transplantation. Administration of Tac i.v. was converted to Tac QD at a 1:4 ratio when the patients had recovered from regimen-related gastrointestinal toxicity and could tolerate oral medication. After conversion, six out of 10 patients (60 %) showed a sustained decrease in Tac exposure and required dose adjustment. The conversion from Tac i.v. to Tac QD should be performed under close medical supervision. Area under the curve (AUC) and the trough of Tac QD showed a correlation, and the trough should be maintained above 7.5 ng/ml to provide an adequate AUC. Although four patients received bone marrow from an HLA DRB1 1 antigen-mismatched unrelated donor, no patients developed grade III–IV acute graft-versus-host disease (GVHD). The modification of Tac QD to maintain a whole-blood trough concentration above 7.5 ng/ml may be as effective as Tac BID.</description><identifier>ISSN: 0939-5555</identifier><identifier>EISSN: 1432-0584</identifier><identifier>DOI: 10.1007/s00277-014-2233-7</identifier><identifier>PMID: 25325985</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adult ; Aged ; Delayed-Action Preparations ; Drug Administration Schedule ; Female ; Hematology ; Hematopoietic Stem Cell Transplantation - methods ; Humans ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - pharmacokinetics ; Leukemia - metabolism ; Leukemia - therapy ; Lymphoma, Non-Hodgkin - metabolism ; Lymphoma, Non-Hodgkin - therapy ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Myelodysplastic Syndromes - metabolism ; Myelodysplastic Syndromes - therapy ; Oncology ; Original Article ; Tacrolimus - administration & dosage ; Tacrolimus - pharmacokinetics ; Transplantation Conditioning - methods ; Transplantation, Homologous ; Unrelated Donors ; Young Adult</subject><ispartof>Annals of hematology, 2015-03, Vol.94 (3), p.491-496</ispartof><rights>Springer-Verlag Berlin Heidelberg 2014</rights><rights>Springer-Verlag Berlin Heidelberg 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c508t-6d6be45e46451a38d4b5d02a3b1dcef76797edc9451d2a48c0d57be784d855fe3</citedby><cites>FETCH-LOGICAL-c508t-6d6be45e46451a38d4b5d02a3b1dcef76797edc9451d2a48c0d57be784d855fe3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00277-014-2233-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00277-014-2233-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25325985$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yano, Shingo</creatorcontrib><creatorcontrib>Mori, Shinichiro</creatorcontrib><creatorcontrib>Saito, Takeshi</creatorcontrib><creatorcontrib>Yokoyama, Hiroki</creatorcontrib><creatorcontrib>Machishima, Tomohito</creatorcontrib><creatorcontrib>Shimada, Takaki</creatorcontrib><creatorcontrib>Yahagi, Yuichi</creatorcontrib><creatorcontrib>Sugiyama, Katsuki</creatorcontrib><creatorcontrib>Ogasawara, Yoji</creatorcontrib><creatorcontrib>Takahara, Shinobu</creatorcontrib><creatorcontrib>Kasama, Kinuyo</creatorcontrib><creatorcontrib>Katsube, Atsushi</creatorcontrib><creatorcontrib>Kamiyama, Yutaro</creatorcontrib><creatorcontrib>Suzuki, Kazuhito</creatorcontrib><creatorcontrib>Inui, Yumiko</creatorcontrib><creatorcontrib>Usui, Noriko</creatorcontrib><creatorcontrib>Aiba, Keisuke</creatorcontrib><creatorcontrib>Yamashita, Takuya</creatorcontrib><title>Pharmacokinetics for once-daily modified release formulation of tacrolimus hydrate in unrelated hematopoietic stem cell transplantation</title><title>Annals of hematology</title><addtitle>Ann Hematol</addtitle><addtitle>Ann Hematol</addtitle><description>A once-daily modified release formulation of oral tacrolimus (Tac QD) has been developed in response to the problem of nonadherence. However, there have been no data available about the efficacy of Tac QD conversion from intravenous Tac (Tac i.v.) in allogeneic hematopoietic stem cell transplantation (allo-SCT). We analyzed the pharmacokinetics (PK) of Tac QD in allo-SCT recipients. A total of 10 patients with hematological malignancies who received allo-SCT from unrelated donors were enrolled. Patients received Tac i.v. at 0.03 mg/kg a day before transplantation. Administration of Tac i.v. was converted to Tac QD at a 1:4 ratio when the patients had recovered from regimen-related gastrointestinal toxicity and could tolerate oral medication. After conversion, six out of 10 patients (60 %) showed a sustained decrease in Tac exposure and required dose adjustment. The conversion from Tac i.v. to Tac QD should be performed under close medical supervision. Area under the curve (AUC) and the trough of Tac QD showed a correlation, and the trough should be maintained above 7.5 ng/ml to provide an adequate AUC. Although four patients received bone marrow from an HLA DRB1 1 antigen-mismatched unrelated donor, no patients developed grade III–IV acute graft-versus-host disease (GVHD). The modification of Tac QD to maintain a whole-blood trough concentration above 7.5 ng/ml may be as effective as Tac BID.</description><subject>Adult</subject><subject>Aged</subject><subject>Delayed-Action Preparations</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Hematology</subject><subject>Hematopoietic Stem Cell Transplantation - methods</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - pharmacokinetics</subject><subject>Leukemia - metabolism</subject><subject>Leukemia - therapy</subject><subject>Lymphoma, Non-Hodgkin - metabolism</subject><subject>Lymphoma, Non-Hodgkin - therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Myelodysplastic Syndromes - metabolism</subject><subject>Myelodysplastic Syndromes - therapy</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Tacrolimus - administration & dosage</subject><subject>Tacrolimus - pharmacokinetics</subject><subject>Transplantation Conditioning - methods</subject><subject>Transplantation, Homologous</subject><subject>Unrelated Donors</subject><subject>Young Adult</subject><issn>0939-5555</issn><issn>1432-0584</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kMuOFCEUhonROO2MD-DGkLhGuRbU0ky8JZPoYmZNKDhlM1ZBC9Sin2BeW9oejRvZQPJ_5zvhR-gVo28ZpfpdpZRrTSiThHMhiH6CdkwKTqgy8ina0VGMRPVzgV7Uek8p40by5-iCK8HVaNQOPXzbu7I6n3_EBC36iudccE4eSHBxOeI1hzhHCLjAAq7CKV-3xbWYE84zbs6XvMR1q3h_DMU1wDHhLXW8vwPew-paPuR4suPaYMUelgW34lI9LC6136or9Gx2S4WXj_cluvv44fb6M7n5-unL9fsb4hU1jQxhmEAqkINUzAkT5KQC5U5MLHiY9aBHDcGPPQ3cSeNpUHoCbWQwSs0gLtGbs_dQ8s8NarP3eSupr7RsUEwwOpqhU-xM9b_VWmC2hxJXV46WUXuq3p6rt716e6re6j7z-tG8TSuEvxN_uu4APwO1R-k7lH9W_9f6C72Tko0</recordid><startdate>20150301</startdate><enddate>20150301</enddate><creator>Yano, Shingo</creator><creator>Mori, Shinichiro</creator><creator>Saito, Takeshi</creator><creator>Yokoyama, Hiroki</creator><creator>Machishima, Tomohito</creator><creator>Shimada, Takaki</creator><creator>Yahagi, Yuichi</creator><creator>Sugiyama, Katsuki</creator><creator>Ogasawara, Yoji</creator><creator>Takahara, Shinobu</creator><creator>Kasama, Kinuyo</creator><creator>Katsube, Atsushi</creator><creator>Kamiyama, Yutaro</creator><creator>Suzuki, Kazuhito</creator><creator>Inui, Yumiko</creator><creator>Usui, Noriko</creator><creator>Aiba, Keisuke</creator><creator>Yamashita, Takuya</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20150301</creationdate><title>Pharmacokinetics for once-daily modified release formulation of tacrolimus hydrate in unrelated hematopoietic stem cell transplantation</title><author>Yano, Shingo ; Mori, Shinichiro ; Saito, Takeshi ; Yokoyama, Hiroki ; Machishima, Tomohito ; Shimada, Takaki ; Yahagi, Yuichi ; Sugiyama, Katsuki ; Ogasawara, Yoji ; Takahara, Shinobu ; Kasama, Kinuyo ; Katsube, Atsushi ; Kamiyama, Yutaro ; Suzuki, Kazuhito ; Inui, Yumiko ; Usui, Noriko ; Aiba, Keisuke ; Yamashita, Takuya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c508t-6d6be45e46451a38d4b5d02a3b1dcef76797edc9451d2a48c0d57be784d855fe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Delayed-Action Preparations</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Hematology</topic><topic>Hematopoietic Stem Cell Transplantation - methods</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - pharmacokinetics</topic><topic>Leukemia - metabolism</topic><topic>Leukemia - therapy</topic><topic>Lymphoma, Non-Hodgkin - metabolism</topic><topic>Lymphoma, Non-Hodgkin - therapy</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Myelodysplastic Syndromes - metabolism</topic><topic>Myelodysplastic Syndromes - therapy</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Tacrolimus - administration & dosage</topic><topic>Tacrolimus - pharmacokinetics</topic><topic>Transplantation Conditioning - methods</topic><topic>Transplantation, Homologous</topic><topic>Unrelated Donors</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yano, Shingo</creatorcontrib><creatorcontrib>Mori, Shinichiro</creatorcontrib><creatorcontrib>Saito, Takeshi</creatorcontrib><creatorcontrib>Yokoyama, Hiroki</creatorcontrib><creatorcontrib>Machishima, Tomohito</creatorcontrib><creatorcontrib>Shimada, Takaki</creatorcontrib><creatorcontrib>Yahagi, Yuichi</creatorcontrib><creatorcontrib>Sugiyama, Katsuki</creatorcontrib><creatorcontrib>Ogasawara, Yoji</creatorcontrib><creatorcontrib>Takahara, Shinobu</creatorcontrib><creatorcontrib>Kasama, Kinuyo</creatorcontrib><creatorcontrib>Katsube, Atsushi</creatorcontrib><creatorcontrib>Kamiyama, Yutaro</creatorcontrib><creatorcontrib>Suzuki, Kazuhito</creatorcontrib><creatorcontrib>Inui, Yumiko</creatorcontrib><creatorcontrib>Usui, Noriko</creatorcontrib><creatorcontrib>Aiba, Keisuke</creatorcontrib><creatorcontrib>Yamashita, Takuya</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Annals of hematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yano, Shingo</au><au>Mori, Shinichiro</au><au>Saito, Takeshi</au><au>Yokoyama, Hiroki</au><au>Machishima, Tomohito</au><au>Shimada, Takaki</au><au>Yahagi, Yuichi</au><au>Sugiyama, Katsuki</au><au>Ogasawara, Yoji</au><au>Takahara, Shinobu</au><au>Kasama, Kinuyo</au><au>Katsube, Atsushi</au><au>Kamiyama, Yutaro</au><au>Suzuki, Kazuhito</au><au>Inui, Yumiko</au><au>Usui, Noriko</au><au>Aiba, Keisuke</au><au>Yamashita, Takuya</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics for once-daily modified release formulation of tacrolimus hydrate in unrelated hematopoietic stem cell transplantation</atitle><jtitle>Annals of hematology</jtitle><stitle>Ann Hematol</stitle><addtitle>Ann Hematol</addtitle><date>2015-03-01</date><risdate>2015</risdate><volume>94</volume><issue>3</issue><spage>491</spage><epage>496</epage><pages>491-496</pages><issn>0939-5555</issn><eissn>1432-0584</eissn><abstract>A once-daily modified release formulation of oral tacrolimus (Tac QD) has been developed in response to the problem of nonadherence. However, there have been no data available about the efficacy of Tac QD conversion from intravenous Tac (Tac i.v.) in allogeneic hematopoietic stem cell transplantation (allo-SCT). We analyzed the pharmacokinetics (PK) of Tac QD in allo-SCT recipients. A total of 10 patients with hematological malignancies who received allo-SCT from unrelated donors were enrolled. Patients received Tac i.v. at 0.03 mg/kg a day before transplantation. Administration of Tac i.v. was converted to Tac QD at a 1:4 ratio when the patients had recovered from regimen-related gastrointestinal toxicity and could tolerate oral medication. After conversion, six out of 10 patients (60 %) showed a sustained decrease in Tac exposure and required dose adjustment. The conversion from Tac i.v. to Tac QD should be performed under close medical supervision. Area under the curve (AUC) and the trough of Tac QD showed a correlation, and the trough should be maintained above 7.5 ng/ml to provide an adequate AUC. Although four patients received bone marrow from an HLA DRB1 1 antigen-mismatched unrelated donor, no patients developed grade III–IV acute graft-versus-host disease (GVHD). The modification of Tac QD to maintain a whole-blood trough concentration above 7.5 ng/ml may be as effective as Tac BID.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>25325985</pmid><doi>10.1007/s00277-014-2233-7</doi><tpages>6</tpages></addata></record> |
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subjects | Adult Aged Delayed-Action Preparations Drug Administration Schedule Female Hematology Hematopoietic Stem Cell Transplantation - methods Humans Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - pharmacokinetics Leukemia - metabolism Leukemia - therapy Lymphoma, Non-Hodgkin - metabolism Lymphoma, Non-Hodgkin - therapy Male Medicine Medicine & Public Health Middle Aged Myelodysplastic Syndromes - metabolism Myelodysplastic Syndromes - therapy Oncology Original Article Tacrolimus - administration & dosage Tacrolimus - pharmacokinetics Transplantation Conditioning - methods Transplantation, Homologous Unrelated Donors Young Adult |
title | Pharmacokinetics for once-daily modified release formulation of tacrolimus hydrate in unrelated hematopoietic stem cell transplantation |
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