An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels
Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt
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An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels. / de Leon, Jose; Schoretsanitis, Georgios; Smith, Robert L.; Molden, Espen; Solismaa, Anssi; Seppala, Niko; Kopecek, Miloslav; Svancer, Patrik; Olmos, Ismael; Ricciardi, Carina; Iglesias-Garcia, Celso; Iglesias-Alonso, Ana; Spina, Edoardo; Ruan, Can-Jun; Wang, Chuan-Yue; Wang, Gang; Tang, Yi-Lang; Lin, Shih-Ku; Lane, Hsien-Yuan; Kim, Yong Sik; Kim, Se Hyun; Rajkumar, Anto P.; Gonzalez-Esquivel, Dinora F.; Jung-Cook, Helgi; Baptista, Trino; Rohde, Christopher; Nielsen, Jimmi; Verdoux, Helene; Quiles, Clelia; Sanz, Emilio J.; De las Cuevas, Carlos; Cohen, Dan; Schulte, Peter F. J.; Ertugrul, Aygun; Chopra, Nitin; McCollum, Betsy; Shelton, Charles; Cotes, Robert O.; Kaithi, Arun R.; Kane, John M.; Farooq, Saeed; Ng, Chee H.; Bilbily, John; Hiemke, Christoph; Lopez-Jaramillo, Carlos; McGrane, Ian; Lana, Fernando; Eap, Chin B.; Arrojo-Romero, Manuel; Seifritz, Erich; Every-Palmer, Susanna; Bousman, Chad A.; Bebawi, Emmanuel; Bhattacharya, Rahul; Kelly, Deanna L.; Otsuka, Yuji; Lazary, Judit; Torres, Rafael; Yecora, Agustin; Motuca, Mariano; Chan, Sherry K. W.; Zolezzi, Monica; Ouanes, Sami; De Berardis, Domenico; Grover, Sandeep; Procyshyn, Ric M.; Adebayo, Richard A.; Kirilochev, Oleg O.; Soloviev, Andrey; Fountoulakis, Konstantinos N.; Wilkowska, Alina; Ayub, Muhammad; Silva, Alzira; Bonelli, Raphael M.; Villagran-Moreno, Jose M.; Crespo-Facorro, Benedicto; Temmingh, Henk; Decloedt, Eric; Pedro, Maria R.; Takeuchi, Hiroyoshi; Tsukahara, Masaru; Gruender, Gerhard; Sagud, Marina; Celofiga, Andreja; Ristic, Dragana Ignjatovic; Ortiz, Bruno B.; Elkis, Helio; Palha, Antonio J. Pacheco; LLerena, Adrian; Fernandez-Egea, Emilio; Siskind, Dan; Weizman, Abraham; Masmoudi, Rim; Saffian, Shamin Mohd; Leung, Jonathan G.; Buckley, Peter F.; Marder, Stephen R.; Citrome, Leslie; Freudenreich, Oliver; Correll, Christoph U.; Muller, Daniel J.; Anil Yagcioglu, A. Elif; Radulescu, Flavian S.; Cubala, Wieslaw J.
I: Pharmacopsychiatry, Bind 55, Nr. 02, 03.2022, s. 73-86.Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt
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T1 - An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels
AU - de Leon, Jose
AU - Schoretsanitis, Georgios
AU - Smith, Robert L.
AU - Molden, Espen
AU - Solismaa, Anssi
AU - Seppala, Niko
AU - Kopecek, Miloslav
AU - Svancer, Patrik
AU - Olmos, Ismael
AU - Ricciardi, Carina
AU - Iglesias-Garcia, Celso
AU - Iglesias-Alonso, Ana
AU - Spina, Edoardo
AU - Ruan, Can-Jun
AU - Wang, Chuan-Yue
AU - Wang, Gang
AU - Tang, Yi-Lang
AU - Lin, Shih-Ku
AU - Lane, Hsien-Yuan
AU - Kim, Yong Sik
AU - Kim, Se Hyun
AU - Rajkumar, Anto P.
AU - Gonzalez-Esquivel, Dinora F.
AU - Jung-Cook, Helgi
AU - Baptista, Trino
AU - Rohde, Christopher
AU - Nielsen, Jimmi
AU - Verdoux, Helene
AU - Quiles, Clelia
AU - Sanz, Emilio J.
AU - De las Cuevas, Carlos
AU - Cohen, Dan
AU - Schulte, Peter F. J.
AU - Ertugrul, Aygun
AU - Chopra, Nitin
AU - McCollum, Betsy
AU - Shelton, Charles
AU - Cotes, Robert O.
AU - Kaithi, Arun R.
AU - Kane, John M.
AU - Farooq, Saeed
AU - Ng, Chee H.
AU - Bilbily, John
AU - Hiemke, Christoph
AU - Lopez-Jaramillo, Carlos
AU - McGrane, Ian
AU - Lana, Fernando
AU - Eap, Chin B.
AU - Arrojo-Romero, Manuel
AU - Seifritz, Erich
AU - Every-Palmer, Susanna
AU - Bousman, Chad A.
AU - Bebawi, Emmanuel
AU - Bhattacharya, Rahul
AU - Kelly, Deanna L.
AU - Otsuka, Yuji
AU - Lazary, Judit
AU - Torres, Rafael
AU - Yecora, Agustin
AU - Motuca, Mariano
AU - Chan, Sherry K. W.
AU - Zolezzi, Monica
AU - Ouanes, Sami
AU - De Berardis, Domenico
AU - Grover, Sandeep
AU - Procyshyn, Ric M.
AU - Adebayo, Richard A.
AU - Kirilochev, Oleg O.
AU - Soloviev, Andrey
AU - Fountoulakis, Konstantinos N.
AU - Wilkowska, Alina
AU - Ayub, Muhammad
AU - Silva, Alzira
AU - Bonelli, Raphael M.
AU - Villagran-Moreno, Jose M.
AU - Crespo-Facorro, Benedicto
AU - Temmingh, Henk
AU - Decloedt, Eric
AU - Pedro, Maria R.
AU - Takeuchi, Hiroyoshi
AU - Tsukahara, Masaru
AU - Gruender, Gerhard
AU - Sagud, Marina
AU - Celofiga, Andreja
AU - Ristic, Dragana Ignjatovic
AU - Ortiz, Bruno B.
AU - Elkis, Helio
AU - Palha, Antonio J. Pacheco
AU - LLerena, Adrian
AU - Fernandez-Egea, Emilio
AU - Siskind, Dan
AU - Weizman, Abraham
AU - Masmoudi, Rim
AU - Saffian, Shamin Mohd
AU - Leung, Jonathan G.
AU - Buckley, Peter F.
AU - Marder, Stephen R.
AU - Citrome, Leslie
AU - Freudenreich, Oliver
AU - Correll, Christoph U.
AU - Muller, Daniel J.
AU - Anil Yagcioglu, A. Elif
AU - Radulescu, Flavian S.
AU - Cubala, Wieslaw J.
PY - 2022/3
Y1 - 2022/3
N2 - This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas' original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300-600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75-150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175-300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100-200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250-400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150-300 mg/day, and 6) in the US with ancestries other than from Asia or the original people from the Americas with average clozapine metabolism needing 300-600 mg/day. Baseline and weekly CRP monitoring for at least four weeks is required to identify any inflammation, including inflammation secondary to clozapine rapid titration.
AB - This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas' original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300-600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75-150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175-300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100-200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250-400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150-300 mg/day, and 6) in the US with ancestries other than from Asia or the original people from the Americas with average clozapine metabolism needing 300-600 mg/day. Baseline and weekly CRP monitoring for at least four weeks is required to identify any inflammation, including inflammation secondary to clozapine rapid titration.
KW - Native American continental ancestry group
KW - Asian continental ancestry group
KW - clozapine/adverse effects
KW - clozapine/blood
KW - clozapine/metabolism
KW - clozapine/therapeutic use
KW - clozapine/toxicity
KW - drug labeling
KW - European continental ancestry group
KW - infection
KW - inflammation
KW - mortality/drug effects
KW - sex
KW - smoking
KW - TREATMENT-RESISTANT SCHIZOPHRENIA
KW - INDUCED MYOCARDITIS
KW - PLASMA-CONCENTRATIONS
KW - CYP1A2 ACTIVITY
KW - GENETIC POLYMORPHISMS
KW - DOSE TITRATION
KW - SERUM-LEVEL
KW - SMOKING
KW - PHARMACOKINETICS
KW - METABOLITES
U2 - 10.1055/a-1625-6388
DO - 10.1055/a-1625-6388
M3 - Review
C2 - 34911124
VL - 55
SP - 73
EP - 86
JO - Pharmacopsychiatry
JF - Pharmacopsychiatry
SN - 0176-3679
IS - 02
ER -
ID: 315543113