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José de León, Georgios Schoretsanitis, Robert L. Smith, Espen Molden, Anssi Solismaa, Niko Seppälä, Miloslav Kopeček, Patrik Švancer, Ismael Olmos, Carina Ricciardi and 94 more
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.
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León, J. D., Schoretsanitis, G., Smith, R. L., Molden, E., Solismaa, A., Seppälä, N., Kopeček, M., Švancer, P., Olmos, I., Ricciardi, C., García, C. I., Iglesias-Alonso, A., Spina, E., Ruan, C., Wang, C., Wang, G., Tang, Y., Lin, S., Lane, H., … Müller, D. J. (2021). An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels. Pharmacopsychiatry, 55(02), 73–86. https://doi.org/10.1055/a-1625-6388
León, José de, et al. "An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels." Pharmacopsychiatry, vol. 55, no. 02, 2021, pp. 73–86, https://doi.org/10.1055/a-1625-6388.
León, José de, Georgios Schoretsanitis, Robert L. Smith, Espen Molden, Anssi Solismaa, Niko Seppälä, Miloslav Kopeček, et al. "An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels." Pharmacopsychiatry 55, no. 02 (2021): 73–86. https://doi.org/10.1055/a-1625-6388.
León J. D., Schoretsanitis G., Smith R. L. [и др.] An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels // Pharmacopsychiatry. — 2021. — Vol. 55, № 02. — P. 73–86. — URL: https://doi.org/10.1055/a-1625-6388
@article{leon2021international,
title = {{An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels}},
author = {José de León and Georgios Schoretsanitis and Robert L. Smith and Espen Molden and Anssi Solismaa and Niko Seppälä and Miloslav Kopeček and Patrik Švancer and Ismael Olmos and Carina Ricciardi and Celso Iglesias García and Ana Iglesias-Alonso and Edoardo Spina and Can‐Jun Ruan and Chuanyue Wang and Gang Wang and Yi‐lang Tang and Shih‐Ku Lin and Hsien‐Yuan Lane and Yong Sik Kim and Se Hyun Kim and Anto Praveen Rajkumar and Dinora F. González‐Esquivel and Helgi Helene Jung-Cook and Trino Baptista and Christopher Rohde and Jimmi Nielsen and Hélène Verdoux and Clélia Quilès and Emílio J. Sanz and Carlos De las Cuevas and Dan Cohen and Peter F.J. Schulte and Aygün Ertuğrul and Ayşe Elif Anil Yağcioğlu and Nitin Chopra and Betsy McCollum and Charles I. Shelton and Robert O. Cotes and Arun R. Kaithi and John Michael Kane and Saeed Farooq and Chee H. Ng and John Bilbily and Christoph Hiemke and Carlos López‐Jaramillo and Ian R. McGrane and Fernando Lana and Chin B. Eap and Manuel Arrojo and Flavian Ștefan Rădulescu and Erich Seifritz and Susanna Every‐Palmer and Chad Bousman and Emmanuel Bebawi and Rahul Bhattacharya and Deanna L. Kelly and Yuji Otsuka and Judit Lazáry and Rafael Torres and Agustín Yécora and Mariano Motuca and Sherry Kit Wa Chan and Monica Zolezzi and Sami Ouanes and Domenico De Berardis and Sandeep Grover and Ric M. Procyshyn and Richard A. Adebayo and Oleg O. Kirilochev and Andrey G. Soloviev and Konstantinos Ν. Fountoulakis and Alina Wilkowska and Wiesław Jerzy Cubała and Muhammad Ayub and Alzira Silva and Raphael M. Bonelli and José María Villagrán Moreno and Benedicto Crespo‐Facorro and Henk S. Temmingh and Eric H. Decloedt and Maria Rosel Pedro and Hiroyoshi Takeuchi and Masaru Tsukahara and Gerhard Gründer and Marina Šagud and Andreja Čelofiga and Dragana Ignjatović Ristić and Bruno Bertolucci Ortiz and Hélio Elkis and António José Pacheco Palha and Adrián LLerena and Emilio Fernández-Egea and Dan J. Siskind and Abraham Weizman and Rim Masmoudi and Shamin Mohd Saffian and Jonathan G. Leung and P.F. Buckley and Stephen R. Marder and Leslie Citrome and Oliver Freudenreich and Christoph Ulrich Correll and Daniel J. Müller},
journal = {Pharmacopsychiatry},
year = {2021},
volume = {55},
number = {02},
pages = {73--86},
doi = {10.1055/a-1625-6388},
url = {https://doi.org/10.1055/a-1625-6388}
}TY - JOUR AU - León, José de AU - Schoretsanitis, Georgios AU - Smith, Robert L. AU - Molden, Espen AU - Solismaa, Anssi AU - Seppälä, Niko AU - Kopeček, Miloslav AU - Švancer, Patrik AU - Olmos, Ismael AU - Ricciardi, Carina AU - García, Celso Iglesias AU - Iglesias-Alonso, Ana AU - Spina, Edoardo AU - Ruan, Can‐Jun AU - Wang, Chuanyue 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 Praveen AU - González‐Esquivel, Dinora F. AU - Jung-Cook, Helgi Helene AU - Baptista, Trino AU - Rohde, Christopher AU - Nielsen, Jimmi AU - Verdoux, Hélène AU - Quilès, Clélia AU - Sanz, Emílio J. AU - Cuevas, Carlos De las AU - Cohen, Dan AU - Schulte, Peter F.J. AU - Ertuğrul, Aygün AU - Yağcioğlu, Ayşe Elif Anil AU - Chopra, Nitin AU - McCollum, Betsy AU - Shelton, Charles I. AU - Cotes, Robert O. AU - Kaithi, Arun R. AU - Kane, John Michael AU - Farooq, Saeed AU - Ng, Chee H. AU - Bilbily, John AU - Hiemke, Christoph AU - López‐Jaramillo, Carlos AU - McGrane, Ian R. AU - Lana, Fernando AU - Eap, Chin B. AU - Arrojo, Manuel AU - Rădulescu, Flavian Ștefan AU - Seifritz, Erich AU - Every‐Palmer, Susanna AU - Bousman, Chad AU - Bebawi, Emmanuel AU - Bhattacharya, Rahul AU - Kelly, Deanna L. AU - Otsuka, Yuji AU - Lazáry, Judit AU - Torres, Rafael AU - Yécora, Agustín AU - Motuca, Mariano AU - Chan, Sherry Kit Wa AU - Zolezzi, Monica AU - Ouanes, Sami AU - Berardis, Domenico De AU - Grover, Sandeep AU - Procyshyn, Ric M. AU - Adebayo, Richard A. AU - Kirilochev, Oleg O. AU - Soloviev, Andrey G. AU - Fountoulakis, Konstantinos Ν. AU - Wilkowska, Alina AU - Cubała, Wiesław Jerzy AU - Ayub, Muhammad AU - Silva, Alzira AU - Bonelli, Raphael M. AU - Moreno, José María Villagrán AU - Crespo‐Facorro, Benedicto AU - Temmingh, Henk S. AU - Decloedt, Eric H. AU - Pedro, Maria Rosel AU - Takeuchi, Hiroyoshi AU - Tsukahara, Masaru AU - Gründer, Gerhard AU - Šagud, Marina AU - Čelofiga, Andreja AU - Ristić, Dragana Ignjatović AU - Ortiz, Bruno Bertolucci AU - Elkis, Hélio AU - Palha, António José Pacheco AU - LLerena, Adrián AU - Fernández-Egea, Emilio AU - Siskind, Dan J. AU - Weizman, Abraham AU - Masmoudi, Rim AU - Saffian, Shamin Mohd AU - Leung, Jonathan G. AU - Buckley, P.F. AU - Marder, Stephen R. AU - Citrome, Leslie AU - Freudenreich, Oliver AU - Correll, Christoph Ulrich AU - Müller, Daniel J. TI - An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels JO - Pharmacopsychiatry VL - 55 IS - 02 SP - 73 EP - 86 PY - 2021 DA - 2021/12/15 DO - 10.1055/a-1625-6388 UR - https://doi.org/10.1055/a-1625-6388 ER -
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