An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels

. 2022 Mar ; 55 (2) : 73-86. [epub] 20211215

Jazyk angličtina Země Německo Médium print-electronic

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid34911124

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.

3rd Department of Psychiatry Division of Neurosciences School of Medicine Faculty of Health Sciences Aristotle University of Thessaloniki Greece

Addictions Division Centre for Addiction and Mental Health Toronto Canada

Biomedical Research Centre in Mental Health Net Santiago Apostol Hospital University of the Basque Country Vitoria Spain

British Columbia Mental Health and Substance Use Research Institute Department of Psychiatry University of British Columbia Vancouver BC Canada

Cambridge Psychosis Centre Cambrigeshire and Peterborough NHS Foundation Trust and Department of Psychiatry University of Cambridge Cambridge United Kingdom

Casa de Salidedo Som Jesus Oporto Portugal

Center for Drug Sciences Faculty of Pharmacy University of Medicine and Pharmacy Carol Davila Bucharest Romania

Center for Psychopharmacology Diakonhjemmet Hospital Oslo Norway

Center for Research and Innovation in Clinical Pharmaceutical Sciences Lausanne University Hospital and University of Lausanne Switzerland

Central Institute of Mental Health Department of Molecular Neuroimaging Medical Faculty Mannheim University of Heidelberg Mannheim Germany

Centre for Quality Management of Medicines Faculty of Pharmacy Universiti Kebangsaan Malaysia Kuala Lumpur Malaysia

Charité Universitätsmedizin Berlin Department of Child and Adolescent Psychiatry Berlin Germany

Clinical Pharmacology Unit and Outpatient Clinic Vilardebó Hospital Administración de Servicios de Salud Montevideo Uruguay

Clinical Pharmacology Unit and Pharmacy Department Vilardebó Hospital Administración de Servicios de Salud Montevideo Uruguay

College of Pharmacy QU Health Qatar University Doha Qatar

Department and Institute of Psychiatry and Mental Health Oporto Faculty of Medicine Oporto Portugal

Department and Institute of Psychiatry University of São Paulo Medical School Sao Paulo Brazil

Department for Psychiatry and Psychological Medicine University Hospital Center Zagreb Croatia

Department of Affective Disorders Aarhus University Hospital Psychiatry Aarhus Denmark

Department of Clinical and Experimental Medicine University of Messina Messina Italy

Department of Clinical Medicine Aarhus University Aarhus Denmark

Department of Clinical Pharmacology Astrakhan State Medical University Astrakhan Russian Federation

Department of Internal Medicine Dermatology and Psychiatry School of Medicine and Instituto Universitario de Neurociencia University of La Laguna Canary Islands Spain

Department of Neuropsychiatry Keio University School of Medicine Tokyo Japan

Department of Neuropsychiatry Nowon Eulji Medical Center Eulji University School of Medicine Seoul Korea

Department of Neurosciences Jerez University Hospital Andalusian Health Service University of Cadiz Jerez Spain

Department of Pharmacy Hôpital du Sacré Cœur de Montréal Montreal Canada

Department of Pharmacy Mayo Clinic Rochester MN USA

Department of Pharmacy Practice University of Montana Missoula USA

Department of Physical Medicine and Pharmacology School of Medicine Universidad de La Laguna Canary Islands Spain

Department of Physiology Los Andes University Medical School Mérida Venezuela

Department of Psychiatry and Behavioral Sciences Emory University School of Medicine Atlanta Georgia USA

Department of Psychiatry and Brain Disease Research Center China Medical University Hospital Taichung Taiwan

Department of Psychiatry and Clinical Psychology Northern State Medical University Arkhangelsk Russia

Department of Psychiatry and Mental Health University of Cape Town Valkenberg Hospital Western Cape Cape Town South Africa

Department of Psychiatry and Molecular Medicine Donald and Barbara Zucker School of Medicine at Hofstra Northwell Hempstead New York USA

Department of Psychiatry and Psychotherapy University Medical Center of Mainz Germany

Department of Psychiatry Asahi General Hospital Chiba Japan

Department of Psychiatry Autonomous University of Barcelona Spain

Department of Psychiatry Beijing Anding Hospital Capital Medical University Beijing China

Department of Psychiatry Charles University 3rd Faculty of Medicine Prague Czech Republic

Department of Psychiatry Christian Medical College Vellore India

Department of Psychiatry Complejo Hospitalario Universitario de Santiago Santiago de Compostela Spain

Department of Psychiatry Hacettepe University Faculty of Medicine Ankara Turkey

Department of Psychiatry Hamad Medical Corporation Doha Qatar

Department of Psychiatry Linkou Chang Gung Memorial Hospital Taoyuan Taiwan

Department of Psychiatry LSK Faculty of Medicine The University of Hong Kong Hong Kong SAR

Department of Psychiatry Massachusetts General Hospital Harvard Medical School Boston MA USA

Department of Psychiatry Medical University of Gdańsk Gdańsk Poland

Department of Psychiatry Okayama Psychiatric Medical Center Okayama Japan

Department of Psychiatry Post Graduate Institute of Medical Education and Research Chandigarh India

Department of Psychiatry Psychotherapy and Psychosomatics Psychiatric Hospital University of Zürich Zürich Switzerland

Department of Psychiatry Queens University Kingston Canada

Department of Psychiatry Sackler Faculty of Medicine and Sagol School of Neuroscience Tel Aviv University Tel Aviv Israel

Department of Psychiatry Satasairaala Finland

Department of Psychiatry School of Medicine Maryland Psychiatric Research Center University of Maryland School of Medicine Baltimore Maryland USA

Department of Psychiatry School of Medicine Pontificia Universidad Católica de Chile Santiago Chile

Department of Psychiatry School of Medicine Taipei Medical University Taipei Taiwan

Department of Psychiatry School of Medicine University Hospital Virgen del Rocio IBIS Sevilla Spain

Department of Psychiatry School of Medicine University of Zagreb Zagreb Croatia

Department of Psychiatry Seoul National University Hospital Seoul National University College of Medicine Seoul Republic of Korea

Department of Psychiatry Tampere University Hospital Tampere Finland

Department of Psychiatry The University of Melbourne Melbourne Victoria Australia

Department of Psychiatry University Medical Centre Maribor Maribor Slovenia

Department of Psychiatry University of Kentucky Lexington KY USA

Department of Psychiatry University of Toronto Toronto Ontario Canada

Department of Psychiatry Washington University in St Louis St Louis Missouri USA

Department of Psychological Medicine University of Otago Wellington New Zealand

Department of Psychology College of Medical and Health Sciences Asia University Taichung Taiwan

Departments of Medical Genetics Psychiatry Physiology and Pharmacology and Community Health Sciences University of Calgary Alberta Canada

Division of Clinical Pharmacology Department of Medicine Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South Africa

Dutch Clozapine Collaboration Group Castricum The Netherlands

East London NHS Foundation Trust London United Kingdom

Eastern State Hospital Lexington Kentucky USA

FACT team in Heerhugowaard Department of Severe Mental Illness Mental Health Services North Holland North The Netherlands

Faculdade de Medicina da Universidade do Porto Porto Portugal

Facultad de Química Universidad Nacional Autónoma de México México City México

Faculty of Medicine and Health Technology Tampere University Tampere Finland

Faculty of Medicine University of Montreal Montreal Canada

Faculty of Medicine University of Sfax Sfax Tunisia

Federal Neuropsychiatric Hospital Yaba Lagos Nigeria

Graduate Institute of Biomedical Sciences China Medical University Taichung Taiwan

Group of Resistant Schizophrenia Federal University of Sao Paulo SP Brazil

Grupo de Investigación en Psiquiatría GIPSI Departamento de Psiquiatría Facultad de Medicina Universidad de Antioquia Medellin Colombia

Hazelwood Center Louisville Kentucky USA

Honorary Clinical Senior Lecturer Barts and the London School of Medicine Queen Mary University of London United Kingdom

Hospital Central de Maputo Maputo Mozambique

Hospital Universitario Central de Asturias Oviedo Spain

Hospital Universitario de Canarias Tenerife Spain

Hospital Valle del Nalón Langreo Spain

Institute of Mental Health Jubilee Campus University of Nottingham Triumph Road Nottingham United Kingdom

Institute of Neuropsychiatry and Addictions Parc de Salut Mar Barcelona Spain

Institute of Pharmaceutical Sciences of Western Switzerland University of Geneva University of Lausanne Switzerland

Instituto Nacional de Neurología y Neurocirugía México City México

Instituto Vilapriño Center for Studies Assistance and Research in Neurosciences Mendoza Argentina

INUBE Biosanitary Research Institute of Extremadura Extremadura University Hospital and Medical School Badajoz Spain

Laboratory of Clinical Psychopharmacology Beijing Anding Hospital Capital Medical University Beijing China

Mental Health Centre Glostrup Copenhagen University Hospital Copenhagen Denmark

Mental Health Research Center Eastern State Hospital Lexington KY USA

Mental Health Team Alkmaar Mental Health Services Noord Holland Noord Alkmaar The Netherlands

Metro South Addiction and Mental Health Service Brisbane Australia

National Institute of Mental Health Klecany Czech Republic

National Institute of Mental Health Neurology and Neurosurgery Budapest Hungary

New York Medical College Department of Psychiatry and Behavioral Sciences Valhalla NY USA

NHS Department of Mental Health G Mazzini Hospital Teramo Italy

Programa Trastornos del Ánimo Hospital Universitario San Vicente Fundación Medellín Colombia

Psychiatry A Department Hedi Chaker University Hospital Sfax Tunisia

Psychiatry and Neurosciences Research Group Institute of Neurosciences University of Granada Granada Spain

Psychiatry Department Centro Hospitalar Universitário de S João Porto Portugal

Queensland Centre for Mental Health Research and School of Clinical Medicine University of Queensland Brisbane Australia

Research Unit Geha Mental Health Center and Molecular Psychiatry Laboratory Felsenstein Medical Research Center Tel Aviv Israel

School of Medicine Keele University Staffordshire and Midlands Partnership NHS Foundation Trust Staffordshire United Kingdom

School of Medicine Virginia Commonwealth University Richmond VA USA

School of Pharmaceutical Sciences University of Geneva Switzerland

Secretaría de Salud Mental y Adicciones Ministerio de Salud de la Provincia de Jujuy San Salvador de Jujuy Argentina

Section for Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Oslo Norway

Semel Institute for Neuroscience at UCLA Los Angeles CA USA

Sigmund Freud University Vienna Austria

Spanish Network for Research in Mental Health Instituto de Salud Carlos 3 Madrid Spain

Spanish Network for Research in Mental Health Sevilla Spain

State Key Laboratory of Brain and Cognitive Sciences The University of Hong Kong Hong Kong SAR

Substance Abuse Treatment Program Atlanta VA Medical Center Decatur Georgia USA

Te Korowai Whāriki Central Regional Forensic Service Capital and Coast District Health Board Wellington New Zealand

The National Clinical Research Centre for Mental Disorders and Beijing Key Lab of Mental Disorders Beijing Anding Hospital Capital Medical University Beijing China

The Zucker Hillside Hospital Psychiatry Research Northwell Health Glen Oaks New York USA

Unit of Pharmacogenetics and Clinical Psychopharmacology Center for Psychiatric Neurosciences Lausanne University Hospital and University of Lausanne Switzerland

Univ Bordeaux Inserm Bordeaux Population Health Research Center Team Pharmacoepidemiology UMR 1219 F 33000 Bordeaux France

Universidad de Oviedo CIBERSAM INEUROPA ISPA FIMBA Oviedo Spain

University of Kragujevac Faculty of Medical Sciences Department of Psychiatry Kragujevac Serbia

VA Desert Pacific Mental Illness Research Education and Clinical Center Los Angeles CA USA

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