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Article ; Online: Question: How Should I Monitor and Adjust the Clozapine Dose for My Patients Who Develop COVID and Could Benefit From Nirmatrelvir/Ritonavir?

de Leon, Jose

2024 Volume 44, Issue 2, Page(s) 201–203

MeSH term(s)	Humans ; Ritonavir ; Clozapine/adverse effects ; COVID-19 ; COVID-19 Drug Treatment ; Lactams ; Leucine ; Nitriles ; Proline
Chemical Substances	nirmatrelvir (7R9A5P7H32) ; Ritonavir (O3J8G9O825) ; Clozapine (J60AR2IKIC) ; Lactams ; Leucine (GMW67QNF9C) ; Nitriles ; Proline (9DLQ4CIU6V)
Language	English
Publishing date	2024-02-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	604631-9
ISSN	1533-712X ; 0271-0749
ISSN (online)	1533-712X
ISSN	0271-0749
DOI	10.1097/JCP.0000000000001828
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Zs.A 1664: Show issues

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Article ; Online: Promoting safer and wider worldwide use of clozapine.

de Leon, Jose

Schizophrenia research

2024

Abstract: This issue focuses on the past, the present and the future of clozapine. Of the 43 clozapine articles, nine are historical articles dealing with the past, 29 deal with the present and five with laboratory assays which may influence its future use. These ... ...

Abstract	This issue focuses on the past, the present and the future of clozapine. Of the 43 clozapine articles, nine are historical articles dealing with the past, 29 deal with the present and five with laboratory assays which may influence its future use. These 43 articles include 219 different authors from 56 countries/regions and five continents.
Language	English
Publishing date	2024-03-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	639422-x
ISSN	1573-2509 ; 0920-9964
ISSN (online)	1573-2509
ISSN	0920-9964
DOI	10.1016/j.schres.2024.03.003
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Zs.A 2351: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 543: Show issues

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Article ; Online: Can Slow Personalized Titration Using C-Reactive Protein Monitoring Decrease the High Rates and Mortality of Clozapine-Associated Myocarditis Seen in Some Countries? A Call for Research.

de Leon, Jose

Journal of clinical psychopharmacology

2024 Volume 44, Issue 3, Page(s) 212–219

Abstract: Purpose/background: The hypothesis that slower personalized titration may prevent clozapine-associated myocarditis and decrease the disproportion incidence of 3% found in Australia was not described in a recent Australian article in this journal.: ... ...

Abstract	Purpose/background: The hypothesis that slower personalized titration may prevent clozapine-associated myocarditis and decrease the disproportion incidence of 3% found in Australia was not described in a recent Australian article in this journal. Methods: Six countries in addition to Australia have published information suggesting a similar incidence of clozapine-associated myocarditis. On September 19, 2023, PubMed searches were updated for articles from the United States, Korea, Japan, Canada, New Zealand, and Turkey. Findings/results: An incidence of 3.5% (4/76) was found in a US hospital, but US experts were the first to propose that clozapine-associated myocarditis may be a hypersensitivity reaction associated with rapid titration and possibly preventable. Koreans and Japanese are of Asian ancestry and need lower minimum therapeutic doses for clozapine than patients of European ancestry. A 0.1% (2/1408) incidence of myocarditis during clozapine titration was found in a Korean hospital, but pneumonia incidence was 3.7% (52/1408). In 7 Japanese hospitals, 34% (37/110) of cases of clozapine-associated inflammation were found during faster titrations (based on the official Japanese titration) versus 13% (17/131) during slower titrations (based on the international titration guideline for average Asian patients). Recent limited studies from Canada, New Zealand, and Turkey suggest that slower personalized titration considering ancestry may help prevent clozapine-associated myocarditis. Implications/conclusions: Other countries have very limited published data on clozapine-associated myocarditis. Based on a recent Australian case series and these non-Australian studies, the author proposes that Australia (and other countries) should use slow personalized titration for clozapine based on ancestry and c-reactive protein monitoring.
MeSH term(s)	Humans ; Clozapine/adverse effects ; Clozapine/administration & dosage ; Myocarditis/chemically induced ; Myocarditis/epidemiology ; C-Reactive Protein/metabolism ; Antipsychotic Agents/adverse effects ; Antipsychotic Agents/administration & dosage ; Incidence ; Australia ; Canada/epidemiology ; Japan ; New Zealand/epidemiology ; United States/epidemiology ; Turkey ; Schizophrenia/drug therapy ; Drug Monitoring/methods ; Precision Medicine ; Republic of Korea
Chemical Substances	Clozapine (J60AR2IKIC) ; C-Reactive Protein (9007-41-4) ; Antipsychotic Agents
Language	English
Publishing date	2024-03-28
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	604631-9
ISSN	1533-712X ; 0271-0749
ISSN (online)	1533-712X
ISSN	0271-0749
DOI	10.1097/JCP.0000000000001843
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Zs.A 1664: Show issues

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Book: A practitioner's guide to prescribing antiepileptics and mood stabilizers for adults with intellectual disabilities

De Leon, Jose

2012

Author's details	Jose de Leon, ed
Keywords	Anticonvulsants--Therapeutic use. ; Drugs--Prescribing ; People with mental disabilities--Medical care
Subject code	615.7840874
Language	English
Size	XXXI, 507 S. : Ill., 24 cm
Publisher	Springer
Publishing place	New York u.a.
Publishing country	United States
Document type	Book
HBZ-ID	HT017185594
ISBN	978-1-4614-2011-8 ; 1-4614-2011-3 ; 9781461420125 ; 1461420121
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Shelf mark	Loan status	Location
2012 A 1269	order for loan	Magazin

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Article: An international clozapine titration guideline for clozapine: An opportunity for moving forward on personalizing clozapine treatment in India and other countries.

de Leon, Jose

Indian journal of psychiatry

2022 Volume 64, Issue 4, Page(s) 331–334

Language	English
Publishing date	2022-07-13
Publishing country	India
Document type	Editorial
ZDB-ID	221523-8
ISSN	0019-5545
ISSN	0019-5545
DOI	10.4103/indianjpsychiatry.indianjpsychiatry_423_22
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Zs.B 2038: Show issues

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Article: Reflections on the Lack of Consideration of Ethnic Ancestry to Stratify Clozapine Dosing.

de Leon, Jose

Psychiatry investigation

2023 Volume 20, Issue 3, Page(s) 183–195

Abstract: This review article argues against trusting standard clozapine references, including the US package insert, because they do not include advances in the sciences of pharmacokinetics and pharmacovigilance and ignore the effects of ethnic ancestry on ... ...

Abstract	This review article argues against trusting standard clozapine references, including the US package insert, because they do not include advances in the sciences of pharmacokinetics and pharmacovigilance and ignore the effects of ethnic ancestry on therapeutic dosing. The minimum therapeutic dose leading to the minimum therapeutic concentration of 350 ng/mL in serum/plasma can be used to compare individuals/groups with treatment-resistant schizophrenia. The US clozapine package insert recommends targeting doses of 300-450 mg/day and, subsequently, increments of up to 100 mg with a maximum dose of 900 mg/day. Ethnic ancestry is defined by DNA ancestry group. Asians (people with ancestry ranging from Pakistan to Japan) and Indigenous Americans are similar in clozapine dosing; their average clozapine minimum therapeutic dose ranged from 166 mg/day (female non-smokers) to 270 mg/day (male smokers). For those with European ancestry, average clozapine minimum therapeutic doses ranged from 236 mg/day (female non-smokers) to 368 mg/day (male smokers). Based on limited studies, Black (African sub-Saharan ancestry) patients may be treated with typical US doses (300-600 mg/day), assuming no poor metabolism (PM) status. Ancestry's impact on clozapine lethality in four countries is discussed (two countries with highly homogenous populations, Denmark and Japan, and two countries with increasingly heterogenous populations due to immigration, Australia and the UK). An international guideline with 104 authors from 50 countries/regions was recently published, providing 6 personalized clozapine titration schedules for adult inpatients (3 ancestry groups and PM/non-PM schedules) and recommending c-reactive protein monitoring at baseline and weekly for 4 weeks.
Language	English
Publishing date	2023-02-28
Publishing country	Korea (South)
Document type	Journal Article
ZDB-ID	2414364-9
ISSN	1976-3026 ; 1738-3684
ISSN (online)	1976-3026
ISSN	1738-3684
DOI	10.30773/pi.2022.0293
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Zs.A 6598: Show issues

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Article ; Online: The history of clozapine in clinical practice: From its introduction to a guideline proposing personalized titrations.

de Leon, Jose

Journal of psychopharmacology (Oxford, England)

2022 Volume 36, Issue 6, Page(s) 657–660

MeSH term(s)	Antipsychotic Agents/adverse effects ; Clozapine/adverse effects
Chemical Substances	Antipsychotic Agents ; Clozapine (J60AR2IKIC)
Language	English
Publishing date	2022-05-01
Publishing country	United States
Document type	Editorial
ZDB-ID	639313-5
ISSN	1461-7285 ; 0269-8811
ISSN (online)	1461-7285
ISSN	0269-8811
DOI	10.1177/02698811221101059
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Zs.A 2311: Show issues

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Article ; Online: According to the WHO clozapine pharmacovigilance database, the United Kingdom accounts for 968 fatal outcomes versus 892 in the rest of the world.

de Leon, Jose

British journal of clinical pharmacology

2022 Volume 88, Issue 12, Page(s) 5434–5435

MeSH term(s)	Humans ; Clozapine/adverse effects ; Pharmacovigilance ; Antipsychotic Agents/adverse effects ; World Health Organization ; Adverse Drug Reaction Reporting Systems
Chemical Substances	Clozapine (J60AR2IKIC) ; Antipsychotic Agents
Language	English
Publishing date	2022-09-15
Publishing country	England
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15522
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Zs.A 1118: Show issues

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Article: Reflections on the Complex History of the Concept of Clozapine-Induced Inflammation during Titration.

de Leon, Jose

Psychiatria Danubina

2022 Volume 34, Issue 3, Page(s) 411–421

Abstract: Clozapine was synthesized in 1958. The Food and Drug Administration approved it in 1989 when comprehensive pharmacokinetic studies were not required and it was not known that clozapine was metabolized by the cytochrome P450 1A2 (CYP1A2). Currently it is ... ...

Abstract	Clozapine was synthesized in 1958. The Food and Drug Administration approved it in 1989 when comprehensive pharmacokinetic studies were not required and it was not known that clozapine was metabolized by the cytochrome P450 1A2 (CYP1A2). Currently it is known that clozapine personalized dosing may be influenced by one's DNA ancestry (African, European and/or Asian/Indigenous American), sex/smoking subgroup, and the presence/absence of genetic/non-genetic poor metabolizer (PM) status. The literature does not properly reflect the concept of "clozapine-induced inflammation" during rapid titration. Elaborating upon this concept, this historical review discusses: 1) clozapine-induced fever, 2) the effects of inflammation on clozapine metabolism, 3) clozapine-induced myocarditis, 4) other clozapine-induced inflammations, 4) current support for "clozapine-induced inflammation" as a hypersensitivity reaction, 5) the difficulty in addressing such a concept to a readership with diverse beliefs about it and 6) the limitations of this review in convincing skeptics. Clozapine-induced fever in the absence of any concomitant infection was first described in 1972 and is a mild form of "clozapine-induced inflammation" during rapid titration, which also includes myocarditis and other localized inflammations. They may be part of a hypersensitivity reaction that has 3 phases. In the first phase, the titration is too fast for a specific patient; either the psychiatrist was too aggressive in titrating, and/or the patient is a clozapine PM. This situation leads to a release of cytokines. In the second phase, a positive feedback loop develops; the cytokines inhibit CYP1A2, which further increases plasma clozapine concentrations. In the third phase, if the titration continues, the inflammation becomes complicated by the development of an auto-immune phenomenon leading to localized inflammation. Skeptical readers are challenged to try: 1) 6 titrations proposed for stratified dosing and 2) c-reactive protein (CRP) monitoring for personalized dosing in the absence of genetic testing for clozapine PM status.
MeSH term(s)	Humans ; Clozapine/adverse effects ; Cytochrome P-450 CYP1A2/metabolism ; Antipsychotic Agents/adverse effects ; Myocarditis/chemically induced ; C-Reactive Protein ; Inflammation/chemically induced ; Cytokines
Chemical Substances	Clozapine (J60AR2IKIC) ; Cytochrome P-450 CYP1A2 (EC 1.14.14.1) ; Antipsychotic Agents ; C-Reactive Protein (9007-41-4) ; Cytokines
Language	English
Publishing date	2022-05-12
Publishing country	Croatia
Document type	Review ; Journal Article
ZDB-ID	1067580-2
ISSN	0353-5053
ISSN	0353-5053
DOI	10.24869/psyd.2022.411
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Zs.A 3158: Show issues

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Article ; Online: Precision psychiatry: The complexity of personalizing antipsychotic dosing.

de Leon, Jose

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

2022 Volume 58, Page(s) 80–85

Abstract: Recently, Salagre and Vieta commented on the complexity of implementing precision medicine in psychiatry. For 25 years, this author has focused on a circumscribed type of precision medicine: personalized dosing using pharmacokinetic mechanisms to ... ...

Abstract	Recently, Salagre and Vieta commented on the complexity of implementing precision medicine in psychiatry. For 25 years, this author has focused on a circumscribed type of precision medicine: personalized dosing using pharmacokinetic mechanisms to stratified patients. This short communication focuses on personalized dosing of three oral antipsychotics (clozapine, risperidone and paliperidone) and presents their maintenance dosing in a table which provides dose-correction factors generated by pharmacokinetic studies. Inhibitors need dose-correction factors < 1 and inducers need correction factors >1. Clozapine maintenance dosing is based on the dose needed to reach 350 ng/ml (the minimum plasma therapeutic concentration in treatment-resistant schizophrenia). Clozapine maintenance dosing is influenced by 3 levels of complexity: 1) ancestry groups (Asians/Native Americans; Europeans and Blacks), 2) sex-smoking subgroups (lowest dose in female non-smokers and highest in male smokers) and 3) presence/absence of poor metabolizer status (due to genetic and non-genetic causes including co-prescription of inhibitors, obesity or inflammation). Risperidone and paliperidone maintenance dosing are based on the dose needed to reach plasma concentrations of 20-60 ng/ml. Risperidone PMs need approximately half the dose, which can be explained by genetics (CYP2D6 PMs) or co-prescription of CYP2D6 inhibitors. Fluoxetine co-prescription may require one fourth the risperidone maintenance dose. Carbamazepine co-prescription may require twice the risperidone maintenance dose. Although not well studied, two groups may need higher doses of oral paliperidone: Koreans may need 1.5 times higher doses while those taking carbamazepine may need 3 times higher paliperidone maintenance doses. Precision dosing in psychiatry requires using blood levels of individuals.
MeSH term(s)	Antipsychotic Agents ; Benzodiazepines/therapeutic use ; Carbamazepine ; Clozapine ; Female ; Humans ; Male ; Paliperidone Palmitate/therapeutic use ; Psychiatry ; Risperidone/therapeutic use
Chemical Substances	Antipsychotic Agents ; Benzodiazepines (12794-10-4) ; Carbamazepine (33CM23913M) ; Clozapine (J60AR2IKIC) ; Risperidone (L6UH7ZF8HC) ; Paliperidone Palmitate (R8P8USM8FR)
Language	English
Publishing date	2022-03-18
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1082947-7
ISSN	1873-7862 ; 0924-977X
ISSN (online)	1873-7862
ISSN	0924-977X
DOI	10.1016/j.euroneuro.2022.03.001
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Zs.A 3288: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 630: Show issues

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