Clozapine Blood Level Testing by Immunoassay Clozapine Blood Level Testing by Immunoassay English summary Une production de l’Institut national d’excellence en santé et en services sociaux (INESSS) DECEMBER 2024 1 SUMMARY Clozapine Blood Level Testing by Immunoassay Introduction A request to introduce a new test into the Répertoire québécois et système de mesure des procédures de biologie an immunological assay in the Répertoire for the clozapine blood level testing used in the therapeutic follow-up of patients treated with this antipsychotic. Evaluation method The evaluation approach included a review of the scientific literature, a grey literature search and consultations with clinicians and other stakeholders. A review of the economic literature was conducted on the cost-effectiveness
Clinical considerations for patients prescribed clozapine Clinical considerations for patients prescribed clozapine – SPS - Specialist Pharmacy Service – The first stop for professional medicines advice SPS - Specialist Pharmacy Service The first stop for professional medicines advice * About * Log in * Register NHS * Guidance Guidance * Guidance index * PGDs * Administering * Cautions * Manufacturing and preparation * Unlicensed medicines * Homecare * ATMPs * Clinical Trials * Medical gases * Record keeping * More * Less * Home * Guidance * Medication Safety Clinical considerations for patients prescribed clozapine Published 28 June 2024 Topics: Clozapine · Medication Safety Healthcare professionals in all settings who interact with patients prescribed clozapine should be aware of clinical
Managing the risks associated with patients prescribed clozapine Managing the risks associated with patients prescribed clozapine – SPS - Specialist Pharmacy Service – The first stop for professional medicines advice SPS - Specialist Pharmacy Service The first stop for professional medicines advice * About * Log in * Register NHS * Guidance Guidance * Guidance index * PGDs * Administering * Manufacturing and preparation * Unlicensed medicines * Homecare * ATMPs * Clinical Trials * Medical gases * Record keeping * More * Less * Home * Guidance * Medication Safety Managing the risks associated with patients prescribed clozapine Published 28 June 2024 Topics: Clozapine · Medication Safety Healthcare professionals in non-specialist services managing patients prescribed clozapine should implement
Monitoring Patients With Psychotic Disorders for Clozapine-Induced Myocarditis or Cardiomyopathy Skip to main contentAboutCollaboration/OutreachPatient/CommunityCareersContactMy CADTHFRReportsResourcesProvide InputSubmit a RequestNews & EventsWhat Does The Evidence Say About...SearchBreadcrumbHome Monitoring Patients With Psychotic Disorders for Clozapine-Induced Myocarditis or CardiomyopathyCopied to clipboardMonitoring Patients With Psychotic Disorders for Clozapine-Induced Myocarditis or Cardiomyopathy( Last Updated : June 6, 2022)Project Line:Health Technology ReviewProject Sub Line:Rapid ReviewProject Number:RC1429-000DetailsQuestionWhat is the diagnostic accuracy of high-sensitivity troponin I testing versus troponin T testing for detecting myocarditis or cardiomyopathy in patients
Experiences of Blood Testing for the Management of Clozapine Skip to main contentAboutCollaboration/OutreachPatient/CommunityCareersContactMy CADTHFRReportsResourcesProvide InputSubmit a RequestNews & EventsWhat Does The Evidence Say About...SearchBreadcrumbHome Experiences of Blood Testing for the Management of ClozapineCopied to clipboardExperiences of Blood Testing for the Management of Clozapine( Last Updated : November 15, 2022)Project Status:CompletedProject Line:Reference ListProject Sub Line:Reference ListProject Number:RA1238-000Effective finish date:November 11, 2022DetailsQuestionWhat literature is available on the perspectives and experiences of people living (or caring for someone) with schizophrenia spectrum and other psychiatric disorders, and their health care providers
Clozapine use in adults with swallowing difficulties SPS - Specialist Pharmacy ServiceAbout Log in RegisterNHSGuidanceEventsPodcastsPlanningTrainingPublicationsTools SearchCOVID-19PGDsAdministeringCautions and contraindicationsDosingSwitchingMore Clozapine use in adults with swallowing difficultiesPublished 31 May 2023 · Last updated 12 June 2023 · See all updatesTopics: Clozapine · Mental health and illness · Primary Care and PCNs · Swallowing difficultiesGuidance on clozapine administration including crushing tablets, importance of not missing doses and practical considerations regarding switching formulationsThis article forms part of a seriesMedicines suitable for adults with swallowing difficultiesACEI and ARB suggestions for adults with swallowing difficultiesAnticoagulant suggestions
Polygenic overlap with granulocyte counts identifies novel loci for clozapine metabolism and clozapine-induced agranulocytosis. While clozapine is the most effective antipsychotic drug, its use is limited due to hematological adverse effects involving the reduction of granulocyte counts with potential life-threatening agranulocytosis. It is not yet possible to predict or prevent the risk of agranulocytosis, and the mechanisms are unknown but likely related to clozapine metabolism. Genome-wide association studies (GWASs) of clozapine metabolism and clozapine-induced agranulocytosis have identified few genetic loci. We used the largest available GWAS summary statistics of clozapine metabolism (clozapine-to-norclozapine ratio) and clozapine-induced agranulocytosis, applying the conditional false
Cross-titration from risperidone to clozapine utilizing clozapine serum concentrations: A case report. Clozapine and risperidone are second-generation antipsychotics used in the treatment of schizophrenia. There are no guidelines on cross-titration of antipsychotics and, additionally, there is a paucity of published data to support the potential utility of using serum drug levels to guide dosing in these situations. A 68-year-old female patient with a history of schizophrenia, taking risperidone and fluoxetine, and a recent diagnosis of Parkinson's disease was admitted to the hospital after a fall at home. During the patient's hospital stay, utilizing serum clozapine levels as guidance, the patient was cross-titrated from risperidone 12 mg daily to a final dose of clozapine 75 mg daily over the span of 17
Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I: A Review of the Pharmacokinetic Literature and Proposed Changes. Clozapine was approved in the United States (US) using 1989 regulations and knowledge. After 30 years, many sections of the US package insert (PI) are outdated. We comprehensively reviewed the literature to propose PI updates. We present the information in 2 articles. In Part I, we focus on basic pharmacology based on 407 relevant articles. Part II focuses on clinical aspects and pharmacovigilance. Based on more recent expectations of Food and Drug Administration regulations, we reviewed clozapine basic pharmacology including the following: 1) clearance, 2) pharmacokinetics and pharmacodynamics, and 3
Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part II: A Review of Fatal Outcomes in US Pharmacovigilance Data and Proposed Changes. This is the second part of a 2-part article that proposes improving the United States (US) clozapine package insert. Part II focuses on fatal outcomes and the 5 boxed warnings, 4 specifically for clozapine: severe neutropenia, seizure, orthostatic hypotension and myocarditis, and 1 for all antipsychotics (elderly with dementia). US reports to the World Health Organization's global pharmacovigilance database were analyzed from clozapine's introduction to January 15, 2023. The US was the top reporter worldwide for clozapine with 56,003 reports and 9587 associated fatal outcomes. The 4 clozapine
Weekly Changes in the Clozapine Concentration-to-Dose Ratio During Clozapine Titration in Japanese Patients With Schizophrenia. To prevent inflammatory side effects early in the titration phase of clozapine, international guidelines recommend measuring clozapine blood levels weekly. However, data on such measurements are lacking. We retrospectively reviewed the medical records of all patients with schizophrenia who were treated with clozapine for the first time and whose clozapine blood levels were measured for at least 2 consecutive weeks from clozapine initiation at our institution from 2020 to 2024. Patients were divided into 2 groups based on whether they had a fever during the first 6 weeks of clozapine treatment. The clozapine concentration-to-dose (C/D) ratios were compared weekly within 6 weeks
Managing constipation in people taking clozapine SPS - Specialist Pharmacy ServiceAbout Log in RegisterNHSGuidanceEventsPlanningTrainingPublications SearchCOVID-19PGDsAdministeringCautions and contraindicationsDosingMonitoringMore Managing constipation in people taking clozapineAmisha Gopal, Regional Medicines Information Pharmacist, London Medicines Information Service · Published 14 October 2022Topics: Cautions and contraindications · Clozapine · Mental health and illnessConstipation in people taking clozapine can be fatal. Guidance on preventing and managing constipation in these individuals is described.ContentsSafety concerns in practiceIntestinal obstruction, faecal impaction and paralytic ileusClozapine toxicityIncidence of constipationPreventing constipationCounsel people about
Predictors of clozapine concentration and psychiatric symptoms in patients with schizophrenia. Clozapine has superior efficacy to other antipsychotics, especially in patients with treatment-resistant schizophrenia. However, its pharmacokinetics and pharmacodynamics vary largely among patients. We aimed to evaluate the clinical and genetic factors associated with the pharmacokinetics and pharmacodynamics of clozapine in patients with schizophrenia. Blood samples for clozapine pharmacokinetic assessment were collected from patients with schizophrenia at weeks 2 (visit 2), 8 (visit 3), and 18 (visit 4) from the initiation of clozapine treatment. The Positive and Negative Syndrome Scale (PANSS) score was assessed at baseline (visit 1) and visits 3 and 4. Linear mixed models were used to identify
Assessment of treatment outcomes and associated factors among patients treated with clozapine at amanuel mental specialized hospital, Addis Ababa, Ethiopia. Clozapine is a medication used in psychiatry. It is the first atypical antipsychotic drug and the most effective in treatment resistant cases of schizophrenia and schizoaffective disorder. Studies also show benefits of clozapine in patients with tardive dyskinesia. However, there is scarcity of studies which show the outcome of clozapine treatment and factors associated with it in the Ethiopian context. The aim of the study was to assess treatment outcome and factors associated with it among patients treated with clozapine at Amanuel Mental Specialized Hospital Addis Ababa, Ethiopia. A hospital-based retrospective study, compounded by cross
CLEAR - clozapine in early psychosis: study protocol for a multi-centre, randomised controlled trial of clozapine vs other antipsychotics for young people with treatment resistant schizophrenia in real world settings. Clozapine is an antipsychotic drug with unique efficacy, and it is the only recommended treatment for treatment-resistant schizophrenia (TRS: failure to respond to at least two different antipsychotics). However, clozapine is also associated with a range of adverse effects which restrict its use, including blood dyscrasias, for which haematological monitoring is required. As treatment resistance is recognised earlier in the illness, the question of whether clozapine should be prescribed in children and young people is increasingly important. However, most research to date has
Effect of Coffee and Chocolate Ingestion on Clozapine Dose and on Plasma Clozapine and Norclozapine Concentrations in Clinical Practice. Some reports point to dietary caffeine intake as a cause of increased plasma clozapine concentrations in certain patients. We compared clozapine dose and plasma clozapine and N-desmethylclozapine (norclozapine) concentrations in male and female smokers and nonsmokers in relation to reported (i) coffee (caffeine) and (ii) chocolate (caffeine and theobromine) intake in samples submitted for clozapine therapeutic drug monitoring, 1993-2017. There was information on coffee ingestion for 16,558 samples (8833 patients) from males and 5886 samples (3433 patients) from females and on chocolate ingestion for 12,616 samples (7568 patients) from males and 4677 samples
Plasma Clozapine and N-Desmethylclozapine (Norclozapine) Concentrations and the Clozapine/Norclozapine Ratio: Effect of Dose, Sex, and Cigarette Smoking. Smoking enhances plasma clozapine clearance, but the magnitude of the effect across the dose and age ranges is unclear. We audited clozapine dose and predose plasma clozapine and N-desmethylclozapine (norclozapine) concentrations by sex and smoking habit in samples submitted for clozapine TDM, 1996-2017. There were 105,316/60,792 and 34,288/31,309 samples from male/female smokers/nonsmokers, respectively. There were distinct dose-median plasma concentration trajectories for male/female smokers/nonsmokers across the range <50 to >850 mg d-1. For both sexes, the percentage difference in median plasma clozapine in nonsmokers versus smokers
Clozapine Use Among People With Psychotic Disorders Who Experience Specific Indications for Clozapine. To examine rates of clozapine use among people with psychotic disorders who experience specific indications for clozapine. Records data from 11 integrated health systems identified patients aged 18 years or older with recorded , diagnoses of schizophrenia, schizoaffective disorder, or other psychotic disorder who experienced any of the 3 events between January 1, 2019, and December 31, 2019, suggesting indications for clozapine: a diagnosis of self-harm injury or poisoning, suicidal ideation diagnosed or in response to standardized assessments, and hospitalization or emergency department (ED) care for psychotic disorder despite treatment with 2 or more antipsychotic medications. Prescription
Electroconvulsive Therapy Versus Aripiprazole Addition to Clozapine in Patients with Clozapine-Resistant Symptoms (EMECLO): A Protocol of a Single-Blind, Multicenter, Randomized-Controlled Feasibility Trial. Currently, guidance on the most effective treatment for patients with clozapine-resistant schizophrenia-spectrum disorders (SSD) is lacking. While augmentation strategies to clozapine with aripiprazole and electroconvulsive therapy (ECT) have been demonstrated to be effective in patients with clozapine-resistant schizophrenia spectrum disorders (CRS), head-to-head comparisons between these addition strategies are unavailable. We therefore aim to examine the feasibility of a larger randomized, single-blind trial comparing the effectiveness, cost-effectiveness, and safety of aripiprazole
Exploring low clozapine C/D ratios, inverted clozapine-norclozapine ratios and undetectable concentrations as measures of non-adherence in clozapine patients: A literature review and a case series of 17 patients from 3 studies. Up to 1/2 of outpatients prescribed clozapine may be partially/fully non-adherent, based on therapeutic drug monitoring (TDM). Three indices for measuring partial/full non-adherence are proposed a: 1) clozapine concentration/dose (C/D) ratio which drops to half or more of what is expected in the patient; 2) clozapine/norclozapine ratio that becomes inverted; and 3) clozapine concentration that becomes non-detectable. These 3 proposed indices are based on a literature review and 17 cases of possible non-adherence from 3 samples: 1) an inpatient study in a Chinese