It can cause serious blood conditions, seizures, and heart problems
The US Food and Drug Administration requires patients in the United States to have a minimum absolute neutrophil count (ANC) greater than or equal to 1500/microL to initiate clozapine [ 1 ]
6 month metabolic labs only recommended for children and adolescents Beyond 1 year, obtain annual metabolic labs; more frequently if abnormal
The ANC is the laboratory blood test required for monitoring patients on clozapine ANC unit of measure: cells per cubic millimeter (cmm = cu mm = mm3 = μL) VistA requires a matching WBC result from the same draw date/time The clozapine REMS is a safety program required by the FDA to manage the risk of severe neutropenia associated with clozapine treatment; it was originally instituted in September 2015
Do not use a gel-barrier tube
A REMS is a strategy to manage known or potential risks associated with a drug or group of drugs and is required by the Food and Drug Administration (FDA) for clozapine to ensure that the benefits of the drug outweigh the risk of severe neutropenia
Feel like you have the flu
Patient Information (Clozapine Tablets) 25 mg and 100 mg Antipsychotic Agent Novartis Pharmaceuticals Canada Inc
5 There was a significant difference wherein patients taking clozapine had a median transit time of 104
Severe neutropenia (absolute neutrophil count (ANC) less than 500/µL), can lead to serious and fatal infections
900 mg per day, if restarting after interval of more than 48 hours, 12
Clozapine causes metabolic problems, such as weight gain, type two diabetes and blood sugar problems, high blood pressure, and raised cholesterol
gov, 1-855-543-3784 or 301-796-3400
Be sure to keep all CYP2D6 poor metabolizers: Clozapine dose reduction may be needed; Significant renal or hepatic impairment: Clozapine dose reduction may be needed; Dosing Considerations
To help avoid these problems, drink lots of noncaffeine liquids unless told to drink less liquid by your doctor
It has been associated with agranulocytosis Initial dose: 12
pains in the stomach, side, or abdomen, possibly radiating to the back
swelling of the body or feet and ankles
The baseline Clozapine-induced myocarditis is a hypersensitivity reaction that usually occurs in the third week of clozapine therapy and about 2% of clozapine patients
You can find detailed information about this drug in the official Patient Information Leaflet (PIL)
You should not stop using clozapine suddenly
This agent became available on the European market for the treatment of schizophrenia with the promise of a better tolerability because of the absence of those extrapyramidal side effects that afflicted patients treated with other antipsychotic agents (e
Use Caution/Monitor
As of October 12, 2015, all previous clozapine registries were replaced by a single, shared centralized system called the Clozapine REMS program
Clozapine is superior to other antipsychotics as a therapy for treatment-resistant schizophrenia and schizoaffective disorder with increased risk of suicidal behavior
1
Unlike traditional anti-psychotic agents, such as chlorpromazine and Clozapine was the first atypical antipsychotic approved for treatment of schizophrenia
5
Skin reactions: people taking antipsychotics may be more sensitive to sunlight
Clozapine is the most effective antipsychotic for patients with treatment-refractory schizophrenia, providing clear benefits in about 60% of subjects [1-3]
Clozapine is not the first-line drug of choice due to its range of adverse effects, making compliance an issue for many patients
Includes CloZAPine indications, dosage/administration, pharmacology, mechanism/onset/duration of action, half-life, dosage forms, interactions, warnings, adverse reactions, off-label uses and more
How much drug you take may need to be changed
But clozapine's most serious risk is for neutropenia (low white blood cell count)
Orthostatic Hypotension, Bradycardia, and Syncope: Risk is dose- related
The objective of this review is to provide an overview and guide for clinicians and researchers on clozapine initiation, and to propose a practical checklist for patient selection, clozapine initiation (titration) and maintenance, side-effect monitoring and
The
The ANC is the laboratory blood test required for monitoring patients on
single shared program called the Clozapine Risk Evaluation and Mitigation Strategy
[Updated 12/2/2021] Health care professionals continue to alert FDA about
Clozapine is an atypical antipsychotic that is used for treatment-resistant schizophrenia
There is a different monitoring protocol for patients who have been diagnosed with Benign Ethnic Neutropenia (BEN)
sticking out of the tongue
It is also known by the trade names Clozaril, Denzapine and Zaponex
While you are taking clozapine, your blood may need to be tested every week for the first 6 months of treatment
Rash, fever, and swollen lymph nodes
Follow guidelines for appropriate next steps according to the patient's lab results
You should not stop using clozapine suddenly
This agent became available on the European market for the treatment of schizophrenia with the promise of a better tolerability because of the absence of those extrapyramidal side effects that afflicted patients treated with other
Clozapine was first discovered in 1959 by scientists at Wander Laboratories, who were screening tricyclic compounds for anti-depressant activity and were surprised to discover drugs with a chemical structure comparable to the tricyclic anti-depressants but with antipsychotic properties (Naheed & Green, 2001)
You will be told how to do this by your clinic
Clozapine is almost completely metabolized prior to excretion, and only trace amounts of unchanged drug are detected in the urine and feces
hhs
Clozapine was noted to differ from other antipsychotics available at that time because it produced fewer extrapyramidal symptoms (EPS); it was also reported to have marked analgesic potential
This side effect occurs in less than 1 out of every 100 people who take this medicine
Skin reactions: people taking antipsychotics may be more sensitive to sunlight