Psychotrope Medication 2 LC-MS

Intended Use
This Psychotropic Medication 2 kit is intended for the determination of seven (7) antipsychotic medications (several of which can be referred to as neuroleptics) in serum, conducted by laboratory professionals on LC-MS/MS.

Summary
Therapeutic Drug Monitoring (TDM) is based on the assumption that there is a relationship between the blood concentration and clinical effect (therapeutic improvement and adverse effects). It also assumes there is a concentration range of the drug which is characterized by maximal effectiveness and maximal safety, the “therapeutic window”(2). The Diagnotix kit for measuring antipsychotics includes aripiprazole, olanzapine, risperidone (including the metabolite 9-OH-risperidone, also paliperidone), quetiapine, haloperidol, and clozapine.

The antipsychotics are used for the treatment of schizophrenia and schizoaffective disorder, moderate to severe manic episodes, bipolar disorder, treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia, psychosis during the course of Parkinson's disease, acute treatment of delirium, treatment of tic disorders including Tourette's syndrome, and treatment of mild to moderate chorea in Huntington’s disease.

The antipsychotic drugs have a pronounced inter-individual pharmacokinetic variability and a narrow therapeutic window. Studies on the relation between blood concentration and clinical improvement have supported this relation for the antipsychotic drugs. TDM of aripiprazole, risperidone, and quetiapine is therefore recommended in the consensus guidelines for TDM in Psychiatry. TDM will increase the probability of response in non-responders. At subtherapeutic drug concentrations, there is a risk of poor response and at supratherapeutic drug concentrations, there is an increased risk of intolerance or intoxication. TDM of clozapine, olanzapine, and haloperidol is strongly recommended in the consensus guidelines for TDM in Psychiatry. At drug concentrations within the reported therapeutic reference range, the highest probability of response or remission can be expected. At subtherapeutic drug concentrations in blood, the response rate is similar to placebo under acute treatment, and there is a risk of relapse under chronic treatment. At supratherapeutic drug concentrations in blood, there is an increased risk of adverse drug reactions or outright toxicity.

TDM is therefore (strongly) recommended for dose titration at the start of the treatment and for special indications, such as in patients with therapeutic failure, adverse events, drug-drug interactions, relevant comorbidities such as patients with altered hepatic and/or renal clearance, presence of an infection, or patients who start or stop smoking, patients with altered CYP2D6, CYP1A2, CYP3A4, or CYP2C19 metabolic activity, and if nonadherence is suspected. Reference concentrations are based on literature and an overview of target concentrations can be found in several articles and in the consensus guidelines for TDM in Psychiatry(1).

TDM of clozapine is also advised in the Summary of Product Characteristics (SPC) in clinical situations, such as when a patient ceases smoking (altered metabolism of clozapine can lead to altered clozapine exposure), when concomitant drugs may interact and increase or decrease clozapine blood concentration, where poor clozapine metabolism is suspected, when a patient has pneumonia or other serious infection (altered metabolism of clozapine can lead to altered clozapine exposure), and in the event of onset of symptoms suggestive of toxicity (adverse events)(6). Furthermore, a high inter-patient pharmacokinetic variability of clozapine is seen(1). This pharmacokinetic variability, in combination with a good correlation between clozapine blood concentrations and efficacy/toxicity makes TDM also useful at the start of clozapine treatment for dose titration, in case of an insufficient response to the treatment, in case of suspected non-adherence, and with the use of high clozapine doses.

Manufactured by Diagnotix; Distributed by Tecan, IBL International GmbH.

For concrete data please consult the Instruction for Use in the download box on the top right side.

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