BZP – Benzodiazepines

Clinical Background

Benzodiazepines are a group of psychoactive drugs with a broad range of therapeutic effects. They act as anxiolytics, sedatives and anticonvulsants and belong to the most frequently prescribed drugs all over the world. Currently around 50 different benzodiazepines are globally marketed. The chemical structure the drugs differ in pharmacokinetics and metabolic properties. Long-term administration of benzodiazepines requires therapeutic drug monitoring (TDM).

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested. The RECIPE analytical method provides the reliable quantitation of 35 different benzodiazepines.

Analytes

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BZP – Benzodiazepines in Serum/Plasma Technote
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ADP – Antidepressants

Clinical background

Many adults are affected by major depressive disorders (MDD) at some point during their lifetime. Treatment for MDD is often started in a primary care setting, and patients generally receive drugs as the standard treatment. In addition to the classical tricyclic antidepressants (TCAs) a variety of newer antidepressants (ADP) is available for the treatment of MDD. These include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs, NRIs) as well as tetracyclic antidepressants (TeCAs).

Therapeutic drug monitoring (TDM), i.e. the quantification of serum concentrations of medications for dose optimization, is required to ensure a patient-matched psychopharmacotherapy and to avoid side effects. Uncertain drug adherence, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful.

Analytes

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AED – Antiepileptic Drugs

Clinical Background

Epilepsy is a chronic neurological disorder, characterised by recurrent epileptic seizures. The frequency and the rhythm of seizures are hardly predictable. Therefore, seizures are not only a considerable psychological and physical burden for the patient, they may also lead to grave and even life-threatening hurts (e.g. craniocerebral injuries in case of falls). Brain damages may result in case of a hypoxia. Today, a variety of antiepileptic drugs (AEDs) with different pharmacological properties is available.

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested. The RECIPE analytical method provides the reliable quantification of 27 AEDs.

Analytes

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AED – Antiepileptic Drugs in Serum/Plasma
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AMC – Antimycotics

Clinical Background

Invasive fungal infections, predominantly aspergillosis and candidiasis, are the most important causes of morbidity and mortality in immunocompromised patients. Primarily patients with acute leukemia undergoing myelosuppressive chemotherapy and allogeneic stem cell transplant recipients are affected. Up to 60 % of patients with invasive aspergillosis, the most common invasive mycosis among patients with hematologic malignancies, may still die of their infection, once it has become clinically overt.

Antimycotics (antifungal drugs, antifungals) are a class of drugs that are used for the treatment and prophylaxis of fungal infections.

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested.

The RECIPE analytical method provides the reliable quantification of 8 antimycotics.

Analytes

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AMC – Antimycotics in Serum/Plasma
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MPA – Mycophenolic Acid

Clinical background

Mycophenolic acid (MPA) is the active metabolite of the prodrug mycophenolate mofetil (MMF, proprietary names CellCept and Myfortic) and is used for the immunosuppressive therapy in patients who are undergoing solid organ transplantation. MPA is widely used along with other standard drug regimens such as with tacrolimus, cyclosporine and/or corticosteroids to ensure that graft rejection does not occur.

Following oral MMF administration, MPA is rapidly absorbed and distributed in blood and tissues. MPA peak concentrations usually are observed within an hour. In the liver MPA is metabolised whereby the phenolic glucuronide MPAG (mycophenolic acid glucuronide) forms the main fraction:

MMF → MPA → MPAG

MPAG is pharmacologically inactive. However, MPA may be reformed from MPAG by entero-hepatic recirculation (EHR). As a result secondary MPA plasma peaks are frequently observed (6-12h post oral dose) even after the absorption from the oral dose has ceased to exist.

The clinical pharmacokinetics of MPA are characterized by a high inter- and intraindividual variability. Reasons for interindividual pharmacokinetic variability include differences in albumin concentrations, bilirubin and hemoglobin concentrations, renal and hepatic function (impairment), co-administration of cyclosporine, comorbidities such as cystic fibrosis, body weight, exposure to concomitant medication, time after transplantation, gender, race, and genetic polymorphisms in drug-metabolising enzymes.

The administration of MMF therefore requires a therapeutic drug monitoring (TDM) in order to provide an optimal therapeutic efficacy, i.e. to maximise drug efficacy while minimising drug toxicity and is strongly recommended in pediatric transplantation patients.

Although a global consensus on TDM has not been established for MPA, there has been a suggestion of maintaining MPA threshold levels in a 12h dosing interval to achieve an AUC for MPA of approximately 30–60 mg × h/l for an effective prophylaxis. RECIPE´s analytical method ensures the quantification of MPA and MPAG and provides an adequate chromatographic separation of both analytes. Besides the monitoring of secondary MPA an adequate separation ensures to avoid false positive MPA values caused by ion-source fragmentation of MPAG.

Analytes

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NLP – Neuroleptics

Clinical background

Neuroleptics belong to the class of psychoactive drugs and are administered in the therapy of psychoses, in particular the symptomatic treatment of schizophrenia. The longterm administration of neuroleptics gradually reduces schizophrenic reactions such us split personality, hallucinations, delusional ideas, and as a consequence the patient’s level of suffering is decreased.

Neuroleptics are classified in different substance groups such as phenothiazines, butyrophenones, dibenzazepines and so called “atypical” neuroleptics. All neuroleptics have in common that the acute onset effect correlates with the current blood-level concentration. Higher dosages lead to apathy and sleep, the acute intoxication (e.g. by suicidal intent) results in delirium, coma and even death due to circulatory failure and respiratory paralysis. Therapeutic drug monitoring (TDM) is recommended for treatment with neuroleptics.

TDM is the quantification of the drug concentration in serum. It is carried out in order to find the optimal drug level for the patient and thus to ensure the best psychoactive drug therapy for the patient with the lowest possible amount of side effects. Uncertain drug adherences, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful. The RECIPE analytical method provides the reliable quantification of 28 different neuroleptics.

Analytes

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TCA – Tricyclic Antidepressants

Clinical background

Tricyclic antidepressants (TCAs) are a group of psychoactive drugs which are mainly used for the therapy of endogene depressions, anxiety and pain management. Their name is derived from a common chemical structure with a tripartite ring system. The following figure exemplifies the structure with the compounds amitryptiline, imipramine, doxepin and clomipramine.

TCAs are widely established compounds since the 1960s, however due to their side effects they have a narrow therapeutic range, which requires therapeutic drug monitoring (TDM). The consequences of overdosing may vary from mild agitation or drowsiness to delirium and coma resulting in death.

The drug monitoring is mainly performed from serum. Besides dosage optimisation, the monitoring is used for the verification of compliance as well as for the early detection of pharmacokinetic changes of the compound.

RECIPE’s analytical method provides the reliable quantification of 13 TCAs and two atypical neuroleptics and their metabolites.

Analytes

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ISD – Immunosuppressants

Clinical background

Immunosuppressive drugs have an inhibitory effect on the immune system. They are used in organ transplantations with the aim of suppressing immune reactions of the recipient. Therefore a regular monitoring of the drug concentration in blood is necessary.

Common drug classes are the selective immunosuppressants sirolimus, everolimus and mycophenolic acid as well as the calcineurin inhibitors cyclosporine A and tacrolimus. All of those drugs have a narrow therapeutic range, so underdosing leads to rejection of the transplanted organ and overdosing to life-threatening, toxic side effects. By using the RECIPE TDM 200 Kit System for measuring immunosuppressant blood concentrations on a regular basis, the ideal target concentration of the drugs can be achieved. The Immunosuppressants Add-on Set includes the four most common drugs cyclosporine A, sirolimus, everolimus and tacrolimus.

Analytes

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ABx – Antibiotics

Clinical Background

Antibiotics are chemotherapeutic agents that have a bactericidal (bacteria-killing) or bacteriostatic (growth –inhibiting) effect.

RECIPE offers a universal ClinMass® TDM platform (order no. MS9000), which can be used with various ClinMass® Add-on Sets (ClinMass® TDM Kit System).

The ClinMass® Add-on Set with order no. MS9700 contains the analyte -specific components for the determination of 15 different antibiotics. The analysis is performed by HPLC coupled with tandem mass spectrometry (LC-MS/MS).

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ABx – Antibiotics in Serum/Plasma
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