Atomoxetine - Stratterra

Extract from Product Insert Label

"Metabolism and elimination - Atomoxetine is metabolized primarily through the CYP2D6 enzymatic pathyway. People with reduced activity in this pathway (PMs) have higher plasma concentrations of atomoxetine compared with people with normal activity (EMs). For PMs, AUC of atomoxetine is approximately 10-fold and Css,max is about 5-fold greater than EMs. Laboratory tests are available to identify CYP2D6 PMs."

Source [lilly.com]

CYP2D6 Assay

Our CYP2D6 Molecular Assays consist in the detection of the principal variants responsible for abnormal metabolism status. These assays are ISO17025 accredited by BELAC and CLIA registered.

List of mutations analysed:

Variants

Alleles

Enzyme Activity

Gene duplication
Gene deletion
2549 A>del
1846 G>A
1707 T>del
2935 A>C
1758 G>T
2613-2615 AGA>del
100 C>T
883 G>C
124 G>A
1023 C>T + 2850 C>T

*XN
*5
*3
*4
*6
*7
*8
*9
*10

*11
*12
*17

Increased
Null
Null
Null
Null
Null
Null
Decreased
Decreased
Null
Null
Decreased

Phenotypic interpretation:

EM – IM – PM – UM

CYP2D6 phenotypes Prevalences in Caucasian

Extensive metabolizers (EM) represent the norm for metabolic capacity. Genotypes consistent with the EM phenotype include two active forms of the gene producing the drug metabolizing enzyme and therefore posses the full complement of drug metabolizing capacity. Generally, extensive metabolizers can be administered drugs which are substrates of the enzyme following standard dosing practices.

49%

Intermediate metabolizers (IM) may require lower than average drug dosages for optimal therapeutic response. In addition, multiple drug therapy should be monitored closely.

40%

Poor metabolizers (PM) are at increased risk of drug-induced side effects due to diminished drug elimination or lack of therapeutic effect resulting from failure to generate the active form of the drug. Genotypes consistent with the PM phenotype are those with no active genes producing the drug metabolizing enzyme. These individuals have a deficiency in drug metabolism.

10%

Ultra-extensive metabolizers (UM) may require an increased dosage due to higher than normal rates of drug metabolism. Simultaneously treating with medication that inhibits metabolization has also proven effective. Genotypes consistent with UM phenotype include three or more active genes producing the drug metabolizing enzyme and therefore have increased metabolic capacity.

1%

Laboratory Process

Specimen Requirements

These drugs have an information regarding importance of genetic variability contained in product labeling. We provide pharmacogenetic assays for the following drugs:

Turnaround Time

1 week

Report

A report will be generated including mutations that have been detected and in the case of mutants, the inferred metabolism status.

Prices and Ordering

Please inquire for prices and ordering information.