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Mechanism of Action

Selective estrogen receptor modulator: nonsteroid with potent antiestrogenic effects in breast (but may be estrogen agonist in uterus); has cytostatic effect rather than cytocidal effects (cells accumulate in Go and G1 phase of the cell cycle)

Pharmacokinetics

Half-Life: 7-14 hr

Peak Plasma Time: 3-6 hr

Protein binding: 99%

Peak Plasma Concentration: 40 ng/mL

Metabolism: by hepatic P450 enzyme CYP2C9,  CYP2D6, CYP3A4

Metabolites: N-desmethyl tamoxifen, endoxifen

Excretion: Feces (65%), urine (9%)

Pharmacogenomics

Metabolized via CYP2D6 into endoxifen (4-OH-N-desmethyl-tamoxifen), its primary active metabolite

Lowered CYP2D6 activity or gynecomastia concomitant CYP2D6 inhibitors may reduce tamoxifen efficacy

Poor CYP2D6 metabolizers are defined as those with 4/4 alleles

On October 18, 2006, the Pharmaceutical Science Clinical Pharmacology Subcommittee of the FDA recommended including information on CYP2D6 genotypes and their potential effect on patient outcomes in the label for tamoxifen, but they did not come to consensus on whether testing should be recommended or considered optional

Subsequent to that recommendation, branded tamoxifen (Nolvadex) was discontinued and no further guidance was given by FDA on whether to amend the label for generic tamoxifen

Recent data presented at the 2010 San Antonio Breast Cancer Symposium found the CYP2D6 allele status had no effect on any outcomes, including disease recurrence, distant recurrence, and overall survival

Further research will help elucidate the potential effect of strong CYP2D6 inhibitors, such as SSRIs, on tamoxifen metabolism, but there is no evidence to suggest that the use of such medications should influence the use of tamoxifen

Therefore, based on the data available to date, routine testing for CYP2D6 variants is not recommended

CYP2C19 heterozygous 2 carriership may be a predictive factor for patients with breast cancer nolvadex get rid gynecomastia treatment using tamoxifen; this factor was associated with a longer survival among tamoxifen users in a recent study (Pharmacogenomics. 2010;11[10]:1367-75)

Genetic testing laboratories

  • The Roche Cytochrome AmpliChip P450 2D6/2C19 Genotyping and Phenotyping Assay can be used to identify 26 different alleles of CYP2D6, including 4
  • The following companies offer testing for CYP2D6 variants
  • DxS (http://www.dxsdiagnostics.com/)
  • LabCorp (http://www.labcorp.com/)

Source: http://reference.medscape.com/drug/nolvadex-soltamox-tamoxifen-342183


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