Tamoxifen (Nolvadex)

General information

Class/mechanism: SERM (selective estrogen receptor modulator), with estrogen agonist/antagonist properties depending on tissue type. Tamoxifen has estrogen antagonist properties in breast tissue. It has estrogen agonist properties in bone, helping to decrease bone resorption, but in contrast to Raloxifene (Evista), it also has agonist properties in uterine tissue.^[1]^[2]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

1977-12-30: Initial FDA approval
Uncertain date: Approved for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. (Based on ECOG 1178, Hubay et al. 1980, NATO, NCIC-CTG MA.4, NSABP B-09, NSABP B-14)
Uncertain date: Approved for the treatment of metastatic breast cancer in women and men. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from NOLVADEX therapy. (Based on Crump et al. 1997)
1989-03-16: Approved for use in premenopausal women with metastatic breast cancer as an alternative to oophorectomy or ovarian radiation. (Based on Buchanan et al. 1986, Crump et al. 1997, Ingle et al. 1986a)
1998-10-29: Approved to reduce the occurrence of contralateral breast cancer in patients receiving adjuvant Nolvadex therapy for breast cancer.
1998-10-29: Approved to reduce the incidence of breast cancer in women at high risk for breast cancer.

History of changes in EMA indication

1974-04-29: EURD

Also known as

Code name: ICI-46474
Generic names: TAM, tamoxifen citrate, TMX
Brand names: Istubal, Nolvadex, Soltamox, Valodex

References

[insert-1] 1.0 ^1.1 ^1.2 Tamoxifen (Nolvadex) package insert

[2] Tamoxifen (Nolvadex) package insert (locally hosted backup)

[3] Tamoxifen (Nolvadex) patient drug information (Chemocare)

[4] Tamoxifen (Nolvadex) patient drug information (UpToDate)

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