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Nolvadex

Tamoxifen is an oral selective estrogen receptor modulator which is used in breast cancer treatment, and is currently the world's largest selling breast cancer treatment. It is used for the treatment of early and advanced breast cancer in pre- and post-menopausal women. It is also approved by the FDA for the reduction of the incidence of breast cancer in women at high risk of developing the disease. It has been further approved for the reduction of contralateral (in the opposite breast) breast cancer. more...

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Tamoxifen was invented by ICI Pharmaceuticals (now AstraZeneca) and is sold under the brand names Nolvadex, Istubal, and Valodex. It is also available as a generic drug in a number of countries. In the United States, the drug was almost always referred by its generic name, even before patent expiration.

A rare condition occasionally treated with tamoxifen is retroperitoneal fibrosis.

Tamoxifen is sometimes used to treat gynecomastia in men. Tamoxifen is also used by bodybuilders to try and prevent or reduce drug-induced gynecomastia caused by steroids.

4-hydroxytamoxifen

4-hydroxytamoxifen is a form of the drug tamoxifen that is made by the body after taking tamoxifen. It can also be made in the laboratory, and may help decrease breast density. A topical form of 4-hydroxytamoxifen is being studied in breast cancer screening.

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Nolvadex
From OB/GYN News, 8/15/00 by Elizabeth Mechcatie

(tamoxifen citrate, AstraZeneca Pharmaceuticals)

A nonsteroidal anti-estrogenic agent for women with ductal carcinoma in situ (DCIS) following breast surgery and radiation therapy Nolvadex is indicated to reduce the risk of invasive breast cancer.

* Dosage: 20 mg a day for 5 years.

* Special Considerations: In the study that led to the approval, the side effects of Nolvadex in women with DCIS were similar to those in other trials of Nolvadex and included hot flashes and vaginal discharge. In the DCIS trial, the rate of endometrial cancer was increased in the Nolvadex-treated patients, but no cases were fatal.

* Comments: Approval for the indication was based on results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study of 1,804 women with DCIS, who had a lumpectomy and radiation therapy, and received either tamoxifen (20 mg a day) or a placebo. After a median follow-up of 6 years, 44 of the women in the tamoxifen group developed invasive breast cancer, compared with 74 women on the placebo, a 43% reduction in risk of invasive breast cancer. Five years after entry into the study, 97% of women in each group were still alive (Lancet, 353[9169]:1993-2000, 1999).

"The value of tamoxifen used in combination with radiation therapy to lower the occurrence of invasive cancer justifies" its replacement of mastectomy for DCIS patients who are unlikely to have invasive tumors, the NSABP team concluded.

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