TESLAC SUMMARY
TESLAC®
(testolactone tablets, USP)
TESLAC® (testolactone tablets, USP) is available for oral administration as tablets providing 50 mg testolactone per tablet. Testolactone is a synthetic antineoplastic agent that is structurally distinct from the androgen steroid nucleus in possessing a six-membered lactone ring in place of the usual five-membered carbocyclic D-ring.
TESLAC (testolactone tablets, USP) is recommended as adjunctive therapy in the palliative treatment of advanced or disseminated breast cancer in postmenopausal women when hormonal therapy is indicated. It may also be used in women who were diagnosed as having had disseminated breast carcinoma when premenopausal, in whom ovarian function has been subsequently terminated.
TESLAC (testolactone tablets, USP) was found to be effective in approximately 15 percent of patients with advanced or disseminated mammary cancer evaluated according to the following criteria: 1) those with a measurable decrease in size of all demonstrable tumor masses; 2) those in whom more than 50 percent of non-osseous lesions decreased in size although all bone lesions remained static; and 3) those in whom more than 50 percent of total lesions improved while the remainder were static.
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