Teslac (Testolactone) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

The recommended oral dose is 250 mg qid.

In order to evaluate the response, therapy with testolactone should be continued for a minimum of three months unless there is active progression of the disease.

HOW SUPPLIED

TESLAC^® (testolactone tablets, USP), 50 mg/tablet: bottles of 100 (NDC 0003-0690-50). Each round, white, biconvex tablet is imprinted with the identification number 690.

Storage

Store at controlled room temperature 25° C (77° F).

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
Made in Australia

J4666B
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