Teslac

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. Revised May 2004

Certain signs and symptoms have been reported in association with the use of this drug but, in these instances, it is often impossible to determine the relationship of the underlying disease and drug administration to the reported reaction. Such reactions include maculopapular erythema, increase in blood pressure, paresthesia, malaise, aches and edema of the extremities, glossitis, anorexia, and nausea and vomiting. Alopecia alone and with associated nail growth disturbance have been reported rarely; these side effects subsided without interruption of treatment.

Drug Abuse And Dependence

TESLAC (testolactone) is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III.

There have been no reports of acute overdosage with testolactone tablets.

In the U.S.

• Teslac

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Androgen

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. Testolactone is chemically designated as 13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid δ-lactone. Graphic formula:

Inactive ingredients: calcium stearate, cornstarch, gelatin, and lactose.

Testolactone is a white, odorless, crystalline solid, soluble in ethanol and slightly soluble in water.

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.

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.

Applies to testolactone: oral tablet

Along with its needed effects, testolactone (the active ingredient contained in Teslac) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking testolactone:

• Numbness or tingling of fingers, toes, or face

Some side effects of testolactone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• loss of appetite
• nausea or vomiting
• pain or swelling in feet or lower legs
• swelling or redness of tongue

Applies to testolactone: oral tablet

Gastrointestinal

Gastrointestinal effects including glossitis, anorexia, nausea, and vomiting have been reported.[Ref]

Cardiovascular

Cardiovascular effects including increase in blood pressure and edema of the extremities have been reported.[Ref]

Nervous system

Nervous system effects including paresthesia have been reported.[Ref]

Dermatologic

Dermatologic effects including maculopapular erythema have been reported. Alopecia, both with or without associated nail growth disturbance has been reported rarely.[Ref]

General

General effects including malaise and aches in the extremities have been reported.[Ref]

Some side effects of Teslac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

There are no data on the excretion of testolactone into human milk. Testolactone is intended for use only in postmenopausal women. If the physician does wish to use this medication in a lactating women, it should be taken into account that because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to testolactone in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.