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Pronunciation:

(tes toe LAK tone)

U.S. Brand Names:

Teslac®

Generic Available:

Canadian Brand Names:

Teslac®

Use:

Palliative treatment of advanced or disseminated breast carcinoma

Restrictions:

C-III

Pregnancy Risk Factor:

Pregnancy Implications:

Teratogenic effects were not observed in animal studies. Testolactone should only be used in postmenopausal women; use during pregnancy is not recommended.

Lactation:

Excretion in breast milk unknown/not recommended

Contraindications:

Hypersensitivity to testolactone or any component of the formulation; treatment of breast cancer in men

Warnings/Precautions:

Use with caution in hepatic, renal, or cardiac disease; prolonged use may cause drug-induced hepatic disease; history of porphyria. For use in postmenopausal women or in premenopausal women without ovarian function only. Safety and efficacy in pediatric patients have not been established.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Edema, blood pressure increased

Central nervous system: Malaise

Dermatologic: Maculopapular rash, alopecia (rare)

Endocrine & metabolic: Hypercalcemia

Gastrointestinal: Anorexia, diarrhea, nausea, edema of the tongue

Neuromuscular & skeletal: Paresthesias, peripheral neuropathies

Miscellaneous: Nail growth disturbance (rare)

Drug Interactions:

Increased toxicity: Increased effects of oral anticoagulants

Mechanism of Action:

Testolactone is a synthetic testosterone derivative without significant androgen activity. The drug inhibits steroid aromatase activity, thereby blocking the production of estradiol and estrone from androgen precursors such as testosterone and androstenedione. Unfortunately, the enzymatic block provided by testolactone is transient and is usually limited to a period of 3 months.

Pharmacodynamics/Kinetics:

Absorption: Well absorbed

Metabolism: Hepatic (forms metabolites)

Excretion: Urine

Dosage:

Adults: Female: Oral: 250 mg 4 times/day for at least 3 months; desired response may take as long as 3 months

Monitoring Parameters:

Plasma calcium levels

Test Interactions:

Plasma estradiol concentrations by RIA

Patient Education:

Take as directed; do not discontinue without consulting prescriber. Effectiveness of therapy may take several months. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake, and diet and exercise program recommended by prescriber. You may experience nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help). Report fluid retention (swelling of ankles, feet, or hands; respiratory difficulty or sudden weight gain); numbness, tingling, or swelling of fingers, toes, or face; skin rash, redness, or irritation; or other adverse reactions. Pregnancy precaution: Breast-feeding is not recommended.

Nursing Implications:

Monitor plasma calcium levels

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Oncology: Emetic Potential:

Very low (<10%)

Dosage Forms:

Tablet: 50 mg

International Brand Names:

Teslac® (CA, CL)

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