Drug Guide
Testolactone
Classification
Therapeutic: Hormone inhibitor, Antineoplastic agent
Pharmacological: Lactamase inhibitor, Aromatase inhibitor
FDA Approved Indications
- Metastatic breast cancer in postmenopausal women
Mechanism of Action
Testolactone inhibits aromatase enzyme activity, resulting in decreased estrogen synthesis, which helps to slow the growth of estrogen-dependent breast cancer cells.
Dosage and Administration
Adult: Typically 200 mg orally twice daily, as per specific protocol and physician's guidance.
Pediatric: Not generally used in pediatric patients.
Geriatric: No specific dose adjustments solely based on age, but renal and hepatic functions should be considered.
Renal Impairment: Use with caution; no specific dosage adjustment recommended without further renal function assessment.
Hepatic Impairment: Use caution; hepatic function should be evaluated before and during therapy, dose adjustments may be necessary.
Pharmacokinetics
Absorption: Rapid oral absorption.
Distribution: Widely distributed in body tissues, crosses the placenta.
Metabolism: Metabolized in the liver.
Excretion: Excreted mainly in urine; small amount in feces.
Half Life: Approximately 2-3 hours.
Contraindications
- Hypersensitivity to testolactone or other components.
- Pregnancy and lactation, due to risk of fetal harm.
Precautions
- Monitor hepatic and renal function during therapy.
- Use cautiously in patients with a history of liver disease.
Adverse Reactions - Common
- Hot flashes (Common)
- Nausea (Common)
- Fatigue (Common)
- Gynecomastia (Common)
Adverse Reactions - Serious
- Hepatic dysfunction/liver enzyme elevation (Serious (rare), monitor liver function.)
- Allergic reactions (Serious (rare))
- Blood dyscrasias (Rare)
Drug-Drug Interactions
- CYP3A4 inducers or inhibitors may alter testolactone levels.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor liver function tests, hepatic enzymes, and symptoms of hepatotoxicity.
Diagnoses:
- Risk for hepatotoxicity
- Risk for hormonal imbalance
Implementation: Administer as prescribed, monitor for adverse effects, educate patient.
Evaluation: Assess for reduction in tumor size, monitor liver function tests, and evaluate adverse reactions.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report symptoms of hepatic dysfunction (jaundice, abdominal pain).
- Inform about potential hot flashes and other hormonal effects.
Special Considerations
Black Box Warnings:
- None specific for testolactone.
Genetic Factors: No specific genetic considerations.
Lab Test Interference: May affect hormone levels; inform lab personnel of ongoing treatment.
Overdose Management
Signs/Symptoms: Nausea, vomiting, hypotension, or other adverse effects.
Treatment: Supportive care; activated charcoal if recent ingestion; no specific antidote.
Storage and Handling
Storage: Store at room temperature, away from moisture and heat.
Stability: Stable under normal conditions for the duration of the labeled shelf life.