60 mg orally once daily
Duration of therapy: Treatment is generally continued until disease progression is observed.
Use: Treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Renal Dose Adjustments
No adjustment listed in the manufacturer product information; however, dosage adjustment is unlikely to be necessary.
Liver Dose Adjustments
No adjustment listed in the manufacturer product information; however, hepatic impairment increases the half-life of this drug. Caution is recommended.
Precautions
US BOXED WARNING:
This drug has been shown to prolong the QTc interval in a dose- and concentration-related manner.
QT prolongation can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death.
This drug should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia, or uncorrected hypomagnesemia.
Drugs known to prolong the QT interval and strong CYP450 3A4 inhibitors should be avoided.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available.
Other Comments
Administration Advice:
This drug can be taken with or without food.
General:
Overdose: There is no specific antidote and treatment is symptomatic.
Treatment with this drug is associated with modest reductions in both total serum cholesterol and low density lipoprotein in postmenopausal breast cancer patients.
This drug displayed non-estrogen-dependent anti-tumor effects when used in some experimental cancers and/or in high-dose.
Monitoring:
Electrolytes, ECG (prior to and during treatment)
Red blood cell, leukocyte, and platelet counts (during treatment)
Complete blood counts, calcium levels, liver function tests (during treatment)
Gynecological exam (prior to treatment and at least once a year during treatment)
Patient Advice:
Talk to your healthcare provider about foods (ex: grapefruit) and medications (ex: certain antibiotics) that should be avoided during treatment with this drug.
