Fareston

TOREMIFENE CITRATE

Manufacturer: Kyowa Kirin, Inc.

Score: 147.83

Quick Summary

Toremifene citrate is an estrogen agonist/antagonist used for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. The recommended dosage is 60 mg once daily, orally. Toremifene citrate has been shown to prolong the QTc interval and should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia, or uncorrected hypomagnesemia. The most common adverse reactions are hot flashes, sweating, nausea, and vaginal discharge.

Key Clinical Findings and Indications

Treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors
Estrogen agonist/antagonist
Prolongation of the QTc interval

Important Safety Information

Warning

Toremifene citrate has been shown to prolong the QTc interval and should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia, or uncorrected hypomagnesemia

Contraindications

Hypersensitivity to the drug
Congenital/acquired QT prolongation
Uncorrected hypokalemia
Uncorrected hypomagnesemia

Adverse Reactions

Hot flashes
Sweating
Nausea
Vaginal discharge
Vaginal bleeding
Thrombophlebitis
Thrombosis
Pulmonary embolism

Dosing Recommendations

General Guidance

No dose adjustments are recommended

Metastatic breast cancer

Adult Dose

60 mg once daily, orally

Pediatric Dose

Special Population Considerations

Pregnancy

Toremifene citrate can cause fetal harm when administered to a pregnant woman
Pregnancy Category D

Nursing Mothers

It is not known if toremifene is excreted in human milk
A decision should be made to either discontinue nursing or discontinue the drug

Pediatric Use

There is no indication for use of toremifene citrate in pediatric patients

Geriatric Use

The pharmacokinetics of toremifene were studied in 10 healthy young males and 10 elderly females
No significant age-related differences in toremifene citrate effectiveness or safety were noted