Toremifene

Toremifene
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Black Box Warning

WARNING: QT PROLONGATION : See full prescribing information for complete Boxed Warning. WARNING: QT PROLONGATION : FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene 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 CYP3A4 inhibitors should be avoided

Overview

Toremifene is a antineoplasic agent that is FDA approved for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hot flashes, sweating, nausea and vaginal discharge.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.

Dosage

• The dosage of FARESTON is 60 mg, once daily, orally. Treatment is generally continued until disease progression is observed.

DOSAGE FORMS AND STRENGTHS

• Tablet is 60 mg, round, convex, unscored, uncoated, and white, or almost white, identified with TO 60 embossed on one side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Toremifene in adult patients.

Non–Guideline-Supported Use

• Fracture of vertebral column; Prophylaxis - Prostate cancer, Receiving androgen deprivation therapy

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Toremifene in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Toremifene in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Toremifene in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING: QT PROLONGATION : See full prescribing information for complete Boxed Warning. WARNING: QT PROLONGATION : FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene 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 CYP3A4 inhibitors should be avoided

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Toremifene in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Toremifene in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Toremifene in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Toremifene during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Toremifene with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Toremifene with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Toremifene with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Toremifene with respect to specific gender populations.

Race

There is no FDA guidance on the use of Toremifene with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Toremifene in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Toremifene in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Toremifene in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Toremifene in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Toremifene in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Toremifene in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Toremifene in the drug label.

Pharmacology

There is limited information regarding Toremifene Pharmacology in the drug label.

Mechanism of Action

Structure

File:Toremifene01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Toremifene in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Toremifene in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Toremifene in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Toremifene in the drug label.

How Supplied

Storage

There is limited information regarding Toremifene Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Toremifene in the drug label.

Precautions with Alcohol

• Alcohol-Toremifene interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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