TOREMIFENE CITRATE
Details
- Status
- Prescription
- First Approved
- 2018-12-04
- Routes
- ORAL
- Dosage Forms
- TABLET
TOREMIFENE CITRATE Approval History
What TOREMIFENE CITRATE Treats
1 indicationsTOREMIFENE CITRATE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
TOREMIFENE CITRATE Boxed Warning
QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. 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 ...
WARNING: QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. 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 [see Warnings and Precautions ( 5.1 )]. WARNING: QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. 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 [see Warnings and Precautions ( 5.1) ].
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TOREMIFENE CITRATE FDA Label Details
ProIndications & Usage
Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
WARNING: QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may resul...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.