toremifene (Rx)

Brand and Other Names:Fareston
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 60mg

Breast Cancer

60 mg PO qDay until disease progresses

Monitor patients on warfarin for increased PT

Desmoid Tumors (Orphan)

Indicated for treatment of desmoid tumors

Orphan indication sponsor

  • Orion Corporation; PO Box 65; 02101 Espoo; FINLAND

Other Indications & Uses

Estrogen-receptor positive or unknown metastatic breast cancer in postmenopausal women

Not recommended

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Interactions

Interaction Checker

and toremifene

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hot flashes (35%)

            Sweating (20%)

            Nausea (14%)

            Vaginal discharge (13%)

            1-10%

            Cataracts (10%)

            Dizziness (9%)

            Edema (5%)

            Vomiting (4%)

            Dry eyes (4%)

            Hypercalcemia (3%)

            Thrombophlebitis (2%)

            Vaginal bleeding (2%)

            <1%

            Alopecia

            Angina

            Hepatitis

            Dermatitis

            Depression

            Corneal opacity

            Postmarketing

            Hepatototoxicity

            Risk of uterine malignancy

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            Warnings

            Black Box Warnings

            Prolongs QTc interval in a dose- and concentration-related manner

            QT prolongation can result in Torsade de pointes, which may result in syncope, seizure, and/or death

            Should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia

            Drugs known to prolong QT interval and strong CYP3A4 inhibitors should be avoided

            Contraindications

            Hypersensitivity

            Estrogen receptor-negative tumors

            Thromboembolic history

            Should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia

            Cautions

            May increase risk of ovarian CA, osteosarcoma

            Risk of hypercalcemia & tumor flare

            Long-term treatment discouraged in preexisting endometrial hyperplasia

            Prolongs QTc interval; avoid in patients with congenital/acquired QT prolongation or uncorrected hypokalemia/hypomagnesemia

            Avoid concomitant use of drugs known to prolong QT interval

            Hepatotoxicity, both increases in serum concentration for grade 3 and 4 transaminitis; hyperbilirubinemia, including jaundice, hepatitis, and non-alcoholic fatty liver disease, have also been reported in clinical trials and postmarketing; liver function tests should be performed periodically

            Endometrial cancer, endometrial hypertrophy, hyperplasia, and uterine polyps reported; endometrial hyperplasia of uterus observed in animals treated with toremifene; long-term use has not been established in patients with pre-existing endometrial hyperplasia; all patients should have baseline and annual gynecological examinations; patients at high risk of endometrial cancer should be closely monitored

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Not known if excreted in breast milk, indicated in postmenopausal women

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Selective estrogen receptor modulator: nonsteroidal estrogen, agonist/antagonist, competes for estrogen binding sites on breast tumor cells

            Pharmacokinetics

            Half-Life: 5 days

            Peak Plasma Time: 3 hr

            Protein Bound: >99.5%

            Vd: 580 L

            Metabolism: Hepatic CYP3A4

            Metabolites: N-demethyltoremifene, (deamino-hydroxy) toremifene

            Clearance: 5 L/hr

            Excretion: Feces (primarily); urine (10%)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.