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

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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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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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Fareston oral
            -
            60 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            toremifene oral

            TOREMIFENE - ORAL

            (tor-EM-eh-feen)

            COMMON BRAND NAME(S): Fareston

            WARNING: Toremifene has caused very serious (possibly fatal) heart rhythm problems (QT prolongation in the EKG, torsades de pointes). Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, seizures, severe dizziness, or fainting. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using toremifene, tell your doctor or pharmacist of all the drugs you take (see also Drug Interaction section) and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using toremifene safely.

            USES: Toremifene is used in postmenopausal women to treat breast cancer. It is usually used to treat cancer that needs estrogen, a female hormone, in order to grow (estrogen-receptor positive). Toremifene is a nonsteroidal antiestrogen that blocks the effects of estrogen in the breast tissue, thereby slowing or stopping the growth of cancer.

            HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.Tell your doctor right away if your condition worsens (such as you get new breast lumps).

            SIDE EFFECTS: See also Warning section.Hot flashes, sweating, nausea, vomiting, dry eyes, or dizziness may occur. If any of these side effects last or get worse, tell your doctor promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: bone/joint/muscle pain or swelling, constipation, mental/mood changes (such as depression), trouble walking/clumsiness, swelling ankles/feet, unusual tiredness, vision changes (such as blurred vision, eye pain), easy bleeding/bruising, signs of infection (such as sore throat that doesn't go away, fever, chills), symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).Toremifene may increase your risk of uterine cancer. Tell your doctor right away if you develop changes in menstrual period, unusual vaginal bleeding/discharge or pain/pressure below your "belly button" (navel).Toremifene has rarely caused very serious (possibly fatal) blood clots in the lungs/legs, brain (stroke), and heart (heart attack). Get medical help right away if you develop pain/swelling in the groin/calf, pain in the chest/jaw/left arm, confusion, fainting, severe sudden headache, trouble speaking, sudden vision changes, shortness of breath, or weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: See also Warning section.Before taking toremifene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone cancer (metastases), blood disorders (such as anemia, low platelets), diabetes, history of stroke or other blood clots (such as in the legs, lungs), heart disease (such as heart attack, irregular heartbeat), high blood pressure, liver disease, long periods of sitting or lying down (for example, due to immobility such as being bedridden), uterus problems such as endometrial hyperplasia.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as on a long plane flight).During pregnancy, toremifene should be used only when clearly needed. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor right away. Women of childbearing age should use reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. Discuss the use of birth control, the risks and benefits of this medication, and any other concerns about using this medication with your doctor.It is not known if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin), estrogens, tibolone, drugs affecting liver enzymes that remove toremifene from your body (including certain anti-seizure medications such as carbamazepine/clonazepam/phenobarbital/phenytoin, rifampin).Many drugs besides toremifene may affect the heart rhythm (QT prolongation), including amiodarone, granisetron, pimozide, procainamide, quinidine, sotalol, and macrolide antibiotics (such as erythromycin), among others.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, calcium levels, liver tests, pelvic exam) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised September 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            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.
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            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.