Fareston (toremifene) dosing, indications, interactions, adverse effects, and more

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Sections toremifene
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
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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

Interaction Checker

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Interactions Found

Contraindicated

Serious - Use Alternative

Significant - Monitor Closely

Minor

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>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

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

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.

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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Patient Handout

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections toremifene
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

toremifene (Rx)