Uses
FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Source: US FDA prescribing information
- Presentations
- 2
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Toremifene is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. It is available as tablets for oral use. MedsAcross supplies Toremifene for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Estrogen Agonist/Antagonist, Selective Estrogen Receptor Modulators
- ATC classification
- L02BA02 Toremifene · Estrogen antagonist
- US FDA first approval
- 29 May 1997
- EU status
- Authorised
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet
- Identifiers
- UNII 7NFE54O27TRxCUI 38409CAS 89778-26-7DrugBank DB00539Q3993743
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Toremifene is a nonsteroidal triphenylethylene derivative. Toremifene binds to estrogen receptors and may exert estrogenic, antiestrogenic, or both activities, depending upon the duration of treatment, animal species, gender, target organ, or endpoint selected. In general, however, nonsteroidal triphenylethylene derivatives are predominantly antiestrogenic in rats and humans and estrogenic in mice. In rats, toremifene causes regression of established dimethylbenzanthracene (DMBA)-induced mammary tumors. The antitumor effect of toremifene in breast cancer is believed to be mainly due to its antiestrogenic effects, i.e., its ability to compete with estrogen for binding sites in the cancer, blocking the growth-stimulating effects of estrogen in the tumor.
Source: US FDA prescribing information
Dosing overview
The dosage of FARESTON is 60 mg, once daily, orally. Treatment is generally continued until disease progression is observed. 60 mg once daily, orally
Source: US FDA prescribing information
Contraindications
Hypersensitivity to the drug. QT Prolongation, Hypokalemia, Hypomagnesemia Hypersensitivity to the Drug FARESTON is contraindicated in patients with known hypersensitivity to the drug.
Source: US FDA prescribing information
Warnings and precautions
Boxed 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. Prolongation of the QT Interval. Heptatotoxicty. Hypercalcemia and Tumor Flare. Risk of Uterine Malignancy. General. Laboratory Tests. Pregnancy: Fetal harm may occur when administered to a pregnant woman. Women should be advised not to become pregnant when taking FARESTON. Women of Childbearing Potential: Use effective nonhormonal contraception during FARESTON therapy.
Source: US FDA prescribing information
Side effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Most common adverse reactions are hot flashes, sweating, nausea and vaginal discharge.
Source: US FDA prescribing information
Interactions
Drugs that decrease renal calcium excretion, e.g., thiazide diuretics, may increase the risk of hypercalcemia in patients receiving FARESTON. Agents that prolong QT should be avoided. Coadministration with a strong CYP3A4 inducer may result in a relevant decrease in FARESTON exposure and should be avoided. Coadministration with a strong CYP3A4 inhibitor can result in a relevant increase in FARESTON exposure and should be avoided. CYP2C9 substrates with a narrow therapeutic index such as warfarin or phenytoin with FARESTON should be used with caution and require careful monitoring.
Source: US FDA prescribing information
Storage
Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F) Protect from heat and light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
2 presentations of Toremifene, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Toremifene 60 mg tabletOralGeneric name | — | US FDA | Available on request |
| Fareston 60 mg tabletOral | Kyowa Kirin | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions
Conditions linked to Toremifene in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Toremifene available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Toremifene and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Toremifene have?
The catalogue lists 1 brand names for Toremifene, including Fareston.
Is Toremifene approved by the US FDA?
Yes. The US FDA first approved Toremifene on 29 May 1997, according to Drugs@FDA.
Is Toremifene authorised in the European Union?
Yes. Toremifene has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Toremifene need cold chain shipping?
No listed presentation of Toremifene is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Toremifene in?
Toremifene is classified under ATC code L02BA02 (Toremifene).
References
- Fareston prescribing information (Kyowa Kirin). U.S. National Library of Medicine, DailyMed. Retrieved 13 November 2024
- Fareston: European public assessment report (EPAR). European Medicines Agency. Retrieved 30 July 2024
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