- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations containing toremifene
Hormone-dependent metastatic breast cancer in postmenopausal patients
60 mg once daily.
Suspected endometrial cancer
Congestive cardiac failure with reduced left ventricular ejection fraction
History of cardiac arrhythmias
QTc interval greater than or equal to 500 msec
Severe hepatic impairment
Severe thromboembolic disorder
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Risk factors for endometrial cancer
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Ischaemic heart disease
Mild hepatic impairment
Uncontrolled cardiac failure
Correct electrolyte disorders before treatment
Exclude endometrial abnormalities before treatment
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Perform a complete physical and gynaecological examination before therapy
Follow up at least annually with physical and gynaecological examination
Investigate if abnormal vaginal bleeding, pain or discharge occurs
Monitor blood counts regularly
Monitor calcium in patients with skeletal metastases
Monitor ECG in patients at risk of QT prolongation
Monitor patients with cardiac disorders
Monitor serum electrolytes
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Discontinue at first sign of arrhythmia - perform ECG
Advise patients risk of endometrial cancer and to report relevant symptoms
Elderly patients may be more susceptible to drug associated effects on the QT interval.
Patients with additional risk factors for endometrial cancer such as hypertension, diabetes, high BMI (greater than 30 kg/square metre) or a history of hormone replacement therapy, should be closely monitored.
Use with caution in patients with ongoing pro arrhythmic conditions due to an increased risk of ventricular arrhythmias and cardiac arrest.
Cases of hepatic injury including elevations of liver enzymes, jaundice and hepatitis have been reported in patients receiving toremifene. Most occurred within the first months of treatment and were predominantly hepatocellular.
Toremifene is not recommended for patients oestrogen receptor negative tumour.
Pregnancy and Lactation
Toremifene is contraindicated in pregnancy.
Toremifene is indicated for postmenopausal patients.
Animal studies have shown reproductive toxicity.
Toremifene is contraindicated in breastfeeding.
In rats decreased body weight gain of the offspring during lactation was observed.
Corneal opacity (reversible)
Deep vein thrombosis (DVT)
Increase of liver transaminases
Prolongation of QT interval
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: February 2021
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 12 October 2015.
Summary of Product Characteristics: Fareston 60mg tablets. Orion pharma. Revised June 2017.
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org/monograph2.php?id=3085
Last accessed: 12 February, 2021.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.