Drugs List

Therapeutic Indications

Uses

Hormone-dependent metastatic breast cancer in postmenopausal patients

Contraindications

Suspected endometrial cancer
Breastfeeding
Congestive cardiac failure with reduced left ventricular ejection fraction
Electrolyte imbalance
Endometrial hyperplasia
Galactosaemia
History of cardiac arrhythmias
Pregnancy
QTc interval greater than or equal to 500 msec
Severe bradycardia
Severe hepatic impairment
Severe thromboembolic disorder
Torsade de pointes

Precautions and Warnings

Elderly
Family history of long QT syndrome
Risk factors for endometrial cancer
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
Severe angina
Skeletal metastasis
Uncontrolled cardiac failure

Correct electrolyte disorders before treatment
Exclude endometrial abnormalities before treatment
Treatment to be initiated and supervised by a specialist
Contains lactose
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

Pregnancy

Toremifene is contraindicated in pregnancy.

Toremifene is indicated for postmenopausal patients.

Animal studies have shown reproductive toxicity.

Lactation

Toremifene is contraindicated in breastfeeding.

In rats decreased body weight gain of the offspring during lactation was observed.

Side Effects

Alopecia
Anaemia
Anorexia
Constipation
Corneal opacity (reversible)
Decreased appetite
Deep vein thrombosis (DVT)
Depression
Dizziness
Dyspnoea
Endometrial hyperplasia
Endometrial hypertrophy
Endometrial neoplasia
Endometrial polyps
Fatigue
Headache
Hepatitis
Hepatocellular damage
Hot flushes
Hypercalcaemia
Increase of liver transaminases
Insomnia
Jaundice
Leucorrhoea
Leukopenia
Nausea
Oedema
Prolongation of QT interval
Pruritus
Pulmonary embolism
Rash
Sweating
Thrombocytopenia
Thromboembolic disorders
Thrombophlebitis
Uterine bleeding
Vertigo
Vomiting
Weight gain

Presentation

Oral formulations containing toremifene

Drugs List

Therapeutic Indications

Uses

Hormone-dependent metastatic breast cancer in postmenopausal patients

Dosage

Adults

Contraindications

Suspected endometrial cancer
Breastfeeding
Congestive cardiac failure with reduced left ventricular ejection fraction
Electrolyte imbalance
Endometrial hyperplasia
Galactosaemia
History of cardiac arrhythmias
Pregnancy
QTc interval greater than or equal to 500 msec
Severe bradycardia
Severe hepatic impairment
Severe thromboembolic disorder
Torsade de pointes

Precautions and Warnings

Elderly
Family history of long QT syndrome
Risk factors for endometrial cancer
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
Severe angina
Skeletal metastasis
Uncontrolled cardiac failure

Correct electrolyte disorders before treatment
Exclude endometrial abnormalities before treatment
Treatment to be initiated and supervised by a specialist
Contains lactose
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

Pregnancy

Toremifene is contraindicated in pregnancy.

Toremifene is indicated for postmenopausal patients.

Animal studies have shown reproductive toxicity.

Lactation

Toremifene is contraindicated in breastfeeding.

In rats decreased body weight gain of the offspring during lactation was observed.

Side Effects

Alopecia
Anaemia
Anorexia
Constipation
Corneal opacity (reversible)
Decreased appetite
Deep vein thrombosis (DVT)
Depression
Dizziness
Dyspnoea
Endometrial hyperplasia
Endometrial hypertrophy
Endometrial neoplasia
Endometrial polyps
Fatigue
Headache
Hepatitis
Hepatocellular damage
Hot flushes
Hypercalcaemia
Increase of liver transaminases
Insomnia
Jaundice
Leucorrhoea
Leukopenia
Nausea
Oedema
Prolongation of QT interval
Pruritus
Pulmonary embolism
Rash
Sweating
Thrombocytopenia
Thromboembolic disorders
Thrombophlebitis
Uterine bleeding
Vertigo
Vomiting
Weight gain

Overdosage

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 ).

Further Information

Last Full Review Date: February 2021

Reference Sources

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.