Drugs List

Therapeutic Indications

Uses

Prophylaxis of postmenopausal osteoporosis
Treatment of postmenopausal osteoporosis

Unlicensed Uses

Prevention of breast cancer (postmenopausal women at moderate to high risk)

Contraindications

Suspected endometrial cancer
Breastfeeding
Cholestasis
Deep vein thrombosis
Hepatic impairment
History of thromboembolic disorder
Pregnancy
Pulmonary embolism
Retinal blood vessel occlusion
Severe renal impairment
Thromboembolic disorder
Undiagnosed gynaecological haemorrhage

Precautions and Warnings

Predisposition to venous thromboembolism
Atrial fibrillation
Breast cancer
Galactosaemia
Glucose-galactose malabsorption syndrome
History of cerebrovascular accident
History of oestrogen induced hypertriglyceridaemia
Lactose intolerance
Mild renal impairment
Porphyria
Transient ischaemic attack

Not for menopausal symptoms associated with oestrogen deficiency
Some brands contain lactose
Exclude pregnancy prior to initiation of treatment
Breakthrough bleeding should be investigated
Ensure patient's dietary intake of calcium and vitamin D is adequate
Monitor anticoagulant drug treatment
Monitor levels of hepatic enzymes and bilirubin
Monitor serum triglyceride concentration
Advise patient to seek advice at first indications of pregnancy
Discontinue in the event of a prolonged period of immobilisation
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Raloxifene hydrochloride is contraindicated in pregnancy.

Raloxifene is only for use in post menopausal women.

Raloxifene must not be taken by women of childbearing potential. Raloxifene may cause foetal harm when administered to a pregnant woman. If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Raloxifene hydrochloride is contraindicated in breastfeeding.

It is not known whether raloxifene is excreted in human milk. Its clinical use, therefore, cannot be recommended in breastfeeding women. Raloxifene may affect the development of the infant.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Arterial thrombosis
Benign endometrial polyps
Breast enlargement
Breast pain
Breast tenderness
Cerebrovascular accident
Cholelithiasis
Deep vein thrombosis (DVT)
Dyspepsia
Endometrial atrophy
Headache
Hot flushes
Hypertension
Increase in serum ALT/AST
Increased blood pressure
Influenza-like syndrome
Leg cramps
Migraine
Nausea
Peripheral oedema
Pulmonary embolism
Rash
Reduced platelet count
Retinal vein thrombosis
Superficial vein thrombophlebitis
Thrombocytopenia
Uterine bleeding - requires investigation.
Venous thrombosis
Vomiting

Presentation

Oral formulations containing raloxifene hydrochloride

Drugs List

Therapeutic Indications

Uses

Prophylaxis of postmenopausal osteoporosis
Treatment of postmenopausal osteoporosis

Unlicensed Uses

Prevention of breast cancer (postmenopausal women at moderate to high risk)

Dosage

Adults

Patients with Renal Impairment

Contraindications

Suspected endometrial cancer
Breastfeeding
Cholestasis
Deep vein thrombosis
Hepatic impairment
History of thromboembolic disorder
Pregnancy
Pulmonary embolism
Retinal blood vessel occlusion
Severe renal impairment
Thromboembolic disorder
Undiagnosed gynaecological haemorrhage

Precautions and Warnings

Predisposition to venous thromboembolism
Atrial fibrillation
Breast cancer
Galactosaemia
Glucose-galactose malabsorption syndrome
History of cerebrovascular accident
History of oestrogen induced hypertriglyceridaemia
Lactose intolerance
Mild renal impairment
Porphyria
Transient ischaemic attack

Not for menopausal symptoms associated with oestrogen deficiency
Some brands contain lactose
Exclude pregnancy prior to initiation of treatment
Breakthrough bleeding should be investigated
Ensure patient's dietary intake of calcium and vitamin D is adequate
Monitor anticoagulant drug treatment
Monitor levels of hepatic enzymes and bilirubin
Monitor serum triglyceride concentration
Advise patient to seek advice at first indications of pregnancy
Discontinue in the event of a prolonged period of immobilisation
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Raloxifene hydrochloride is contraindicated in pregnancy.

Raloxifene is only for use in post menopausal women.

Raloxifene must not be taken by women of childbearing potential. Raloxifene may cause foetal harm when administered to a pregnant woman. If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Raloxifene hydrochloride is contraindicated in breastfeeding.

It is not known whether raloxifene is excreted in human milk. Its clinical use, therefore, cannot be recommended in breastfeeding women. Raloxifene may affect the development of the infant.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Arterial thrombosis
Benign endometrial polyps
Breast enlargement
Breast pain
Breast tenderness
Cerebrovascular accident
Cholelithiasis
Deep vein thrombosis (DVT)
Dyspepsia
Endometrial atrophy
Headache
Hot flushes
Hypertension
Increase in serum ALT/AST
Increased blood pressure
Influenza-like syndrome
Leg cramps
Migraine
Nausea
Peripheral oedema
Pulmonary embolism
Rash
Reduced platelet count
Retinal vein thrombosis
Superficial vein thrombophlebitis
Thrombocytopenia
Uterine bleeding - requires investigation.
Venous thrombosis
Vomiting

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.
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: April 2016

Reference Sources

Summary of Product Characteristics: Evirex 60 mg film coated tablets. Somex Pharma. Revised August 2014.
Summary of Product Characteristics: Evista 60 mg film-coated tablets. Daiichi Sankyo UK Limited. Revised August 2012.
Summary of Product Characteristics: Ostiral 60 mg film-coated tablets. Lupin (Europe) Ltd. Revised February 2015.
Summary of Product Characteristics: Raloxifene Hydrochloride 60 mg Film-coated Tablets. Actavis UK Ltd. Revised January 2015.
Summary of Product Characteristics: Raloxifene Hydrochloride 60 mg Film-coated Tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised February 2015.
Summary of Product Characteristics: Razylan 60 mg film coated tablets. Aspire Pharma Ltd. Revised December 2014.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 February 2018

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 16 April 2010
Last accessed: 25 April 2016