Drugs List

Therapeutic Indications

Uses

Hormone receptor positive, advanced breast cancer in post-menopausal women
Oestrogen receptor positive early invasive breast cancer-adjunctive therapy
Postmenopausal ER+ early breast cancer following 2-3yrs tamoxifen therapy

Treatment of advanced breast cancer in post-menopausal women. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.

Adjunctive treatment of postmenopausal women with oestrogen receptor positive early invasive breast cancer.

Adjuvant treatment for early breast cancer in hormone receptor positive post menopausal women who have received 2 to 3 years of adjuvant tamoxifen treatment.

Unlicensed Uses

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

Prevention of breast cancer (postmenopausal women at moderate to high risk) initiated under specialist supervision.

Contraindications

Galactosaemia

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Osteoporosis
Renal impairment - creatinine clearance below 20ml/minute

Advise impaired alertness may affect ability to drive or operate machinery
Do not use in combination with luteinising hormone release hormone analogue
Not all available brands are licensed for all indications
Contains lactose
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Define menopause biochemically if in doubt about hormonal status
Investigate persistent or recurrent vaginal bleeding
Patients at risk of osteoporosis should have bone density assessed
May cause loss of bone mineral density
Treatment or prophylaxis of osteoporosis should be started as appropriate
In early disease the recommended duration of treatment is 5 years

Women suffering from osteoporosis or at risk of osteoporosis should have their bone density assessed by bone densitometry e.g. DEXA scanning at the initiation of treatment and regularly throughout therapy with anastrozole. Treatment or prophylaxis for osteoporosis should be started as soon as possible and closely monitored. Circulating oestrogen levels are reduced by anastrozole causing a reduction in bone mineral density. Patients may have a higher risk of fracture.

There are uncommon reports of vaginal bleeding mainly in patients with advanced disease in the weeks after changing from existing hormonal therapy to anastrozole treatment. If persistent, further evaluation should be considered.

Pregnancy and Lactation

Pregnancy

Anastrozole has no relevant indication in premenopausal women.

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 14-17 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

Anastrozole has no relevant indication in premenopausal women.

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

Allergic reaction
Anaphylactoid reaction
Angina pectoris
Angioedema
Anorexia
Arthritis
Asthenia
Bone pain
Carpal tunnel syndrome
Cataracts
Cerebrovascular accident
Coronary artery disorder
Cutaneous vasculitis
Decrease in bone mineral density
Deep vein thrombosis (DVT)
Depression
Diarrhoea
Erythema multiforme
Fatigue
Gamma glutamyl transferase (GGT) increased
Hair thinning
Headache
Hepatitis
Hot flushes
Hypercholesterolaemia
Increase in alkaline phosphatase
Increase in serum ALT/AST
Increased risk of fractures
Joint pain
Mood changes
Myocardial infarction
Myocardial ischaemia
Nausea
Osteoporosis
Pulmonary embolism
Rash
Risk of endometrial carcinoma
Serum bilirubin increased
Somnolence
Stevens-Johnson syndrome
Stiffness
Trigger finger
Urticaria
Vaginal bleeding
Vaginal discharge
Vaginal dryness
Vomiting

Presentation

Tablets containing anastrozole

Drugs List

Therapeutic Indications

Uses

Hormone receptor positive, advanced breast cancer in post-menopausal women
Oestrogen receptor positive early invasive breast cancer-adjunctive therapy
Postmenopausal ER+ early breast cancer following 2-3yrs tamoxifen therapy

Treatment of advanced breast cancer in post-menopausal women. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.

Adjunctive treatment of postmenopausal women with oestrogen receptor positive early invasive breast cancer.

Adjuvant treatment for early breast cancer in hormone receptor positive post menopausal women who have received 2 to 3 years of adjuvant tamoxifen treatment.

Unlicensed Uses

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

Prevention of breast cancer (postmenopausal women at moderate to high risk) initiated under specialist supervision.

Dosage

Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

Adults

Patients with Renal Impairment

Contraindications

Galactosaemia

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Osteoporosis
Renal impairment - creatinine clearance below 20ml/minute

Advise impaired alertness may affect ability to drive or operate machinery
Do not use in combination with luteinising hormone release hormone analogue
Not all available brands are licensed for all indications
Contains lactose
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Define menopause biochemically if in doubt about hormonal status
Investigate persistent or recurrent vaginal bleeding
Patients at risk of osteoporosis should have bone density assessed
May cause loss of bone mineral density
Treatment or prophylaxis of osteoporosis should be started as appropriate
In early disease the recommended duration of treatment is 5 years

Women suffering from osteoporosis or at risk of osteoporosis should have their bone density assessed by bone densitometry e.g. DEXA scanning at the initiation of treatment and regularly throughout therapy with anastrozole. Treatment or prophylaxis for osteoporosis should be started as soon as possible and closely monitored. Circulating oestrogen levels are reduced by anastrozole causing a reduction in bone mineral density. Patients may have a higher risk of fracture.

There are uncommon reports of vaginal bleeding mainly in patients with advanced disease in the weeks after changing from existing hormonal therapy to anastrozole treatment. If persistent, further evaluation should be considered.

Pregnancy and Lactation

Pregnancy

Anastrozole has no relevant indication in premenopausal women.

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 14-17 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

Anastrozole has no relevant indication in premenopausal women.

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

Effects on Ability to Drive and Operate Machinery

Advise patients that if affected by side effects such as somnolence, they should not drive or operate machinery.

Side Effects

Allergic reaction
Anaphylactoid reaction
Angina pectoris
Angioedema
Anorexia
Arthritis
Asthenia
Bone pain
Carpal tunnel syndrome
Cataracts
Cerebrovascular accident
Coronary artery disorder
Cutaneous vasculitis
Decrease in bone mineral density
Deep vein thrombosis (DVT)
Depression
Diarrhoea
Erythema multiforme
Fatigue
Gamma glutamyl transferase (GGT) increased
Hair thinning
Headache
Hepatitis
Hot flushes
Hypercholesterolaemia
Increase in alkaline phosphatase
Increase in serum ALT/AST
Increased risk of fractures
Joint pain
Mood changes
Myocardial infarction
Myocardial ischaemia
Nausea
Osteoporosis
Pulmonary embolism
Rash
Risk of endometrial carcinoma
Serum bilirubin increased
Somnolence
Stevens-Johnson syndrome
Stiffness
Trigger finger
Urticaria
Vaginal bleeding
Vaginal discharge
Vaginal dryness
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.

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: January 2013

Reference Sources

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Arimidex 1mg Film-Coated Tablet. AstraZeneca UK Ltd. Revised June 2021.
Summary of Product Characteristics: Anastrozole 1mg film-coated tablets. Accord. Revised March 2012.
Summary of Product Characteristics: Anastrozole tablets. Actavis UK ltd. Revised July 2012.
Summary of Product Characteristics: Anastrozole 1mg film-coated tablets. Medac GmbH. Revised November 2011.
Summary of Product Characteristics: Anastrozole 1mg film-coated tablets. Sandoz. Revised November 2010.
Summary of Product Characteristics: Anastrozole tablets. Zentiva. Revised December 2010.
Summary of Product Characteristics: Nastrosa 1mg film-coated tablets. Discovery Pharmaceuticals. Revised January 2011.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 29 March 2018