Drugs List

Therapeutic Indications

Uses

Advanced prostate cancer with LHRH analogue or surgical castration
Locally advanced non metastatic prostate cancer(other treatment unsuitable)
Locally advanced prostate cancer at high risk of disease progression

Locally advanced prostate cancer in patients at a high risk of disease progress, either as monotherapy or an adjuvant treatment to radical prostatectomy or radiotherapy.

Locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.

Advanced prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration.

Unlicensed Uses

Metastatic prostate cancer: Retaining sexual function

Retaining sexual function in patients with metastatic prostate cancer.

Contraindications

Children under 18 years
Females
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Lactose intolerance
Moderate hepatic impairment

Correct electrolyte disorders before treatment
CSM (CHM) - not for treatment of localised prostate cancer
Advise ability to drive/operate machinery may be affected by side effects
Not all presentations are licensed for all indications
Treatment to be initiated and supervised by a specialist
Some formulations contain lactose
Monitor ECG in patients at risk of QT prolongation
Monitor hepatic function regularly
Monitor prothrombin times closely in patients on anticoagulant therapy
Monitor serum electrolytes
Consider discontinuing therapy in disease progression + raised PSA
Discontinue if severe hepatic changes occur
Male: Contraception required during and for 5 months after treatment
Partner: Contraception required during and for 5 months after treatment
Advise patient to avoid exposure to sunlight and UV rays during treatment

In males receiving LHRH agonists a reduction in glucose tolerance has been observed. This may present itself as diabetes or loss of glycaemic control in those with pre-existing diabetes. Consideration should be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists.

Pregnancy and Lactation

Pregnancy

Bicalutamide is contraindicated in women.

There are no data available on the use of bicalutamide during pregnancy, as bicalutamide is only indicated for use in men. Bicalutamide must not be given to pregnant 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 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

Bicalutamide is contraindicated in women.

There are no data available on the use of bicalutamide during breastfeeding, as bicalutamide is only indicated for use in men. Bicalutamide must not be given to women during breastfeeding.

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
Alopecia
Anaemia
Angina
Angioneurotic oedema
Anorexia
Arrhythmias
Asthenia
Breast tenderness
Cardiac failure
Chest pain
Cholestasis
Constipation
Decreased appetite
Depression
Diabetes mellitus
Diarrhoea
Dizziness
Dry skin
Dyspepsia
ECG changes
Erectile dysfunction
Flatulence
Gynaecomastia
Haematuria
Hair regrowth
Headache
Hepatic failure
Hepatotoxicity
Hirsutism
Hot flushes
Hyperglycaemia
Hypersensitivity reactions
Impotence
Increase in serum transaminases
Interstitial lung disease
Jaundice
Liver function disturbances
Myocardial infarction
Nausea
Oedema
Photosensitivity
Prolongation of QT interval
Pruritus
Pulmonary fibrosis
Rash
Reduced libido
Somnolence
Thrombocytopenia
Urticaria
Weight gain

Presentation

Oral formulations of bicalutamide.

Drugs List

Therapeutic Indications

Uses

Advanced prostate cancer with LHRH analogue or surgical castration
Locally advanced non metastatic prostate cancer(other treatment unsuitable)
Locally advanced prostate cancer at high risk of disease progression

Locally advanced prostate cancer in patients at a high risk of disease progress, either as monotherapy or an adjuvant treatment to radical prostatectomy or radiotherapy.

Locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.

Advanced prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration.

Unlicensed Uses

Metastatic prostate cancer: Retaining sexual function

Retaining sexual function in patients with metastatic prostate cancer.

Dosage

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

Adults

Contraindications

Children under 18 years
Females
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Lactose intolerance
Moderate hepatic impairment

Correct electrolyte disorders before treatment
CSM (CHM) - not for treatment of localised prostate cancer
Advise ability to drive/operate machinery may be affected by side effects
Not all presentations are licensed for all indications
Treatment to be initiated and supervised by a specialist
Some formulations contain lactose
Monitor ECG in patients at risk of QT prolongation
Monitor hepatic function regularly
Monitor prothrombin times closely in patients on anticoagulant therapy
Monitor serum electrolytes
Consider discontinuing therapy in disease progression + raised PSA
Discontinue if severe hepatic changes occur
Male: Contraception required during and for 5 months after treatment
Partner: Contraception required during and for 5 months after treatment
Advise patient to avoid exposure to sunlight and UV rays during treatment

In males receiving LHRH agonists a reduction in glucose tolerance has been observed. This may present itself as diabetes or loss of glycaemic control in those with pre-existing diabetes. Consideration should be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists.

Pregnancy and Lactation

Pregnancy

Bicalutamide is contraindicated in women.

There are no data available on the use of bicalutamide during pregnancy, as bicalutamide is only indicated for use in men. Bicalutamide must not be given to pregnant 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 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

Bicalutamide is contraindicated in women.

There are no data available on the use of bicalutamide during breastfeeding, as bicalutamide is only indicated for use in men. Bicalutamide must not be given to women during breastfeeding.

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
Alopecia
Anaemia
Angina
Angioneurotic oedema
Anorexia
Arrhythmias
Asthenia
Breast tenderness
Cardiac failure
Chest pain
Cholestasis
Constipation
Decreased appetite
Depression
Diabetes mellitus
Diarrhoea
Dizziness
Dry skin
Dyspepsia
ECG changes
Erectile dysfunction
Flatulence
Gynaecomastia
Haematuria
Hair regrowth
Headache
Hepatic failure
Hepatotoxicity
Hirsutism
Hot flushes
Hyperglycaemia
Hypersensitivity reactions
Impotence
Increase in serum transaminases
Interstitial lung disease
Jaundice
Liver function disturbances
Myocardial infarction
Nausea
Oedema
Photosensitivity
Prolongation of QT interval
Pruritus
Pulmonary fibrosis
Rash
Reduced libido
Somnolence
Thrombocytopenia
Urticaria
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: April 2018

Reference Sources

Summary of Product Characteristics: Bicalutamide 50mg film coated tablets. Teva. Revised October 2015 .

Summary of Product Characteristics: Bicalutamide 150mg film coated tablets. Teva. Revised October 2015.

Summary of Product Characteristics: Casodex tablets 150mg. AstraZeneca. Revised February 2018 .

Summary of Product Characteristics: Casodex tablets 50mg. AstraZeneca. Revised February 2018.

MHRA 28th October 2003
https://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON2015691
Last accessed: November 8, 2011

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 April 2018