Drugs List

Therapeutic Indications

Uses

Carcinoma - prostate

Treatment of advanced prostate cancer, alone or in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy.

Contraindications

Children under 18 years
Elevated serum transaminases - greater than twice the upper limit of normal
Galactosaemia
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Predisposition to fluid retention
Cardiac disorder
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of torsade de pointes
Lactose intolerance
Osteoporosis
Porphyria
Renal impairment

Adjustment of anticoagulant dose may be necessary during concurrent therapy
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
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
Monitor bone mineral density prior to and at least at 1 year post treatment
Monitor hepatic function before, monthly for 4 months, then periodically
Consider non-infectious pneumonitis in patients with respiratory symptoms
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Periodic sperm count determinations may be considered during therapy
Advise patients to discontinue therapy if signs of hepatotoxicity occur
Advise patients to seek medical advice if signs of hepatotoxicity occur
May cause loss of bone mineral density
Potentially hepatotoxic
Reduce dose or discontinue therapy if liver injury or jaundice occurs
Advise patient to avoid alcohol during treatment
Male: Ensure adequate contraception during treatment

In patients who have not received medical or surgical castration, periodic sperm count determinations may be considered during long term treatment. In such patients, flutamide tends to elevate plasma testosterone and estradiol levels.

Pregnancy and Lactation

Pregnancy

Flutamide is not indicated in 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

Flutamide is not indicated in 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

Abdominal pain
Acute renal failure
Anaemia
Anorexia
Anxiety
Arthralgia
Blurred vision
Breast tenderness
Bullous eruption
Cardiovascular disturbances
Chest pain
Cholestatic jaundice
Confusion
Constipation
Cough
Decrease in bone mineral density
Depression
Diarrhoea
Discolouration of urine
Dizziness
Drowsiness
Dyspnoea
Dysuria
Ecchymosis
Epidermal necrolysis
Erythema
Exacerbation of diabetes
Fatigue
Galactorrhoea
Gastro-intestinal symptoms
Gynaecomastia
Haemolytic anaemia
Headache
Heartburn
Hepatic encephalopathy
Hepatic necrosis
Hepatitis
Herpes zoster
Hot flushes
Hyperglycaemia
Hypertension
Impotence
Increase in blood urea nitrogen
Increased appetite
Increased thirst
Insomnia
Interstitial pneumonitis
Jaundice
Leucopenia
Liver function disturbances (reversible)
Lupus erythematosus-like syndrome
Lymphoedema
Macrocytic anaemia
Malaise
Malignant male breast neoplasm
Methaemoglobinaemia
Muscle cramps
Myalgia
Nausea
Nervousness
Oedema
Photosensitivity
Prolongation of QT interval
Pruritus
Rash
Reduced libido
Serum creatinine increased
Spermatogenesis suppression
Sulfaemoglobinaemia
Thrombocytopenia
Ulceration
Urinary frequency
Vomiting
Weakness

Presentation

Flutamide oral formulations

Drugs List

Therapeutic Indications

Uses

Carcinoma - prostate

Treatment of advanced prostate cancer, alone or in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy.

Dosage

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

Doses may vary significantly if this agent is used as monotherapy or different combinations.

Adults

Elderly

Contraindications

Children under 18 years
Elevated serum transaminases - greater than twice the upper limit of normal
Galactosaemia
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Predisposition to fluid retention
Cardiac disorder
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of torsade de pointes
Lactose intolerance
Osteoporosis
Porphyria
Renal impairment

Adjustment of anticoagulant dose may be necessary during concurrent therapy
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
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
Monitor bone mineral density prior to and at least at 1 year post treatment
Monitor hepatic function before, monthly for 4 months, then periodically
Consider non-infectious pneumonitis in patients with respiratory symptoms
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Periodic sperm count determinations may be considered during therapy
Advise patients to discontinue therapy if signs of hepatotoxicity occur
Advise patients to seek medical advice if signs of hepatotoxicity occur
May cause loss of bone mineral density
Potentially hepatotoxic
Reduce dose or discontinue therapy if liver injury or jaundice occurs
Advise patient to avoid alcohol during treatment
Male: Ensure adequate contraception during treatment

In patients who have not received medical or surgical castration, periodic sperm count determinations may be considered during long term treatment. In such patients, flutamide tends to elevate plasma testosterone and estradiol levels.

Pregnancy and Lactation

Pregnancy

Flutamide is not indicated in 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

Flutamide is not indicated in 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

Abdominal pain
Acute renal failure
Anaemia
Anorexia
Anxiety
Arthralgia
Blurred vision
Breast tenderness
Bullous eruption
Cardiovascular disturbances
Chest pain
Cholestatic jaundice
Confusion
Constipation
Cough
Decrease in bone mineral density
Depression
Diarrhoea
Discolouration of urine
Dizziness
Drowsiness
Dyspnoea
Dysuria
Ecchymosis
Epidermal necrolysis
Erythema
Exacerbation of diabetes
Fatigue
Galactorrhoea
Gastro-intestinal symptoms
Gynaecomastia
Haemolytic anaemia
Headache
Heartburn
Hepatic encephalopathy
Hepatic necrosis
Hepatitis
Herpes zoster
Hot flushes
Hyperglycaemia
Hypertension
Impotence
Increase in blood urea nitrogen
Increased appetite
Increased thirst
Insomnia
Interstitial pneumonitis
Jaundice
Leucopenia
Liver function disturbances (reversible)
Lupus erythematosus-like syndrome
Lymphoedema
Macrocytic anaemia
Malaise
Malignant male breast neoplasm
Methaemoglobinaemia
Muscle cramps
Myalgia
Nausea
Nervousness
Oedema
Photosensitivity
Prolongation of QT interval
Pruritus
Rash
Reduced libido
Serum creatinine increased
Spermatogenesis suppression
Sulfaemoglobinaemia
Thrombocytopenia
Ulceration
Urinary frequency
Vomiting
Weakness

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: June 2014

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on June 2, 2014].

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

Summary of Product Characteristics: Flutamide tablets 250mg. Generics UK T/A Mylan. Revised May 2015.

Napos. The drug database for acute porphyria.
Available at https://www.drugs-porphyria.org/languages/UnitedKingdom/s1.php?l=gbr
Flutamide Last revised: July 23, 2010
Last accessed: June 2, 2014