Drugs List

Therapeutic Indications

Uses

Chronic hyperuricaemia where urate deposition has already occurred

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of tophus and/or gouty arthritis).

Contraindications

Children under 18 years
Organ transplant recipients
Breastfeeding
Galactosaemia
Pregnancy
Severe cardiovascular disorder

Precautions and Warnings

Congestive cardiac failure
Glucose-galactose malabsorption syndrome
Hepatic impairment
Ischaemic heart disease
Lactose intolerance
Lesch-Nyhan syndrome
Renal impairment - creatinine clearance below 30 ml/minute
Thyroid dysfunction

Do not initiate during an acute attack of gout
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Perform liver function tests before commencing therapy and during therapy
Monitor for signs and symptoms of allergic reaction
Advise patient to report symptoms of allergic type hypersensitivity
Suspend treatment if Stevens-Johnson syndrome is suspected
Discontinue permanently if severe hypersensitivity reactions occur

If a gout flare occurs during treatment, it should not be discontinued. The gout flare should be managed concurrently as appropriate for the patient. Continuous treatment with febuxostat decreases the frequency and intensity of gout flares.

Patients should be advised of the signs and symptoms of severe hypersensitivity; febuxostat must be stopped immediately if these occur, and must not be restarted in patients who have ever developed a hypersensitivity reaction to febuxostat. Most cases occur during the first month of treatment; a prior history of hypersensitivity to allopurinol and or renal disease may indicate potential hypersensitivity to febuxostat.

Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease, unless no other therapy options are appropriate.

Pregnancy and Lactation

Pregnancy

Febuxostat is contraindicated during pregnancy.

Use of febuxostat during pregnancy is contraindicated by the manufacturer. Available reports indicate no increased risk of teratogenic or development effects. However, human data is limited and as such a potential risk cannot be ruled out.

Lactation

Febuxostat is contraindicated during breastfeeding.

Use of febuxostat when breastfeeding is contraindicated by the manufacturer. Animal data reports significant levels of febuxostat in the breast milk, however presence in human breast milk is unknown. The effects on exposed infants are unknown.

Side Effects

Abdominal distension
Abdominal pain
Alopecia
Altered thyroid hormone levels
Anaphylactic shock
Angioedema
Anorexia
Arthralgia
Arthritis
Atrial fibrillation
Blood urea increased
Blurred vision
Bronchitis
Bursitis
Chest pain
Cholelithiasis
Constipation
Cough
Creatine kinase increased
Dermatitis
Diabetes
Diarrhoea
Disturbances of appetite
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
ECG changes
Elevated amylase levels
Elevated serum potassium
Elevated triglyceride levels
Elevated TSH
Erectile dysfunction
Erythema
Fatigue
Flatulence
Flushing
Gastro-intestinal discomfort
Gastroesophageal reflux disease
Gout flare
Haematuria
Haemoglobin decrease
Headache
Hemiparesis
Hepatitis
Hot flushes
Hyperglycaemia
Hyperhidrosis
Hyperlipidaemia
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in plasma cholesterol
Increase in serum glucose
Increased partial thromboplastin time
Insomnia
Jaundice
Liver function disturbances
Muscle weakness
Muscular cramps
Musculoskeletal pain
Myalgia
Nausea
Nephritis
Nephrolithiasis
Nervousness
Oedema
Oral ulceration
Palpitations
Pancreatitis
Pancytopenia
Paraesthesia
Pollakiuria
Proteinuria
Pruritus
Rash
Reduced libido
Reduced lymphocyte count
Reduced platelet count
Renal failure
Rhabdomyolysis
Serum creatinine increased
Skin discolouration
Skin lesions
Smelling disturbances
Somnolence
Stevens-Johnson syndrome
Stiffness
Taste disturbances
Thirst
Tinnitus
Upper respiratory tract infection
Urinary urgency
Urticaria
Vomiting
Weight changes
White blood cell count decreased

Presentation

Oral formulations of febuxostat.

Drugs List

Therapeutic Indications

Uses

Chronic hyperuricaemia where urate deposition has already occurred

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of tophus and/or gouty arthritis).

Dosage

Adults

Patients with Hepatic Impairment

Additional Dosage Information

Contraindications

Children under 18 years
Organ transplant recipients
Breastfeeding
Galactosaemia
Pregnancy
Severe cardiovascular disorder

Precautions and Warnings

Congestive cardiac failure
Glucose-galactose malabsorption syndrome
Hepatic impairment
Ischaemic heart disease
Lactose intolerance
Lesch-Nyhan syndrome
Renal impairment - creatinine clearance below 30 ml/minute
Thyroid dysfunction

Do not initiate during an acute attack of gout
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Perform liver function tests before commencing therapy and during therapy
Monitor for signs and symptoms of allergic reaction
Advise patient to report symptoms of allergic type hypersensitivity
Suspend treatment if Stevens-Johnson syndrome is suspected
Discontinue permanently if severe hypersensitivity reactions occur

If a gout flare occurs during treatment, it should not be discontinued. The gout flare should be managed concurrently as appropriate for the patient. Continuous treatment with febuxostat decreases the frequency and intensity of gout flares.

Patients should be advised of the signs and symptoms of severe hypersensitivity; febuxostat must be stopped immediately if these occur, and must not be restarted in patients who have ever developed a hypersensitivity reaction to febuxostat. Most cases occur during the first month of treatment; a prior history of hypersensitivity to allopurinol and or renal disease may indicate potential hypersensitivity to febuxostat.

Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease, unless no other therapy options are appropriate.

Pregnancy and Lactation

Pregnancy

Febuxostat is contraindicated during pregnancy.

Use of febuxostat during pregnancy is contraindicated by the manufacturer. Available reports indicate no increased risk of teratogenic or development effects. However, human data is limited and as such a potential risk cannot be ruled out.

Lactation

Febuxostat is contraindicated during breastfeeding.

Use of febuxostat when breastfeeding is contraindicated by the manufacturer. Animal data reports significant levels of febuxostat in the breast milk, however presence in human breast milk is unknown. The effects on exposed infants are unknown.

Side Effects

Abdominal distension
Abdominal pain
Alopecia
Altered thyroid hormone levels
Anaphylactic shock
Angioedema
Anorexia
Arthralgia
Arthritis
Atrial fibrillation
Blood urea increased
Blurred vision
Bronchitis
Bursitis
Chest pain
Cholelithiasis
Constipation
Cough
Creatine kinase increased
Dermatitis
Diabetes
Diarrhoea
Disturbances of appetite
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
ECG changes
Elevated amylase levels
Elevated serum potassium
Elevated triglyceride levels
Elevated TSH
Erectile dysfunction
Erythema
Fatigue
Flatulence
Flushing
Gastro-intestinal discomfort
Gastroesophageal reflux disease
Gout flare
Haematuria
Haemoglobin decrease
Headache
Hemiparesis
Hepatitis
Hot flushes
Hyperglycaemia
Hyperhidrosis
Hyperlipidaemia
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in plasma cholesterol
Increase in serum glucose
Increased partial thromboplastin time
Insomnia
Jaundice
Liver function disturbances
Muscle weakness
Muscular cramps
Musculoskeletal pain
Myalgia
Nausea
Nephritis
Nephrolithiasis
Nervousness
Oedema
Oral ulceration
Palpitations
Pancreatitis
Pancytopenia
Paraesthesia
Pollakiuria
Proteinuria
Pruritus
Rash
Reduced libido
Reduced lymphocyte count
Reduced platelet count
Renal failure
Rhabdomyolysis
Serum creatinine increased
Skin discolouration
Skin lesions
Smelling disturbances
Somnolence
Stevens-Johnson syndrome
Stiffness
Taste disturbances
Thirst
Tinnitus
Upper respiratory tract infection
Urinary urgency
Urticaria
Vomiting
Weight changes
White blood cell count decreased

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: August 2019

Reference Sources

Summary of Product Characteristics: Adenuric 80mg film-coated tablets. A.Menarini Pharma U.K. S.R.L. Revised July 2019.
Summary of Product Characteristics: Adenuric 120mg film-coated tablets. A.Menarini Pharma U.K. S.R.L. Revised July 2019.
Summary of Product Characteristics: Febuxostat 80mg film-coated tablets. Accord UK Ltd. Revised September 2018.
Summary of Product Characteristics: Febuxostat 120mg film-coated tablets. Accord UK Ltd. Revised September 2018.
Summary of Product Characteristics: Febuxostat 80mg film-coated tablets. Dr Reddy's Laboratories (UK) Ltd. Revised February 2019.
Summary of Product Characteristics: Febuxostat 120mg film-coated tablets. Dr Reddy's Laboratories (UK) Ltd. Revised February 2019.

MHRA Drug Safety Update July 2019
Available at: https://www.mhra.gov.uk
Last accessed: 07 August 2019