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FEBUXOSTAT STADA is a brand name for Febuxostat. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Febuxostat is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Gout The recommended oral dose of Febuxostat is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dl (357 μmol/l) after 2-4 weeks, Febuxostat 120 mg once daily may be considered. Febuxostat works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dl (357 μmol/l). 4). 2). 2). No dose adjustment is necessary in patients with mild or moderate renal impairment. Hepatic impairment The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment. Paediatric population The safety and the efficacy of febuxostat in children aged below the age of 18 years have not been established.
No data are available. Method of administration Oral use Febuxostat should be taken by mouth and can be taken with or without food.
Summary of the safety profile The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg), post-authorisation safety studies (FAST study: 3,001 subjects treated at least with a dose from 80 mg to 120 mg) and post-marketing experience are gout flares, liver function abnormalities, diarrhoea, nausea, headache, dizziness, dyspnoea, rash, pruritus, arthralgia, myalgia, pain in extremity, oedema and fatigue.
These adverse reactions were mostly mild or moderate in severity. Rare serious hypersensitivity reactions to febuxostat, some of which were associated to systemic symptoms and rare events of sudden cardiac death, have occurred in the post-marketing experience.
Tabulated list of adverse reactions Common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000) adverse reactions occurring in patients treated with febuxostat are listed below. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Adverse reactions in combined phase 3, long-term extension studies, post- authorisation safety studies and post-marketing experience Blood and lymphatic system disorders Rare Pancytopenia, thrombocytopenia, agranulocytosis *, anaemia #.
Immune system disorders Rare Anaphylactic reaction*, drug hypersensitivity* Endocrine disorders Uncommon Blood thyroid stimulating hormone increased, hypothyroidism #. Eye disorders Uncommon Blurred vision. Rare Retinal artery occlusion #.
Metabolism and nutrition disorders Common*** Gout flares. Uncommon Diabetes mellitus, hyperlipidaemia, decreased appetite, weight increased. Rare Weight decreased, increased appetite, anorexia. Psychiatric disorders Uncommon Libido decreased, insomnia Rare Nervousness, depressed mood #, sleep disorder #.
g. myocardial infarction, stroke or unstable angina), during the development of the product and in one post registrational study (CARES), a higher number of fatal cardiovascular events were observed with febuxostat when compared to allopurinol.
However, in a subsequent post registrational study (FAST), febuxostat was not inferior to allopurinol in the incidence of both fatal and non-fatal cardiovascular events. Treatment of this patient group should be exercised cautiously and they should be monitored regularly.
1. Medicinal product allergy/hypersensitivity Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson syndrome, toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience.
In most cases, these reactions occurred during the first month of therapy with febuxostat. Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol. Severe hypersensitivity reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) were associated with fever, haematological, renal or hepatic involvement in some cases.
8). Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson syndrome, occur since early withdrawal is associated with a better prognosis. If patient has developed allergic/hypersensitivity reactions including Stevens-Johnson syndrome and acute anaphylactic reaction/shock, febuxostat must not be re-started in this patient at any time.
Acute gouty attacks (gout flare) Febuxostat treatment should not be started until an acute attack of gout has completely subsided. 1). 2). If a gout flare occurs during febuxostat treatment, it should not be discontinued. The gout flare should be managed concurrently as appropriate for the individual patient.
8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Nervous system disorders Common Headache, dizziness. Uncommon Paraesthesia, hemiparesis, somnolence, lethargy #, altered taste, hypoaesthesia, hyposmia Rare Ageusia #, burning sensation #. Ear and labyrinth disorders Uncommon Tinnitus.
Rare Vertigo #. Cardiac disorders Uncommon Atrial fibrillation, palpitations, ECG abnormal, arrhythmia #. Rare Sudden cardiac death* Vascular disorders Uncommon Hypertension, flushing, hot flush. Rare Circulatory collapse #. Respiratory, thoracic and mediastinal disorders Common Dyspnoea.
Uncommon Bronchitis, upper respiratory tract infection, lower respiratory tract infection #, cough, rhinorrhoea #. Rare Pneumonia #.
Gastrointestinal disorders Common Diarrhoea**, nausea Uncommon:
Abdominal pain, abdominal pain upper #, abdominal distension, gastrooesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort, mouth ulceration, lip swelling #, pancreatitis.
Rare Gastrointestinal perforation #, stomatitis #. Hepatobiliary disorders Common Liver function abnormalities**. Uncommon Cholelithiasis. Rare Hepatitis, jaundice*, liver injury*, cholecystitis #. Skin and subcutaneous tissue disorders Common Rash (including various types of rash reported with lower frequencies, see below), pruritus.
Uncommon Dermatitis, urticaria, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular, hyperhidrosis, alopecia, eczema #, erythema, night sweats #, psoriasis #, rash pruritic #. Rare Toxic epidermal necrolysis*, Stevens-Johnson syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms*, generalised rash (serious)*, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash erythematous, rash morbilliform.
Musculoskeletal and connective tissue disorders Common Arthralgia, myalgia, pain in extremity #. Uncommon Arthritis, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis, joint swelling #, back pain #, musculoskeletal stiffness #, joint stiffness.
Rare Rhabdomyolysis*, rotator cuff syndrome #, polymyalgia rheumatica #. Renal and urinary disorders Uncommon Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria, micturition urgency, urinary tract infection #. Rare Tubulointerstitial nephritis*.
Reproductive system and breast disorders Uncommon Erectile dysfunction General disorders and administration site conditions Common Oedema, fatigue. Uncommon Chest pain, chest discomfort, pain #, malaise #. Rare Thirst, feeling hot #.
Investigations Uncommon Blood amylase increased, platelet count decreased, white blood cell count decreased, lymphocyte count decreased, blood creatine increased, blood creatinine increased, haemoglobin decreased, blood urea increased, blood triglycerides increased, blood cholesterol increased, haematocrit decreased, blood lactate dehydrogenase increased, blood potassium increased, international normalised ratio increased #.
Rare Blood glucose increased, activated partial thromboplastin time prolonged, red blood cell count decreased, blood alkaline phosphatase increased, blood creatine phosphokinase increased*. Injury, poisoning and procedural complications Uncommon Contusion #.
* Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
1 for incidences of gout flares in the individual Phase 3 randomised controlled studies. # Adverse reactions coming from post-authorisation safety studies Description of selected adverse reactions Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience.
Stevens-Johnson syndrome and toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation. Hypersensitivity reactions to febuxostat can be associated to the following symptoms: […]
Continuous treatment with febuxostat decreases frequency and intensity of gout flares. g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
As there has been no experience with febuxostat, its use in these populations is not recommended. Mercaptopurine/azathioprine Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity.
3). The patients should be closely monitored and the dose of mercaptopurine/azathioprine should be subsequently adjusted based on the evaluation of the therapeutic response and the onset of eventual toxic effects. 1). 5). Febuxostat 80mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels.
No data is available for febuxostat 120 mg. 0 %). 1). 5 %) in the long term open label extension studies. 1).