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Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Tab is indicated in adults.
Dosage
Gout: The recommended oral dose of Febuxostat is 40 mg once or twice daily without regard to food. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat 120 mg daily may be considered. Febuxostat Tab 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). Gout flare prophylaxis of at least 6 months is recommended.
Elderly: No dose adjustment is required in the elderly
Renal impairment: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 mL/min). No dose adjustment is necessary in patients with mild or moderate renal impairment.
Hepatic impairment: The efficacy and safety of febuxostat have 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 efficacy of Febuxostat Tab in children aged below the age of 18 years have not been established. No data are available.
Directions for Use
For oral use only. Febuxostat ER tablets should be taken by mouth and can be taken with or without food.
The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience in gout patients are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema. These adverse reactions were mostly mild or moderate in severity. Rare serious hypersensitivity reactions to febuxostat, some of which were associated to systemic symptoms, have occurred in the post-marketing experience.
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.
Blood and lymphatic disorders
Rare: Pancytopenia, thrombocytopenia, agranulocytosis*
Immune system disorders
Rare: Anaphylactic reaction*, drug hypersensitivity*
Endocrine disorders
Uncommon: Blood thyroid stimulating hormone increased
Eye disorders
Rare: Blurred vision
Metabolism and nutrition disorders
Common: Gout flares, Uncommon: Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase, Rare: Weight decrease, increase appetite, anorexia
Psychiatric disorders
Uncommon: Libido decreased, insomnia, Rare: Nervousness
Nervous system disorders
Common: Headache, Uncommon: Dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia
Ear and labyrinth disorders
Rare: Tinnitus
Cardiac disorders
Uncommon: Atrial fibrillation, palpitations, ECG abnormal
Vascular disorders
Uncommon: Hypertension, flushing, hot flush
Respiratory, thoracic and mediastinal disorders
Uncommon: Dyspnoea, bronchitis, upper respiratory tract infection, cough
Gastro-intestinal disorders
Common: Diarrhoea, nausea, Uncommon: Abdominal pain, abdominal distension, gastrooesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort, Rare: Pancreatitis, mouth ulceration.
Hepatobiliary disorders
Common: Liver function abnormalities, Uncommon: Cholelithiasis, Rare: Hepatitis, jaundice, liver injury
Skin and subcutaneous tissue disorders
Common: Rash (including various types of rash reported with lower frequencies), Uncommon: Dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash popular, Rare: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, angioedema, drug reaction with eosinophilia and systemic symptoms, generalized rash (serious), erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic, rash erythematous, rash morbillifom, alopecia, hyperhidrosis
Musculoskeletal and connective tissue disorders
Uncommon: Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis. Rare: Rhabdomyolysis, joint stiffness, musculoskeletal stiffness
Renal and urinary disorders
Uncommon: Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria Rare: Tubulointerstitial nephritis, micturition urgency
Reproductive system and breast disorders
Uncommon: Erectile dysfunction
Cardio-vascular disorders
Treatment of chronic hyperuricaemia
Treatment with febuxostat in patients with ischaemic heart disease or congestive heart failure is not recommended.
Medicinal product allergy / hypersensitivity
Rare serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been reported.
Patients should be advised of the signs and symptoms and monitored closely for symptoms of allergic/hypersensitivity reactions.
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 and 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. Gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits.
At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended.
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. Continuous treatment with febuxostat decreases frequency and intensity of gout flares.
Xanthine deposition
As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome isnot 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.
Liver disorders
During the combined phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0 %). Liver function test is recommended prior to the initiation of therapy with febuxostat and periodically thereafter based on clinical judgment.
Thyroid disorders
Increased TSH values (> 5.5 μIU/mL) were observed in patients on long-term treatment with febuxostat (5.5 %) in the long term open label extension studies. Caution is required when febuxostat is used in patients with alteration of thyroid function.
Organ transplant recipients
As there has been no experience in organ transplant recipients, the use of febuxostat in such patients is not recommended.
Lactose
Febuxostat Tabs contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
3 x 10 Alu/PVC blister pack Febuxostat Extended Release Tablets ( GOTA 80ER) is available in an Alu/PVC blister of 10 tablets. Such 03 blisters in a unit carton with package insert.
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