Febuxostat Sandoz

Chronic hyperuricaemia in conditions where urate deposition has already occurred (including history, or presence of, tophus &/or gouty arthritis). Prevention & treatment of hyperuricaemia in adults undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (TLS).

Gout 80 mg once daily. Serum uric acid >6 mg/dL (357 μmol/L) after 2-4 wk May increase dose to 120 mg once daily. TLS 120 mg once daily. Start 2 days before beginning of cytotoxic therapy & continue for min of 7 days, & may be prolonged up to 9 days according to chemotherapy duration. Mild hepatic impairment 80 mg.

May be taken with or without food.

Hypersensitivity.

Discontinue treatment immediately if serious allergic/hypersensitivity reaction including SJS occur & not to be restarted at any time. SJS, TEN & acute anaphylactic reaction/shock; DRESS associated w/ fever, haematological, renal or hepatic involvement. Closely monitor patients for symptoms of allergic/hypersensitivity reactions. Not to be started until acute attack of gout has completely subsided. Not recommended to use in patients w/ Lesch-Nyhan syndrome; organ transplant recipients; patients concomitantly treated w/ mercaptopurine/azathioprine. Gout flares may occur during treatment initiation. Mild LFT abnormalities. Increased TSH values (>5.5 μIU/mL) on long-term treatment. Patients w/ pre-existing major CV diseases (eg, MI, stroke or unstable angina); thyroid function alteration. Consider flare prophylaxis for at least 6 mth w/ NSAID or colchicine at treatment initiation. Perform LFT prior to therapy & periodically thereafter. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ mercaptopurine/azathioprine. May impair ability to drive & use machines. Severe renal (CrCl <30 mL/min) & hepatic (Child Pugh Class C) impairment. Not to be used during pregnancy & lactation. Childn <18 yr.

Gout flares; headache, dizziness; dyspnoea; diarrhoea, nausea; liver function abnormalities; rash, pruritus; arthralgia, myalgia, pain in extremity; oedema, fatique. TEN, SJS, DRESS.

Increased plasma conc of mercaptopurine/azathioprine. Increased exposure w/ naproxen. Increased metabolism & decreased efficacy w/ potent UGT inducers. Increased AUC of desipramine (CYP2D6 substrate). Delayed absorption & decreased C_max w/ antacid containing Mg & Al hydroxide.

Hyperuricemia & Gout Preparations

M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.

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