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. No data is available for febuxostat 120 mg.During the combined phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%). No difference in the proportion of patients requiring treatment for gout flares was observed between the febuxostat 80 mg and 40 mg groups.EXCEL Study (C02-021): The Excel study was a three years Phase 3, open label, multicenter, randomised, allopurinol-controlled, safety extension study for patients who had completed the pivotal Phase 3 studies (APEX or FACT). Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition (see section 5.3). A total of 1,086 patients were enrolled: Febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145). About 69 % of patients required no treatment change to achieve a final stable treatment. No dose adjustment is necessary for warfarin when administered with febuxostat.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.Colchicine has a narrow therapeutic window and is extremely toxic in overdose. In the long-term extension studies the incidences of investigator-reported APTC events were 1.2 and 0.6 events per 100 PYs for febuxostat and allopurinol, respectively. Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity. Hypersensitivity reactions to febuxostat can be associated to the following symptoms: skin reactions characterised by infiltrated maculopapular eruption, generalised or exfoliative rashes, but also skin lesions, facial oedema, fever, haematologic abnormalities such as thrombocytopenia and eosinophilia, and single or multiple organ involvement (liver and kidney including tubulointerstitial nephritis) (see section 4.4).Gout flares were commonly observed soon after the start of treatment and during the first months. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.Colchicine is a substrate for both CYP3A4 and the transport protein P-gp. Prophylaxis against gout flares was obligatory over the 26-week period.The proportion of patients with serum urate levels of < 6.0 mg/dL (357 µmol/L) at the final visit, was 45% for 40 mg febuxostat, 67% for febuxostat 80 mg and 42% for allopurinol 300/200 mg, respectively.The APEX Study evaluated efficacy in 40 patients with renal impairment (i.e., baseline serum creatinine > 1.5 mg/dL and ≤2.0 mg/dL). Tests have shown that colchicine induces chromosomal aberrations and micronuclei, and causes some DNA damage. No data is available for febuxostat 120 mg.Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes. Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects. When suggestions are available use up and down arrows to review and ENTER to select. When starting or up-titrating febuxostat, flare prophylaxis using colchicineor an NSAID is recommended - see Gout preventionsection. Continue typing to refine. All 5 patients with renal impairment had biopsy-proven amyloidosis; 4 were on routine haemodialysis and 1 had a serum creatinine CL of 15 ml/min. Three years in polypropylene or polyethylene tablet containers.
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