febuxostat al 80 mg

Maximum dosage: 80 mg … The proportion of patients with serum urate levels of <6.0 mg/dL (357 µmol/L) at the final visit was greater than 80% (81-100%) at each febuxostat dose. For ULORIC 80 mg, 1377 patients were treated for ≥6 months, 674 patients were treated for ≥1 year and 515 patients were treated for ≥2 years. It is written for patients and gives information about taking or using a medicine. There were no clinically significant differences in the percent decrease in serum uric acid concentration in healthy subjects irrespective of their renal function (58% in the normal renal function group and 55% in the severe renal dysfunction group). Two studies compared the efficacy and safety of febuxostat with allopurinol and 1 study compared with benzbromarone. It is generally recommended only for people who cannot take allopurinol. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. more than 96% of patients did not require treatment for a flare) at Month 16-24 and at Month 30-36. The mean total AUC of febuxostat increased by approximately 1.8-fold from 7.5 μgh/mL in the normal renal function group to 13.2 μg.h/mL in the severe renal dysfunction group. Rare serious hypersensitivity reactions to febuxostat, some of which were associated to systemic symptoms, have occurred in the post-marketing experience. FACT study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for a gout flare compared to both the febuxostat 80 mg (22%) and allopurinol 300 mg (21%) treatment groups. Continue, 2. The effect of Febuxostat on human fertility is unknown. Drug interaction studies of febuxostat with other cytotoxic chemotherapy have not been conducted. PVC/PCTFE – Aluminium blister of 14 tablets. Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience, Pancytopenia, thrombocytopenia, agranulocytosis*, Anaphylactic reaction*, drug hypersensitivity*, Blood thyroid stimulating hormone increased, Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase, Weight decrease, increase appetite, anorexia, Dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia, Atrial fibrillation, palpitations, ECG abnormal, Dyspnoea, bronchitis, upper respiratory tract infection, cough, Abdominal pain, abdominal distension, gastro-oesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort, Rash (including various types of rash reported with lower frequencies, see below), Dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular, 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, Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis, Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness, Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria, Tubulointerstitial nephritis*, micturition urgency, General disorders and administration site conditions, Blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocritic decrease, blood lactate dehydrogenase increased, blood potassium increase, Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase*, * Adverse reactions coming from post-marketing experience. 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). In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3). An interaction study in healthy subjects has been performed with febuxostat to evaluate whether the inhibition of XO may cause an increase in the theophylline circulating levels as reported with other XO inhibitors. These findings are considered a consequence of species specific purine metabolism and urine composition and of no relevance to clinical use. 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. If a gout flare occurs during febuxostat treatment, it should not be discontinued. Take febuxostat exactly as your doctor tells you to. Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1). Absolute bioavailability of the febuxostat tablet formulation has not been studied. If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, Febuxostat 120 mg once daily may be considered. Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson-Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience. The tablet should be swallowed with water. Febuxostat compared with allopurinol in patients with hyperuricemia and gout N Engl J Med. 30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR. In the 11 included trials, febuxostat dosage in the treatment group ranged from 10 to 80 mg/day. These gout flares may be prevented with non-steroidal anti-inflammatory drugs (for example, indomethacin [Indocin, Indocin-SR]) or colchicine. Gout flares during the last 4 weeks of the study (Weeks 24-28) were observed in 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) and 20% (placebo) of subjects. An analysis in patients with gout and renal impairment was prospectively defined in the CONFIRMS study, and showed that febuxostat was significantly more efficacious in lowering serum urate levels to < 6 mg/dL compared to allopurinol 300 mg/200 mg in patients who had gout with mild to moderate renal impairment (65% of patients studied). Effects in non-clinical studies were generally observed at exposures in excess of the maximum human exposure. Naomi Schlesinger MD, in Gout, 2019. Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro. In febuxostat 40 mg, febuxostat 80 mg, and allopurinol groups, primary endpoint was achieved in 45%, 67%, and 42%, respectively. It is taken by mouth. Sie sollten deswegen generell vor der Behandlung mit einem neuen … Febuxostat lowers uric acid. Gout flare prophylaxis is recommended (see section 4.2 and 4.4). Patients should be advised of the signs and symptoms and monitored closely for symptoms of allergic/hypersensitivity reactions (see section 4.8). 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%). Teratology studies, performed in pregnant rats at approximately 4.3 times and pregnant rabbits at approximately 13 times human exposure did not reveal any teratogenic effects. Febuxostat works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. Primary endpoint in the sub-group of patients with renal impairment. Take one tablet each day. Was sollten Sie beachten? Mild to moderate (CrCl 30-89 mL/min): No dosage adjustment necessary ; Severe (CrCl ; 30 mL/min): Not to exceed 40 mg/day Hepatic impairment. Febuxostat, at doses of 80 mg and 120 mg, is indicated for treatment of chronic hyperuricaemia in conditions where urate deposition has … Febuxostat has an apparent mean terminal elimination half-life (t1/2) of approximately 5 to 8 hours. A standard battery of test for genotoxicity did not reveal any biologically relevant genotoxic effects for febuxostat. Prophylaxis against gout flares was obligatory over the 26-week period. Initially 80 mg once daily, if after 2–4 weeks of initial dose, serum uric acid greater than 6 mg/100 mL then increase dose; increased if necessary to 120 mg once daily. Report Side Effect; Related Medicines. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. FACT Study: The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study. However, no clinically significant change in the percent decrease in serum uric acid concentration was observed where tested (80 mg multiple dose). Three years data showed a decrease in the incidence of gout flares with less than 4% of patients requiring treatment for a flare (i.e. Desipramine/CYP2D6 substrates. 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). No dose adjustment is necessary for warfarin when administered with febuxostat. 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. INR and Factor VII activity were also not affected by the co- administration of febuxostat. On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended. After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.0-5.3 µg/mL, respectively. Based on modelling and simulation analysis of data from a pre-clinical study in rats, when coadministered with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.5 and 5.3). May increase to 80 mg PO qDay after 2 wk if serum uric acid . Usually you’ll start with 80 mg daily, but your doctor will take regular blood tests and may increase the dose to 120 mg daily if your blood urate level doesn’t come down far enough for the crystals to dissolve. Started with 40 mg and had small attacks like every two months or so. In healthy subjects, maximum plasma concentrations (Cmax) and area under the plasma concentration time curve (AUC) of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg to 120 mg. For doses between 120 mg and 300 mg, a greater than dose proportional increase in AUC is observed for febuxostat. 46% and 38%, of patients on final stable treatment of febuxostat 80 or 120 mg QD, respectively, had complete resolution of the primary palpable tophus from baseline to the Final Visit. Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition (see section 5.3). In a post-market CV outcome study (the CARES trial),1 a higher rate of CV fatal outcomes has been reported in patients with gout and established cardiovascular disease treated with ULORIC, when compared to those treated with allopurinol (see Background section for more details). 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. Any unused medicinal product or waste material should be disposed of in accordance with local requirements, 30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR. Went to 80 mg and have had no attacks. Febuxostat, sold under the brand names Uloric and Adenuric among others, is a medication used long-term to treat gout due to high uric acid levels. 509 patients received allopurinol 300 mg QD; 10 patients with serum creatinine >1.5 and < 2.0 mg/dL were dosed with 100 mg QD. Qualitative und quantitative Zusammensetzung Jede Filmtablette enthält 80 mg Febuxostat als Hemihydrat. I did run a gout fever cold/sweat/shakes which my Dr. Oral Cancer therapy-induced hyperuricaemia. The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average post-baseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20-Week 24 to Week 49 - 52 intervals). We searched the MEDLINE and … If the serum urate is > 0.36 mmol/L, increase the dose of febuxostat to 120 mg* once daily, aiming for a serum urate of < 0.36 mmol/L. Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects. Crude rates of incident renal disease per 1000 person-years were lower with higher daily dose: allopurinol <200, 200–299 and ≥300 mg/day with 238, 176 and 155; and febuxostat 40 and 80 mg/day with 341 and 326, respectively. In propensity-matched analyses, compared with febuxostat, allopurinol use was associated with lower HR of incident renal disease, 0.61 (95% CI 0.49 to 0.77). Hinweise zu den Bereichen Allergien (betreffend Wirk- und Hilfsstoffe), Komplikationen mit Nahrungs- und Genussmitteln, sowie sonstige Warnhinweise. In Phase 2 and 3 clinical studies, a total of 2757 patients with hyperuricemia and gout were treated with ULORIC 40 mg or 80 mg daily. In a study in healthy subjects, 120 mg Febuxostat QD resulted in a mean 22% increase in AUC of desipramine, a CYP2D6 substrate indicating a potential weak inhibitory effect of febuxostat on the CYP2D6 enzyme in vivo. Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with febuxostat 40-240 mg QD. CONFIRMS Study: The CONFIRMS study was a Phase 3, randomized, controlled, 26-week study to evaluate the safety and efficacy of febuxostat 40 mg and 80 mg, in comparison with allopurinol 300 mg or 200 mg, in patients with gout and hyperuricaemia. The Cmax and AUC of active metabolites increased up to 2- and 4-fold, respectively. Clinical Outcomes: proportion of patients requiring treatment for a gout flare. Hira D. Chisaki Y. Noda S. et al. It may be administered with or without food, and it can be taken with antacids. There was no evidence of impaired fertility, teratogenic effects, or harm to the foetus due to febuxostat. Febuxostat should be taken by mouth and can be taken with or without food. Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of Febuxostat. OUTCOME MEASURES: Discounted costs, discounted quality-adjusted life-years, and incremental cost … To view the changes to a medicine you must sign up and log in. 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. INR and Factor VII activity were also not affected by the co-administration of febuxostat. Febuxostat 40 mg UL was statistically non-inferior to allopurinol, but febuxostat 80 mg was superior to both (P < 0.001). APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study. INR and Factor VII activity were also not affected by the co- administration of febuxostat. Back to top. During the phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%). Description of selected adverse reactions. The recommended oral dose of Febuxostat is 80 mg once daily without regard to food. Thus, Febuxostat may be taken without regard to food. No dose adjustment is required in the elderly (see section 5.2). In patients in whom the rate of urate formation is greatly increased (e.g. Both steps in the above transformations are catalyzed by xanthine oxidase (XO). Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro. Febuxostat achieved the primary efficacy endpoint in 44% (80 mg QD), 45% (120 mg QD), and 60% (240 mg QD) of patients compared to 0% in the allopurinol 100 mg QD and placebo groups. No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C). APEX study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%). Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) were associated with fever, haematological, renal or hepatic involvement in some cases. During the CONFIRMS study, the percentages of patients who required treatment for gout flares (Day 1 through Month 6) were 31% and 25% for the febuxostat 80 mg and allopurinol groups, respectively. In this double‐blind, placebo‐controlled study, 314 subjects with hyperuricemia (serum uric acid [UA] level of ≥7.0 mg/dl) and early gout were randomized 1:1 to receive once‐daily febuxostat 40 mg (increased to 80 mg if the serum UA level was ≥6.0 mg/dl on day 14) or placebo. The ability of febuxostat to lower serum uric acid levels was prompt and persistent. Patients in the febuxostat group were given febuxostat orally (80 mg and 120 mg tablets; Patheon France [Bourgoin Jallieu, France] or Menarini [Dresden, Germany]) at 80 mg daily for the first 2 weeks after randomisation. By continuing to browse the site you are agreeing to our policy on the use of cookies. No dose adjustment is necessary in patients with mild or moderate renal impairment. Febuxostat AL 80 mg Filmtabletten 2. The plasma protein binding of febuxostat is approximately 99.2%, (primarily to albumin), and is constant over the concentration range achieved with 80 and 120 mg doses. Potent inducers of UGT enzymes might possibly lead to increased metabolism and decreased efficacy of febuxostat. … In November 2017 the FDA released a warning alert on a possible link between febuxostat and cardiovascular disease (CVD) reported in a single clinical trial.Objective. For febuxostat 80 mg and 120 mg, patients were 68.9 and 80.7 times more likely to achieve serum uric acid levels < 6.0 mg/dL at their final visit compared to placebo (95% CI 13.8 to 343.9, 95% CI 16.0 to 405.5), respectively; with an absolute treatment benefit of 75% and 87% (95% CI 68 to 80% and 81 to 91%), respectively. Stevens-Johnson-Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation. When starting the treatment, your doctor will give you 80 mg strength tablets. 4.5). By mouth. Population pharmacokinetics and therapeutic efficacy of febuxostat in patients with severe renal impairment. In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors was not related to any clinically significant increase in adverse events. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8). How it should be taken : It comes as a tablet to take by mouth with or without food. 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. Pharmacology. Approximately 40% of patients (combined APEX and FACT) had a baseline sUA of ≥ 10 mg/dL. Start febuxostat at 80 mg once daily. Febuxostat contains sodium. 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). Conversely, cessation of treatment of an inducer might lead to increased plasma levels of febuxostat. Background. At least 65% of the patients had mild-moderate renal impairment (with creatinine clearance of 30-89 mL/min). Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn. Carcinogenesis, mutagenesis, impairment of fertility. The apparent steady state volume of distribution (Vss/F) of febuxostat ranges from 29 to 75 L after oral doses of 10-300 mg. The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 µmol/L). Febuxostat, at a daily dose of 80 mg or 120 mg, was more effective than allopurinol at the commonly used fixed daily dose of 300 mg in lowering serum urate. 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. When suggestions are available use up and down arrows to review and ENTER to select. These adverse reactions were mostly mild or moderate in severity. Each tablet contains either 80 mg or 120 mg of febuxostat. Following multiple doses of 80 mg of febuxostat in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function. 62% of patients required no dose adjustment to maintain sUA <6 mg/dL and 38% of patients required a dose adjustment to achieve a final stable dose. Gout flares during the last 4 weeks of the study (Weeks 49-52) were observed in 6-8% (febuxostat 80 mg, 120 mg) and 11% (allopurinol 300 mg) of subjects. The safety and the efficacy of Febuxostat in children aged below the age of 18 years have not been established. As there has been no experience with febuxostat, its use in these populations is not recommended. Prophylaxis and treatment of acute hyperuricaemia with initial chemotherapy for haematologic malignancies . After the 8-week prophylaxis period, the incidences of flares increased and gradually decreased over time (64% and 70% of subjects received treatment for gout flares from Week 8-52). Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro. Interestingly, both patients who stopped febuxostat due to adverse events were undergoing PD and their febuxostat doses were 40 and 80 mg/d, respectively. 116 patients were enrolled and received initially febuxostat 80 mg QD. 2015; 96: 90-98. Gout flares were commonly observed soon after the start of treatment and during the first months. Pharmacotherapeutic group: Antigout preparation, preparations inhibiting uric acid production, ATC code: M04AA03. Seven hundred sixty (760) patients were randomized: febuxostat 80 mg QD (n=256), febuxostat 120 mg QD (n=251), or allopurinol 300 mg QD (n=253). By continuing to browse the site you are agreeing to our policy on the use of cookies. 3. Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes. PVC/PVDC – Aluminium blister of 14 tablets. Serum urate levels were maintained over time (i.e. 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. Febuxostat is eliminated by both hepatic and renal pathways. Febuxostat has been shown to potently inhibit both the oxidized and reduced forms of XO. No data is available regarding the safety of febuxostat during other cytotoxic therapy. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. After 2 weeks, serum urate concentration was measured and, if not controlled to the EULAR target, the febuxostat dose was increased to 120 mg daily. Common side effects of Febuxostat : Upset stomach or throwing up. The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C). Where the combination cannot be avoided, a reduction of the dose of mercaptopurine/azathioprine is recommended. Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Febuxostat does not adversely affect performance. Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol. Febuxostat at oral doses up to 48 mg/kg/day was found to have no effect on fertility and reproductive performance of male and female rats. 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 are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema. No difference in the proportion of patients requiring treatment for gout flares was observed between the febuxostat 80 mg and 40 mg groups. Febuxostat treatment should not be started until an acute attack of gout has completely subsided. When initially started, medications such as NSAIDs are often recommended to prevent gout flares. Monitoring of serum uric acid is therefore recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation. Data on a very limited number of exposed pregnancies have not indicated any adverse effects of febuxostat on pregnancy or on the health of the foetus/new born child. Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed. *** See section 5.1 for incidences of gout flares in the individual Phase 3 randomized controlled studies. The FACT study showed the statistically significant superiority of both febuxostat 80 mg and febuxostat 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 µmol/L). May increase dose to 120 mg once daily if serum uric acid is >6 mg/dL after 2-4 weeks.

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