adenuric 120 mg

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. See section 4. Primary endpoints were serum uric acid area under the curve (AUC sUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8. 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. There was no significant increase in any other tumour type in either male or female mice or rats. How to take ADENURIC No interaction studies have been performed in humans. Febuxostat can be co-administered with naproxen with no dose adjustment of febuxostat or naproxen being necessary. In a study in healthy subjects, coadministration of 120 mg febuxostat QD with a single 4 mg oral dose of rosiglitazone had no effect on the pharmacokinetics of rosiglitazone and its metabolite N-desmethyl rosiglitazone, indicating that febuxostat is not a CYP2C8 enzyme inhibitor in vivo. Pharmacokinetic modelling and simulation of rat data suggests that, when co-administered with febuxostat, the clinical dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.4 and 4.5). Overall 56.6% of patients discontinued trial treatment prematurely and 45% of patients did not complete all trial visits. Where the combination cannot be avoided, a reduction of the dose of mercaptopurine/azathioprine is recommended. APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study. Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol. Marketing Authorisation Holder and Manufacturer. 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. Continue typing to refine. Adenuric est un médicament qui contient le principe actif fébuxostat. 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 80 mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels. It allows continued monitoring of the benefit/risk balance of the medicinal product. 240 mg febuxostat was used to evaluate the safety of febuxostat at twice the recommended highest dose. Febuxostat is rapidly (tmax of 1.0-1.5 h) and well absorbed (at least 84%). ADENURIC should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment. 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 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). To achieve sUA less than 6 mg/dL, the dose of febuxostat was titrated from 40 mg up to 80 mg (regardless of renal function) and the dose of allopurinol was titrated in 100 mg increments from 300 to 600 mg in patients with normal renal function and mild renal impairment and from 200 to 400 mg in patients with moderate renal impairment. Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. Do not take a double dose to make up for a forgotten dose. Febuxostat has an apparent mean terminal elimination half-life (t1/2) of approximately 5 to 8 hours. Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) were associated with fever, haematological, renal or hepatic involvement in some cases. ADENURIC should be taken by mouth and can be taken with or without food. Do not use this medicine after the expiry date which is stated on the carton and the tablet blister foil after ‘EXP.’ The expiry date refers to the last day of that month. This has not been observed in the pivotal clinical study with ADENURIC in the Tumor Lysis Syndrome. Seven hundred sixty (760) patients were randomized: ADENURIC 80 mg QD (n=256), ADENURIC 120 mg QD (n=251), or allopurinol 300 mg QD (n=253). Uncommon: Left bundle branch block, sinus tachycardia. FLORENCE was a randomized (1:1), double blind, phase III, pivotal trial comparing ADENURIC 120 mg once daily with allopurinol 200 to 600 mg daily (mean allopurinol daily dose [± standard deviation]: 349.7 ± 112.90 mg) in terms of control of serum uric acid level. Febuxostat is eliminated by both hepatic and renal pathways. Absolute bioavailability of the febuxostat tablet formulation has not been studied. In the randomized, double-blind, Phase 3 pivotal FLORENCE (FLO-01) study comparing febuxostat with allopurinol (346 patients undergoing chemotherapy for haematologic malignancies and at intermediate-to-high risk of TLS), only 22 (6.4%) patients overall experienced adverse reactions, namely 11 (6.4%) patients in each treatment group. 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. In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.87-1.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73). ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule shaped. ADENURIC 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. 1 results from subjects receiving either 100 mg QD (n=10: patients with serum creatinine >1.5 and ≤2.0 mg/dL) or 300 mg QD (n=509) were pooled for analyses. 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). Adenuric® est un médicament qui se présente sous la forme d’un comprimé pelliculé (de 80 ou de 120 mg). The efficacy and safety of ADENURIC in the prevention and treatment of Tumor Lysis Syndrome was evaluated in the FLORENCE (FLO-01) study. 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. The 120 mg film-coated tablets are marked on one side with ‘120’. A. Menarini Farmaceutica Internazionale SRL. Potent inducers of UGT enzymes might possibly lead to increased metabolism and decreased efficacy of febuxostat. Animal studies have shown excretion of this active substance in breast milk and an impaired development of suckling pups. U niektórych osób ilość kwasu moczowego we krwi zwiększa się i może stać się za duża, aby związek pozostawał rozpuszczony. Siga tomando ADENURIC todos los días, incluso si ya no tiene crisis de gota. When suggestions are available use up and down arrows to review and ENTER to select. In patients with very high urate levels (e.g. 6. but also serious life threatening allergic conditions with cardiac and circulatory arrest. Gout: The recommended oral dose of ADENURIC is 80 mg once daily without regard to food. La ranura en el comprimido de 80 mg sirve únicamente para partir el comprimido si le resulta difícil tragarlo entero. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 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%). Thus, co-administration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds. Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation. Not everyone gets flares, but you could get a flare-up even if you are taking ADENURIC, and especially during the first weeks or months of treatment. In most cases, these reactions occurred during the first month of therapy with febuxostat. This information is intended for use by health professionals. Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected. 91% and 93% of patients on initial treatment with febuxostat 80 mg and 120 mg, respectively, had sUA <6 mg/dL at Month 36). For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Primary endpoint in the sub group of patients with sUA ≥ 10 mg/dL. Identified risk factors among these patients were a medical history of atherosclerotic disease and/or myocardial infarction, or of congestive heart failure. In healthy subjects concomitant use of febuxostat and naproxen 250mg twice daily was associated with an increase in febuxostat exposure (Cmax 28%, AUC 41% and t1/2 26%). No statistically significant differences were found and no causal relationship with febuxostat was established. This medicine does not require any special storage conditions. Each tablet contains 114.75 mg of lactose (as monohydrate). Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that ADENURIC does not adversely affect performance. If a gout flare occurs during febuxostat treatment, it should not be discontinued. ADENURIC se comercializa en comprimidos de 80 mg y de 120 mg. El médico le prescribirá la dosis más adecuada. Serum urate levels were maintained over time (i.e. No significant difference in mean serum creatinine change (%) occurred between ADENURIC and allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 respectively; least square means difference: 4.0970 [95% confidence interval: -0.6467 ; 8.8406]; p=0.0903). Do not stop taking ADENURIC without the advice of your doctor even if you feel better. If you have or have had heart failure, heart problems or stroke, If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment of Gout), If you have or have had liver disease or liver function test abnormalities, If you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood), rash including severe forms (e.g. The product code(s) for this leaflet are: EU/1/08/447/021, EU/1/08/447/002, EU/1/08/447/008, EU/1/08/447/022, EU/1/08/447/024, EU/1/08/447/020, EU/1/08/447/003, EU/1/08/447/012, EU/1/08/447/023, EU/1/08/447/010, EU/1/08/447/009, EU/1/08/447/006, EU/1/08/447/007, EU/1/08/447/004, EU/1/08/447/001, EU/1/08/447/005, EU/1/08/447/011, EU/1/08/447/019. ADENURIC is verkrijgbaar als tablet van 80 mg of 120 mg. Uw arts schrijft u de sterkte voor die voor u het meest geschikt is. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Il est à prendre une fois par jour pendant ou hors des repas. *** See section 5.1 for incidences of gout flares in the individual Phase 3 randomized controlled studies. For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. 5 How to store ADENURIC The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day. It is not known if ADENURIC may pass into human breast milk. If you have any further questions, ask your doctor or pharmacist. When suggestions are available use up and down arrows to review and ENTER to select. In the analysis of the individual components of MACE, the rate of CV deaths was higher with febuxostat than allopurinol (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73). Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation. more than 96 % of patients did not require treatment for a flare) at Month 16-24 and at Month 30-36. Adenuric est utilisé pour le traitement de l’hyperuricémie (taux élevés d’acide urique ou d’«urate» dans le sang) de longue durée. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357μmol/L). Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects. Adenuric 120 mg Filmtabletten Adenuric 120mg Filmtabletten Febuxodor 120mg Filmtabletten Febuxostat - 1 A Pharma 120mg Filmtabletten Febuxostat AbZ 120 mg Filmtabletten Febuxostat Accord 120 mg Filmtabletten Menarini International Operations Luxembourg S.A. Eligible patients had to be candidates for allopurinol treatment or have no access to rasburicase. ADENURIC Hakkında Kısa Bilgi ADENURIC 80 MG 28 FILM KAPLI TABLET, MENARÄ°NÄ° Ä°LAÇ SANAYÄ° VE TÄ°CARET A.Ş. In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3). 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. Å to ADENURIC sadrži Djelatna tvar je febuksostat. ADENURIC Comp. For the full list of excipients, see section 6.1. Drug interaction studies of febuxostat with other cytotoxic chemotherapy have not been conducted. Azathioprine (used to reduce immune response). Between 46% and 55% of subjects received treatment for gout flares from Week 8 and Week 28. 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 you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine. Four pharmacologically active hydroxyl metabolites have been identified, of which three occur in plasma of humans. Usually treatment is short-term. In total, 6,190 patients were followed for a median of 32 months and the median duration of exposure was 728 days for patients in febuxostat group (n 3098) and 719 days in allopurinol group (n 3092). con película 120 mg Para acceder al módulo de interacciones o de información de dopaje del medicamento debe registrarte e ingresar con tu email y … Febuxostat was shown to be a weak inhibitor of CYP2C8 in vitro. With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.875 [95% confidence interval: 0.4408 ; 1.7369]; p=0.8488) nor of clinical TLS (1.7% and 1.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.994 [95% confidence interval: 0.9691 ; 1.0199]; p=1.0000). Like all medicines, this medicine can cause side effects, although not everybody gets them. ADENURIC works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The score line on the 80 mg tablet is only there to help you break the tablet if you have difficulty swallowing it whole. blisters, nodules, itchy-, exfoliative rash), itchiness. The FACT study showed the statistically significant superiority of both ADENURIC 80 mg and ADENURIC 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). In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA < 6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively. Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu. Reduction in serum uric acid level to <6.0 mg/dL (357 µmol/L) was noted by the Week 2 visit and was maintained throughout treatment. A. Menarini Farmaceutica Internazionale SRL. Plasma protein binding of the active metabolites ranges from about 82% to 91%. Therefore, possible interactions with any concomitantly administered cytotoxic drug cannot be ruled out. Gout flare prophylaxis is recommended (see section 4.2 and 4.4). Clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets. Your doctor may ask you to have blood tests to check that your liver is working normally. You may need to read it again. These adverse reactions were mostly mild or moderate in severity. Keep this leaflet. Prevention and treatment of hyperuricaemia in patients at risk of TLS. wenn Sie allergisch gegen Febuxostat oder einen der in Abschnitt 6. genannten sonstigen Bestandteile dieses Arzneimittels sind. 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. Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side. ADENURIC 120 mg is available in pack sizes of 14, 28, 42, 56, 84 and 98 film-coated tablets. Adenuric® 120 mg 28 St für nur € 48,84 bei Ihrer Online Apotheke für Deutschland kaufen. Si el ácido úrico en suero es >6 mg/dl (357 µmol/l) después de 2-4 semanas, puede considerarse la administración de ADENURIC 120 mg una vez al día. CARES Study was a multicenter, randomized, double-blind, non inferiority trial comparing CV outcomes with febuxostat versus allopurinol in patients with gout and a history of major CV disease including MI, hospitalization for unstable angina, coronary or cerebral revascularization procedure, stroke, hospitalized transient ischemic attack, peripheral vascular disease, or diabetes mellitus with evidence of microvascular or macrovascular disease. ADENURIC 120 mg tablets is also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers. Febuxostat is a potent, non-purine selective inhibitor of XO (NP-SIXO) with an in vitro inhibition Ki value less than one nanomolar. The mean serum uric acid levels over time for each treatment group from the two pivotal Phase 3 studies are shown in Figure 1. In vitro studies with human liver microsomes showed that those oxidative metabolites were formed primarily by CYP1A1, CYP1A2, CYP2C8 or CYP2C9 and febuxostat glucuronide was formed mainly by UGT 1A1, 1A8, and 1A9. 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. Thus, ADENURIC may be taken without regard to food. ADENURIC 120 mg tablets is also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers. Mean AUC sUA1-8 (mgxh/dl) was significantly lower with ADENURIC (514.0 ± 225.71 vs 708.0 ± 234.42; least square means difference: -196.794 [95% confidence interval: -238.600; -154.988]; p < .0001). Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1). Following multiple oral doses of ADENURIC, the Cmax and AUC were 24% and 12% higher in females than in males, respectively. Always take this medicine exactly as your doctor has told you. It may harm them, even if their signs of illness are the same as yours. You can also report side effects directly (see details below). Gewoonlijk is de behandeling van korte duur. Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. There is no appreciable accumulation when doses of 10 mg to 240 mg are administered every 24 hours. 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. Carcinogenesis, mutagenesis, impairment of fertility. Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica. The rate of all-cause mortality was also higher with febuxostat than allopurinol (7.8% vs. 6.4% of patients; HR 1.22; 95% CI 1.01-1.47), which was mainly driven by the higher rate of CV deaths in that group (see section 4.4). The effect of ADENURIC on human fertility is unknown. 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%). Medicinal product allergy / hypersensitivity. The text only version may be available in large print, Braille or audio CD. Following multiple oral 80 mg once daily doses or a single 120 mg dose with a high fat meal, there was a 49% and 38% decrease in Cmax and a 18% and 16% decrease in AUC, respectively. This leaflet was last revised in 07/2019. 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).

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