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. Each tablet contains 80 mg or 120 mg of febuxostat. In the FLORENCE study ADENURIC demonstrated a superior control of serum uric acid level compared to allopurinol in patients scheduled to receive the latter drug. The safety and the efficacy of ADENURIC in children aged below the age of 18 years have not been established. 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. 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). Each tablet contains 114.75 mg of lactose (as monohydrate). Flares increased following the prophylaxis period and gradually decreased over time. or search for MHRA Yellow Card in the Google Play or Apple App Store. In addition to the urinary excretion, approximately 45% of the dose was recovered in the faeces as the unchanged febuxostat (12%), the acyl glucuronide of the active substance (1%), its known oxidative metabolites and their conjugates (25%), and other unknown metabolites (7%). 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. Azathioprine (used to reduce immune response). Do not pass it on to others. Possible side effects ADENURIC should not be used during pregnancy. 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. These findings are considered a consequence of species specific purine metabolism and urine composition and of no relevance to clinical use. 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). If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, ADENURIC 120 mg once daily may be considered. 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). 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. Between 46% and 55% of subjects received treatment for gout flares from Week 8 and Week 28. Gout flare prophylaxis is recommended (see section 4.2 and 4.4). 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. Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy. This site uses cookies. 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. Febuxostat can be co-administered with colchicine or indomethacin with no dose adjustment of febuxostat or the co-administered active substance being necessary. In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3). Febuxostat is eliminated by both hepatic and renal pathways. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. In most cases, these reactions occurred during the first month of therapy with febuxostat. The rash may progress to widespread blistering or peeling of the skin. redness of the face or neck), increased blood pressure, bleeding (hemorrhage, seen only in patients taking chemotherapy for blood disorders), cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis, dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort, itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, other type of skin conditions, muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm, blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly, stones in the gallbladder or in bile ducts (cholelithiasis), increase in blood thyroid stimulating hormone (TSH) level, changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results), muscle damage, a condition which on rare occasions can be serious. You may need to read it again. What you need to know before you take ADENURIC Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica. E' commercializzato in Italia da A. Menarini Industrie Farmaceutiche Riunite S.r.l. Gout flares were commonly observed soon after the start of treatment and during the first months. Adenuric 120mg plÄvele dengtos tabletÄs N28 (PVC/PE/PVDC/alu). Los comprimidos se toman por vía oral, con o sin comida. 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. For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. Se poate administra cu sau fara alimente. Blister trasparente (Aclar/PVC/Alluminio o PVC/PE/PVDC/Alluminio) contenente 14 compresse. ADENURIC 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers. At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended (see section 4.2). 4. There is no appreciable accumulation when doses of 10 mg to 240 mg are administered every 24 hours. This medicinal product does not require any special storage conditions. The efficacy and safety of febuxostat has not been established in patients with acute severe TLS, e.g. ADENURIC 120 mg -tabletteja käytetään myös veren suuren virtsahappopitoisuuden hoitoon ja ehkäisyyn potilailla, joilla veren virtsahappopitoisuus saattaa suurentua kun solunsalpaajahoito aloitetaan verisyövän vuoksi. Adenuric 80mg plÄvele dengtos tabletÄs N28 (PVC/PE/PVDC/alu). It may cause muscle problems and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. Rates of adjudicated hospitalization for heart failure, hospital admissions for arrhythmias not associated with ischemia, venous thromboembolic events and hospitalization for transient ischemic attacks were comparable for febuxostat and allopurinol. ADENURIC se comercializa en comprimidos de 80 mg y de 120 mg. El médico le prescribirá la dosis más adecuada. Film-coating: Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide yellow (E172), What ADENURIC looks like and contents of the pack. ADENURIC is available as a 120 mg tablet. If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, ADENURIC 120 mg once daily may be considered. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition (see section 5.3). Patients with an overdose should be managed by symptomatic and supportive care. Medicinal product allergy / hypersensitivity. Co-administration of febuxostat 80 mg and theophylline 400mg single dose in healthy subjects showed absence of any pharmacokinetic interaction (see section 4.5). The efficacy of ADENURIC was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout. This information is intended for use by health professionals. Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity. 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. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Svaka tableta sadrži 80 mg ili 120 mg febuksostata. ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule shaped. ADENURIC se comercializa en comprimidos de 80 mg y de 120 mg. El médico le prescribirá la dosis más adecuada. 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). To view the changes to a medicine you must sign up and log in. Contents of the pack and other information. These measures will help protect the environment. 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). There was no significant increase in any other tumour type in either male or female mice or rats. Adenuric 120 mg 28 compresse rivestite è un medicinale soggetto a prescrizione medica (classe A), a base di febuxostat, appartenente al gruppo terapeutico Antigottosi. Il est à prendre une fois par jour pendant ou hors des repas. FOCUS Study (TMX-01-005) was a 5 years Phase 2, open-label, multicenter, safety extension study for patients who had completed the febuxostat 4 weeks of double blind dosing in study TMX-00-004. ADENURIC 120 mg : comprimé (jaune) ; boîte de 28 Sur ordonnance (Liste I) - Remboursable à 65 % - Prix : 15,89 ⬠. Usually treatment is short-term. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine. * p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg. 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). To view the changes to a medicine you must sign up and log in. 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. There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of ADENURIC, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk. Prophylaxis against gout flares was obligatory over the 26-week period. ADENURIC atua de forma suficientemente rápida para permitir a reavaliação do ácido úrico sérico após 2 semanas. in patients who failed on other urate lowering therapies. Figure 1 Mean Serum Uric Acid Levels in Combined Pivotal Phase 3 Studies. etkin maddesi barındıran bir ilaçtır. The primary endpoint in CARES was the time to first occurrence of MACE, a composite of non-fatal MI, non-fatal stroke, CV death and unstable angina with urgent coronary revascularization. Dans tous les cas, ce traitement ne doit pas être instauré avant la disparition complète dâune crise de goutte. Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience in gout patients, 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, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome), Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome), 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 increased, 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. Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience. Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn. Primary endpoint in the sub-group of patients with renal impairment. 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. Contents of the pack and other information, 1. It allows continued monitoring of the benefit/risk balance of the medicinal product. There were no significant changes observed in AUC of febuxostat or its metabolites following multiple oral doses of ADENURIC in elderly as compared to younger healthy subjects.
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