Mode of application
Gout.
The recommended dose of febuxostat is 80 mg orally once daily, with or without food. If serum uric acid concentrations exceed 6 mg/dL (357 µmol/L) after 2–4 weeks of treatment, consider increasing the febuxostat dose to 120 mg once daily.
The duration of prevention of gout attacks is recommended for at least 6 months.
Tumor lysis syndrome (TTS).
The recommended dose of febuxostat is 120 mg orally once daily, with or without food.
Adenuric®
Uric acid is the end product of purine metabolism in the human body, formed as a result of a cascade of hypoxanthine-xanthine-uric acid reactions. Febuxostat is a 2-arylthiazole derivative and is a potent, selective, non-purine xanthine oxidase inhibitor (in vitro inhibition constant less than 1 nM). The enzyme xanthine oxidase catalyzes two stages of purine metabolism: the oxidation of hypoxanthine to xanthine, and then the oxidation of xanthine to uric acid.
As a result of selective inhibition of xanthine oxidase (oxidized and reduced forms) by febuxostat, the concentration of uric acid in the blood serum decreases.
At therapeutic concentrations, febuxostat does not inhibit other enzymes involved in purine or pyrimidine metabolism, such as guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase, or purine nucleoside phosphorylase.
Clinical efficacy and safety profile
Gout
The efficacy and safety of febuxostat was confirmed in three pivotal phase III clinical trials involving 4101 patients with hyperuricemia and gout (APEX, FACT and CONFIRMS).
In each of these studies, febuxostat was more effective in reducing and maintaining serum uric acid concentrations than allopurinol.
The primary endpoint in the APEX and FACT studies was the proportion of patients whose serum uric acid concentration did not exceed 6.0 mg/dL (357 μmol/L) over the past three months. In the CONFIRMS substudy, the primary endpoint was the proportion of patients whose serum uric acid concentration was less than 6.0 mg/dL at the last visit. These studies did not include patients who had undergone organ transplantation.
The APEX (febuxostat versus placebo and allopurinol) study included 1072 patients in the double-blind, randomized, multicenter, 28-week APEX trial.
Febuxostat was used at doses of 80 mg, 120 mg, or 240 mg once daily; allopurinol - at a dose of 300 mg once daily in patients with initial plasma creatinine ≤1.5 mg/dL and at a dose of 100 mg once daily in patients with initial plasma creatinine >1.5 mg/dL and ≤2.0 mg/dl.
The use of febuxostat at a dose of 240 mg (twice the recommended maximum) was studied to evaluate the safety profile of febuxostat.
When using febuxostat in doses of 80 mg and 120 mg once daily for 28 weeks, the proportion of patients whose serum uric acid concentration did not exceed 6.0 mg/dL (357 μmol/L) during the last three months was 48% and 65%, respectively, when using allopurinol - 22%.
The FACT (Febuxostat Versus Allopurinol Trial) trial enrolled 760 patients in the double-blind, randomized, multicenter, 52-week trial. Febuxostat was used at doses of 80 mg or 120 mg once daily, allopurinol was used at a dose of 300 mg once daily. When using febuxostat 80 mg and 120 mg once daily for 52 weeks, the proportion of patients whose serum uric acid concentration did not exceed 6.0 mg/dL (357 μmol/L) during the last three months was 53%. and 62%, respectively, and when using allopurinol - 21%.
The use of febuxostat led to a rapid decrease in plasma uric acid concentrations; this effect persisted for a long time. A decrease in serum uric acid concentrations of less than 6.0 mg/dL (357 µmol/L) was observed already in the second week of use (FACT study), and this concentration was maintained throughout the entire period of febuxostat use.
The randomized, controlled 26-week CONFIRMS trial (Studying the Safety and Efficacy of Febuxostat 40 mg and 80 mg once daily versus allopurinol 300 mg or 200 mg once daily in patients with gout and hyperuricemia) included 2269 patients. patients. At least 65% of patients in this study had mild to moderate renal impairment (creatinine clearance 30-89 ml/min).
When using febuxostat at a dose of 40 mg and 80 mg, the proportion of patients whose plasma uric acid concentrations were less than 6.0 mg/dL at the last visit was 45% and 67%, respectively, for allopurinol 300 mg/200 mg - 42 %.
Extended long-term open-label studies
The three-year, open-label, multicenter, randomized, safety extension study EXCEL with allopurinol included 1,086 patients (who completed the APEX or FACT study) who received febuxostat 80 mg once daily, febuxostat 120 mg once daily; or allopurinol 300 mg (for patients with baseline plasma creatinine ≤1.5 mg/dL) and 100 mg (for patients with baseline plasma creatinine >1.5 mg/dL and ≤2.0 mg/dL ) 1 time per day. Approximately 69% of patients did not require dose adjustment to establish a final stable dosage regimen.
The target serum uric acid level (less than 6.0 mg/dL) achieved with prior use of febuxostat did not change over time (in 91% and 93% of patients initially taking febuxostat at doses of 80 mg and 120 mg, respectively, serum uric acid concentration was less than 6.0 mg/dL at 36 months of use).
According to three-year follow-up, a decrease in the incidence of gout attacks was noted at 16-24 months and 30-36 months. Less than 4% of patients required treatment for acute gout attacks (i.e., more than 96% of patients did not require treatment for gout attacks). In 46% and 38% of patients continuously taking febuxostat, respectively, at a dose of 80 and 120 mg once daily, by the last visit, complete disappearance of the tophi palpated at the initial visit was noted.
The five-year, open-label, multicenter, Phase II safety extension study FOCUS included 116 patients who initially received febuxostat 80 mg once daily for 4 weeks. In 62% of patients, no dose adjustment was required to maintain a target serum uric acid concentration of less than 6.0 mg/dL, and 38% of patients required a dose adjustment to achieve the target level. At the last study visit, the proportion of patients whose serum uric acid concentration was less than 6.0 mg/dL (357 μmol/L) was more than 80% (81-100%) at each febuxostat dose studied.
Efficacy and safety profile in patients with renal impairment
In the APEX study, febuxostat was used in 40 patients with renal impairment (creatinine >1.5 mg/dL and ≤2.0 mg/dL). In patients with impaired renal function randomized to the allopurinol group, the dose of the latter was limited to 100 mg per day. In the febuxostat group, the primary endpoint was met in 44% of patients receiving febuxostat 80 mg once daily, 45% receiving 120 mg once daily, and 60% of patients receiving 240 mg once daily compared with 0% in the allopurinol group (100 mg once daily) and placebo group. There were no clinically significant differences in the degree of decrease in serum uric acid concentration compared to healthy volunteers (the decrease in uric acid concentration in the group of patients with normal renal function was 58%, in the group with severe renal failure - 55%).
A prospective analysis in the CONFIRMS study demonstrated that febuxostat was significantly more effective in reducing serum uric acid concentrations to less than 6 mg/dL compared with allopurinol 300 mg/200 mg in patients with gout and mild to moderate renal impairment (proportion of these patients in the study was 65%).
Primary endpoint in the subgroup of patients with serum uric acid concentrations greater than 10 mg/dL
Baseline serum uric acid concentrations greater than 10 mg/dL were observed in approximately 40% of patients included in the APEX and FACT studies. Among these patients, the primary endpoint (uric acid concentration less than 6 mg/dL in the last 3 visits) was achieved in 41% of patients taking febuxostat 80 mg once daily, in 48% of patients taking febuxostat 120 mg once daily. once daily, and in 66% of patients taking febuxostat 240 mg once daily, compared with 9% in the allopurinol 300 mg/100 mg group, and 0% in the placebo group.
According to the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (uric acid concentration of less than 6.0 mg/dL at the last visit) in the group of patients with a baseline serum uric acid concentration of more than 10 mg/dL receiving febuxostat 40 mg once a day day was 27%, 80 mg once daily - 49% and 300 mg or 200 mg allopurinol once daily -31%.
Proportion of patients requiring treatment for an acute attack of gout
APEX Study: During the 8-week prophylaxis period, a higher proportion of patients (36%) required treatment for an acute attack of gout in the febuxostat 120 mg/day group than in the febuxostat 80 mg group (28%). ), allopurinol at a dose of 300 mg (23%) and in the placebo group (20%). During the prophylactic period, the incidence of acute gout attacks increased, subsequently decreasing over time. Between 46% and 55% of patients were treated for an acute gout attack from weeks 8 to 28. Acute attacks of gout during the last four weeks of the study (weeks 24–28) occurred in 15% of patients in the febuxostat group (80 mg, 120 mg), in 14% of patients in the allopurinol group (300 mg), and in 20% of patients in the placebo.
FACT Study: During the 8-week prophylaxis period, a greater proportion of patients (36%) required treatment for an acute attack of gout in the febuxostat 120 mg daily group than in the febuxostat 80 mg daily group. (22%), allopurinol at a dose of 300 mg per day (21%). After the 8-week prophylaxis period, the incidence of gout flares increased and then gradually decreased over time (64% and 70% of patients were treated for gout flares from weeks 8 to 52). Acute attacks of gout during the last four weeks of the study (weeks 49-52) occurred in 6-8% of patients in the febuxostat group (80 mg, 120 mg), and in 11% of patients in the allopurinol group (300 mg).
The proportion of patients requiring treatment for an acute attack of gout (APEX and FACT studies) was numerically lower in groups where the mean uric acid concentration of serum less than 6.0 mg/dL, less than 5.0 mg/dL, or less than 0 mg/dL, compared with a group where the mean serum uric acid concentration was more than 6.0 mg/dL.
In the CONFIRMS study, the proportion of patients requiring treatment for an acute gout attack (day 1 to month 6) was 31% and 25% in the febuxostat 80 mg group and allopurinol 200/300 mg group, respectively. In the febuxostat 80 mg and febuxostat 40 mg groups, there was no difference between the proportions of patients requiring treatment for an acute attack of gout.
Tumor collapse syndrome
The efficacy and safety of febuxostat for the prevention and treatment of tumor collapse syndrome were studied in a randomized, double-blind, phase III study, FLORENCE. Febuxostat demonstrated a more potent and rapid reduction in serum uric acid concentrations compared to allopurinol, without a negative effect on renal function.
The study included 346 patients with hematologic malignancies who received cytostatic therapy and who had a moderate to high risk of developing tumor collapse syndrome. Patients received febuxostat 120 mg once daily or allopurinol 200-600 mg daily to evaluate the ability of febuxostat to maintain serum uric acid concentrations and to evaluate the effect of febuxostat on renal function. Patients who met the study inclusion criteria had to be candidates for treatment with allopurinol or not eligible for treatment with rasburicase.
The primary endpoints were: the area under the concentration-time curve was statistically significantly lower in the febuxostat group than in the allopurinol group.
The mean serum uric acid concentration 24 hours after initiation of febuxostat and at all subsequent measurements was significantly lower than in the allopurinol group.
There were no statistically significant differences in the effects of febuxostat and allopurinol on plasma creatinine levels.
The incidence of tumor collapse syndrome with the use of febuxostat and allopurinol was not statistically different according to either laboratory diagnostic criteria or clinical criteria.
The incidence of drug-related effects and adverse reactions was 67.6% versus 64.7%, and 6.4% versus 6.4% in the febuxostat group and the allopurinol group, respectively.
In the FLORENCE study, febuxostat demonstrated greater control of serum uric acid concentrations compared with allopurinol in patients scheduled to receive allopurinol. There are currently no data available to compare febuxostat with rasburicase.
The efficacy and safety of febuxostat in patients with severe acute tumor collapse syndrome (for example, in patients in whom other treatment regimens aimed at reducing uric acid concentrations have failed) have not been studied.
Features of application
Treatment of chronic hyperuricemia
Patients with previous serious cardiovascular disease (eg, myocardial infarction, stroke, or unstable angina) should not be treated with febuxostat unless there are no other appropriate treatment options.
Pregnant
Febuxostat should not be used during pregnancy.
Children
The safety and effectiveness of febuxostat in children (under 18 years of age) have not been established. No application data available.
Drivers
Patients taking febuxostat are advised to exercise caution when driving or operating machinery until they are confident that the above-mentioned adverse reactions are absent.
Adenuric, 28 pcs., 120 mg, film-coated tablets
Acute attack of gout
The use of Adenuric® should be started only after an acute attack of gout has subsided. Starting to use the drug Adenuric® can provoke the development of an acute attack of gout due to the release of urates from tissue depots and a subsequent increase in the concentration of uric acid in the blood serum.
To prevent gout attacks, in the absence of contraindications, simultaneous use of NSAIDs or colchicine for at least 6 months is recommended.
If an attack develops while using the drug Adenuric®, the use of the drug should be continued and, at the same time, appropriate treatment of an acute attack of gout should be carried out. With long-term use of the drug Adenuric®, the frequency and severity of gout attacks decrease.
Xanthine deposition
In rare cases, in patients with accelerated urate formation (for example, against the background of malignant neoplasms or Lesch-Nyhan syndrome), a significant increase in the absolute concentration of xanthines in the urine may occur, which may be accompanied by their deposition in the urinary tract. This phenomenon was not observed when febuxostat was used in the FLORENCE study in patients with tumor collapse syndrome. Due to limited data, the use of Adenuric® in patients with Lesch-Nyhan syndrome is not recommended.
Mercaptopurine/azathioprine
Concomitant use with mercaptopurine and azathioprine is not recommended. If simultaneous use is necessary, to reduce the toxic effect on the hematopoietic system, it is recommended to reduce the dose of mercaptopurine/azathioprine and careful medical supervision.
Theophylline
With simultaneous use of febuxostat in healthy volunteers at a dose of 80 mg 1 time per day and a single dose of theophylline 400 mg, no changes in pharmacokinetic parameters were observed. Thus, simultaneous use of febuxostat at a dose of 80 mg and theophylline does not carry the risk of increasing the concentration of theophylline in the blood plasma. Concomitant use of febuxostat 120 mg and theophylline has not been studied.
Patients who have undergone organ transplantation
The use of Adenuric® in patients who have undergone organ transplantation is not recommended due to the lack of experience with its use.
Allergic and hypersensitivity reactions
During post-marketing use, there have been rare reports of severe allergic reactions (hypersensitivity reactions), including Stevens-Johnson syndrome, toxicodermal necrolysis, anaphylactic reactions and shock.
In most cases, these reactions developed during the first month of using Adenuric®. Some patients had a history of renal failure and/or hypersensitivity reactions during the use of allopurinol.
In isolated cases, severe hypersensitivity reactions, including drug reaction syndrome with eosinophilia and systemic symptoms (DRESS), were accompanied by fever, changes in blood counts, and impaired liver or kidney function.
Patients should be informed of the possible signs and symptoms of allergic reactions (hypersensitivity reactions), and should be closely monitored for the development of symptoms of allergic reactions/hypersensitivity reactions.
In the event of severe allergic/hypersensitivity reactions, including Stevens-Johnson syndrome, it is necessary to immediately stop using Adenuric® (earlier discontinuation is associated with a better prognosis). Repeated use of the drug is not recommended.
Cardiovascular diseases
The use of Adenuric® is not recommended in patients with coronary heart disease or congestive heart failure.
In the APEX and FACT trials (as opposed to the CONFIRMS trial), the overall febuxostat group compared with the allopurinol group had an increase in the number of cardiovascular events defined according to the Antiplatelet Therapy Collaborative Review Group (CAATG) system, which included including death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke) - 1.3 compared to 0.3 cases per 100 patient-years. Pooled data from phase III clinical trials (APEX, FACT and CONFIRMS studies) showed an incidence of 0.7 cardiovascular events compared with 0.6 per 100 patient-years.
In long-term large-scale studies, the incidence of cardiovascular events in HSAAT was 1.2 and 0.6 cases per 100 patient-years for febuxostat and allopurinol, respectively. The differences were not statistically significant, and a cause-and-effect relationship between these disorders and the use of febuxostat was not established. A history of the following conditions was identified as risk factors for the development of these events in patients: atherosclerosis and/or myocardial infarction, or congestive heart failure.
Prevention and treatment of hyperuricemia in patients at risk of developing tumor collapse syndrome
In patients receiving cytostatic therapy for hemoblastoses with a risk of developing moderate to severe tumor collapse syndrome, the use of Adenuric®, if indicated, should be carried out under the supervision of a cardiologist. Liver diseases
According to pooled data from phase III clinical trials, mild liver dysfunction was observed in 5% of patients using febuxostat.
Before prescribing Adenuric®, it is recommended to evaluate liver function, and, if indicated, also during use.
Thyroid diseases
In extended long-term open studies with long-term use of febuxostat, 5.5% of patients experienced an increase in the concentration of thyroid-stimulating hormone (>5.5 μIU/ml), and therefore Adenuric® should be prescribed with caution to patients with impaired thyroid function.
The drug Adenurik® contains lactose, therefore its use in patients with lactase deficiency, hereditary lactose intolerance, and glucose-galactose malabsorption syndrome is contraindicated.
Impact on the ability to drive vehicles. Wed and fur.:
When taking the drug Adenurik®, drowsiness, dizziness, paresthesia and blurred vision may occur and, as a result, a decrease in reaction and ability to concentrate, therefore, while using the drug Adenurik®, care must be taken when driving vehicles and engaging in other potentially hazardous activities, requiring concentration and speed of psychomotor reactions.
Note!
Description of the drug Febuxostat Xantis table. p/o 80 mg No. 28 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
Adenuric 80 mg 28 pcs ➤ instructions for use
Taking into account the different nature of the course of gout and tumor decay syndrome, the side effects of febuxostat for these nosologies of action are presented separately. Gout
The most common side effects in patients with gout when using febuxostat according to the results of clinical studies (4072 patients taking febuxostat at a dose of 10 mg to 300 mg) and according to post-marketing surveillance data were: gout attack, liver dysfunction, diarrhea, headache, nausea , skin rash and swelling. In most cases, these phenomena were characterized by mild or moderate severity. During post-marketing surveillance, rare cases of hypersensitivity reactions to febuxostat, accompanied in some cases by systemic symptoms, have been reported. Possible side effects are listed below according to the World Health Organization classification in descending frequency of occurrence: very common (>1/10); often (>1/100,<1/10), uncommon (>1/1000,<1/100), rare (>1/10000,<1/1000), very rare (<1/10000), including some messages. The incidence of side effects is based on data from clinical studies and post-marketing experience in patients with gout. From the blood and lymphatic system Rarely: pancytopenia, thrombocytopenia. From the immune system Rarely: anaphylactic reactions*, hypersensitivity reactions*. From the nervous system: often: headache; Uncommon: dizziness, paresthesia, hemiparesis, drowsiness, changes in taste perception, hyposthesia, hyposmia (decreased sense of smell). From the endocrine system: Uncommon: increased concentration of thyroid-stimulating hormone (TSH) in the blood plasma. Metabolic and nutritional disorders Often: attacks of gout***; Uncommon: diabetes mellitus, hyperlipidemia, loss of appetite, weight gain; Rarely: weight loss, increased appetite, anorexia. Mental disorders: Uncommon: decreased libido, insomnia; Rarely: nervousness. From the side of the organ of vision Rarely: blurred vision. Hearing and labyrinthine disorders Rare: tinnitus. Cardiac disorders Uncommon: atrial fibrillation, palpitations, ECG changes, left bundle branch block (see section “Tumor Collapse Syndrome”), sinus tachycardia (see section “Tumor Collapse Syndrome”). Vascular disorders Uncommon: increased blood pressure, flushing of the face, feeling of heat, hemorrhage (see section “Tumor decay syndrome”). From the respiratory system, chest and mediastinal organs: Uncommon: dyspnea, bronchitis, upper respiratory tract infections, cough. From the digestive tract Often: diarrhea**, nausea; Uncommon: abdominal pain, bloating, gastroesophageal reflux disease, vomiting, dry oral mucosa, dyspeptic symptoms, constipation, frequent stools, flatulence, abdominal discomfort; Rarely: pancreatitis, ulcerative stomatitis. From the liver and biliary tract Often: liver dysfunction**; Uncommon: cholelithiasis; Rarely: hepatitis, jaundice*, liver damage*. From the skin and subcutaneous tissues Common: rash (including the various types of rash mentioned below with a lower frequency); Uncommon: dermatitis, urticaria, pruritus, skin discoloration, skin lesions, petechiae, macular rash, maculopapular rash, papular rash; Rare: toxic epidermal necrolysis*, Stevens-Johnson syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms* (see section "Special Instructions"), severe forms of generalized rash*, erythema, exfoliative rash, follicular rash, vesicular rash, pustular rash, pruritic rash*, erythematous rash, morbilliform rash, alopecia, hyperhidrosis. From the musculoskeletal system: Uncommon: arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tension, bursitis; Rare: rhabdomyolysis*, joint stiffness, muscle stiffness. Renal and urinary tract disorders Uncommon: renal failure, nephrolithiasis, hematuria, pollakiuria, proteinuria; Rarely: tubulointerstitial nephritis*, urinary urgency. Genital and breast disorders Uncommon: erectile dysfunction. General disorders and disorders at the injection site: Common: swelling; Uncommon: increased fatigue, chest pain, discomfort in the chest area; Rarely: thirst. Impact on the results of laboratory and instrumental studies Uncommon: increased amylase activity in the blood plasma, decreased platelet count, decreased leukocyte count, decreased lymphocyte count, increased creatine and creatinine levels in the blood plasma, decreased hemoglobin, increased urea concentration in the blood plasma, increased triglyceride concentration in the blood plasma, increased concentration of cholesterol in the blood plasma, decreased hematocrit, increased activity of lactate dehydrogenase in the blood plasma, increased potassium content in the blood plasma. Rarely: increased plasma glucose concentration, prolonged activated partial thromboplastin time, decreased red blood cell count, increased plasma alkaline phosphatase activity, increased plasma creatine phosphokinase concentration*. * Side effects observed during post-marketing surveillance. **Noninfectious diarrhea and liver disorders observed in phase III studies were more common during concomitant use of colchicine. ***Additional information regarding the development of acute attacks of gout in the section “Clinical efficacy and safety profile”. Description of selected side effects During post-marketing use, there have been rare reports of severe allergic reactions (hypersensitivity reactions), including Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic reactions and shock. Stevens-Johnson syndrome and toxic epidermal necrolysis are characterized by a progressive skin rash accompanied by bullous lesions of the skin or mucous membranes, as well as eye irritation. Hypersensitivity reactions to febuxostat may also include the following symptoms: skin reactions characterized by infiltrative maculopapular rashes; generalized or exfoliative rash, as well as skin lesions, facial swelling, fever, hematopoietic disorders such as thrombocytopenia and eosinophilia, and involvement of one or more organs (liver and kidneys, including tubulointerstitial nephritis). Attacks of gout usually occur soon after starting the use of Adenuric® and during the first months of therapy. Subsequently, the frequency of attacks decreases. It is recommended to prevent the development of acute attacks of gout. Tumor breakdown syndrome In the FLORENCE study comparing the effects of febuxostat and allopurinol (346 patients receiving chemotherapy for hematological malignancies and at moderate to high risk of developing tumor breakdown syndrome), side effects were noted in only 22 patients (6.4%). In both groups (febuxostat group and allopurinol group), the incidence of side effects was the same (11 patients each, 6.4%). In most cases, adverse events were mild or moderate in severity. Overall, with the exception of the three adverse events listed below from the FLORENCE study, no significant safety profile was observed for febuxostat beyond that for gout. Cardiac disorders Uncommon: left bundle branch block, sinus tachycardia. Vascular disorders: Uncommon: hemorrhages.
Adenuric tablets p/o 80 mg package No. 28
ADENURIK4 80 mg film-coated tablets Febuxostat Composition The active ingredient of the drug is febuxostat. One tablet contains 80 mg or 120 mg of febuxostat. Other components Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium salt, hydrated colloidal silicon dioxide. Tablet shell: Opadry II yellow, 85F42129: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172)
ADENURIC tablets are used to treat gout, a disease associated with excessive accumulation of uric acid (urate) in the body. Some people have too much uric acid in their blood, causing it to become insoluble. As a result, urate crystals can form and deposit in the joints and kidneys. This process may be accompanied by sudden severe pain, redness, swelling and increased temperature of the joint (a gout attack). If left untreated, individual crystals form large clusters (tophi) around the joints. In the future, tophi can destroy the joint and nearby bone. The effect of the drug ADENURIK is based on reducing the level of uric acid. While taking ADENURIK, the concentration of uric acid remains quite low, which prevents the formation of crystals and, over time, helps to reduce the severity of the symptoms of the disease. If the concentration of uric acid remains low for a long time, the size of the tophi usually decreases.
Contraindications Adenuric should not be taken: if you are allergic (hypersensitivity) to the active substance of Adenuric, febuxostat, or to other components of the drug. ADENURIC should be taken with caution Before starting treatment, be sure to tell your doctor if: You suffer (or have suffered) from heart failure or other heart diseases. You have been treated for high uric acid levels due to cancer or Lesch-Nyhan syndrome (a rare inherited disorder characterized by high levels of uric acid in the blood). You suffer from thyroid disease. If you are currently experiencing a gout flare-up (sudden severe pain, redness, tenderness, swelling and increased joint temperature), you should wait until it subsides before starting treatment with ADENURIC. In some cases, an exacerbation of gout may occur when treatment with uric acid-lowering drugs is started. This exacerbation does not occur in all patients, but in the first weeks or months of treatment with ADENURIC you may experience gout attacks. It is important not to stop treatment when such attacks occur, since even in this case ADENURIC helps to reduce the concentration of uric acid. If you take ADENURIC daily as prescribed by your doctor, over time your gout attacks will become less frequent and less painful. If necessary, your doctor may prescribe medications to prevent or relieve the symptoms of gout (pain and swelling of the joints). You may also have a blood test to evaluate your liver function.
Taking other medicines If you are taking or have recently taken any other medicines, including over-the-counter medicines, you should tell your doctor or pharmacist. It is especially important to report products containing the following substances that may interact with ADENURIC. In this case, the doctor may change the treatment regimen. Mercaptopurine (used to treat malignancies). Azathioprine (used to suppress the immune system). Theophylline (used to treat asthma). Combination of ADENURIK with food and drinks ADENURIK is taken orally before, during or after meals.
Pregnancy and breast-feeding The risk of adverse effects on the fetus during treatment with ADENURIC has not been established. Be sure to tell your doctor about your current or planned pregnancy, as in this case, taking ADENURIK is prohibited. It is also not known whether ADENURIC passes into breast milk. In this regard, it should not be taken during breastfeeding or in preparation for it.
Effect on the ability to drive vehicles and maintain machinery. Studies of the effect of ADENURIK on the ability to drive vehicles have not been conducted. However, it should be remembered that during treatment, dizziness, drowsiness, a feeling of numbness or tingling may occur, in the event of which it is recommended to refrain from driving vehicles or operating machinery.
Important information about some of the ingredients in ADENURIC ADENURIC tablets contain lactose (a certain type of sugar). If you have a known intolerance to any types of sugar, consult your doctor before using this drug.
How to take ADENURIC Always take ADENURIC as directed by your healthcare professional. If you have any additional questions, consult your doctor or pharmacist. ADENURIC is available in tablets of 80 mg and 120 mg. The attending physician will prescribe the drug in a dose that is most suitable for you. The standard dose of the drug is 1 tablet once a day. The days of the week are marked on the back of the blister pack so that you can control the regularity of taking the drug. ADENURIC is taken orally before, during or after meals. Do not stop taking ADENURIC without first consulting your doctor. It is important to take ADENURIC daily, even in the absence of gout attacks.
If you have exceeded the recommended dose of ADENURIC If you accidentally take a large dose of the drug, you should immediately inform your doctor or go to the nearest emergency room.
If you forget to take ADENURIC If you forget to take ADENURIC on time, take the next dose as soon as you remember. If you remember this shortly before your next dose, skip the forgotten dose and take the next one at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking ADENURIC Do not stop taking ADENURIC without first talking to your doctor, even if you feel significantly better. Discontinuation of treatment may be accompanied by an increase in uric acid concentrations and worsening of disease symptoms due to the formation of new urate crystals in the joints and kidneys. If you have questions about your treatment, ask your doctor or pharmacist.
Possible side effects Like all medicines, ADENURIC can cause side effects, although not all patients get them. Common side effects (affected in more than 1 in 100 patients, but in less than 1 in 10 patients): abnormal liver function tests diarrhea headache rash nausea increased gout symptoms Uncommon side effects (affected in more than 1 in 1000 patients, but in less than 1 in 100 patients: decreased appetite, changes in blood sugar levels (diabetes mellitus), which can be manifested by extreme thirst, increased levels of fats in the blood, loss of sex drive, sleep disturbances, dizziness, numbness or tingling, changes in taste perception, decreased or altered sensitivity to touch (hypoesthesia, paresthesia) changes in the electrocardiogram, extrasystoles, palpitations hot flashes (redness of the face or neck), increased blood pressure cough, shortness of breath, discomfort or pain in the chest, inflammation of the nose and/or throat (upper respiratory tract infection ), bronchitis dry mouth, abdominal pain/discomfort or flatulence, heartburn/indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort itching, hives, inflammation or change in skin color, other skin disorders muscle cramps, pain in muscles or joints, bursitis or arthritis (inflammation of the joints accompanied by pain, swelling and/or stiffness), pain in the limbs, back, muscle spasms, blood in the urine, frequent urination, changes in urinalysis (increased protein levels), impaired kidney function ; increased fatigue, local swelling due to fluid retention in the tissues, chest pain stones in the gall bladder or bile ducts (cholelithiasis) changes in clinical or biochemical blood tests kidney stones Rare side effects (affected in more than 1 in 10,000 patients , but in less than 1 in 1000 patients: allergic reactions (eg skin rash, itching, swelling) generalized skin rash If you experience the above side effects, you should contact your doctor immediately as there is a risk of serious allergic reactions nervousness thirst erection problems tinnitus hair loss oral ulcers inflammation of the pancreas: common symptoms include abdominal pain, nausea and vomiting increased sweating changes in body weight (increase/loss), increased appetite, uncontrollable loss of appetite (anorexia) muscle stiffness and /or joints abnormal blood cell count results on smear (white or red blood cells) an irresistible urge to urinate If any of the side effects listed above become serious, or if you notice a side effect, including those not listed in this leaflet, please , tell your doctor or pharmacist.
How to store ADENURIK Keep out of the reach of children. Do not use the drug after the expiration date indicated on the carton and blister after the words Best before. The expiration date refers to the last day of the indicated month. This medical product does not require special storage conditions. The drug should not be disposed of in the sewer or with household waste. Ask your pharmacist how to dispose of a drug that is no longer needed. Such measures serve to protect the environment.
Appearance of the drug ADENURIC and contents of the package ADENURIC 80 mg film-coated tablets: capsule-shaped film-coated tablets, pale yellow to yellow in color with 80 embossed on one side. ADENURIC 120 mg tablets are embossed with 120 on one side.
ADENURIC is available in packages of: 28 film-coated tablets (2 transparent (Aclar/PVC/aluminium) blisters for 14 film-coated tablets) along with an insert; 56 film-coated tablets (4 transparent (Aclar/PVC/aluminum) blisters for 14 film-coated tablets) along with an insert; 84 film-coated tablets (6 transparent (Aclar/PVC/aluminum) blisters for 14 film-coated tablets) together with an insert; Not all package sizes may be available.
Vacation schedule By doctor's prescription
Marketing Authorization Holder and Manufacturer Marketing Authorization Holder: Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare 1611 Luxembourg
Manufacturer: Patheon France Boulevard de Champaré, 40 38300 Bourgoin Jallieu France or Menarini - Von Heyden GmbH Leipziger Strasse 7-13 01097 Dresden Germany Authorized representative: BERLIN-CHEMIE AG (MENARINI GROUP) Glieniker Weg 125 12489 Berlin Germany
