Description
Latin name
Adenuric
Release form
Film-coated tablets.
Pharmacological action of
The antigout is a xanthine oxidase inhibitor.
Indications
Chronic hyperuricemia in conditions accompanied by the deposition of urate crystals (in the presence of tofus and / or gouty arthritis, including a history).
Treatment and prevention of hyperuricemia in adult patients during cytostatic therapy of hemoblastoses with a risk of moderate to high tumor decay syndrome (only for a dosage of 120 mg).
Adenuric ® is intended for use in adults.
Contraindications
– Hypersensitivity to febuxostat and / or any of the excipients
– children under 18
– pregnancy and the period of breast feeding
– hereditary galactose intolerance, lactase deficiency and malabsorption syndrome, glucose and galactose.
Precautions:
– Severe renal failure (creatinine clearance < 30 ml / min) (efficacy and safety have not been adequately studied) – liver failure – history of allergic reactions – coronary heart disease – congestive heart failure – thyroid disease – concomitant use with mercaptopurine / increase in concentration of data of azathioprine (possible substances in the blood plasma and increased toxicity) – conditions after organ transplantation (experience with febuxostat is limited) – Lesch-Nihan syndrome (experience with febuxostat ogre Nothing). Pregnancy and lactation Due to insufficient data, the potential risk of febuxostat to humans is not known, therefore the use of febuxostat during pregnancy is contraindicated. There is limited experience with the use of febuxostat during pregnancy, during which there were no adverse effects on the course of pregnancy and the condition of the fetus / newborn. In animal studies, there was no direct or indirect adverse effect of the drug on pregnancy, the development of the embryo / fetus, and the birth process. There is no data on whether febuxostat passes into breast milk. In animal studies, febuxostat passes into breast milk and has an adverse effect on the development of fed babies. Thus, risk to infants cannot be ruled out. In this regard, the use of febuxostat is contraindicated in the period of breastfeeding. Special instructions Acute seizure of gout Use of the drug Adenurik ® should only begin after relief of an acute seizure of gout. 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 blood serum. For the prevention of gout attacks in the absence of contraindications, the simultaneous use of NSAIDs or colchicine for at least 6 months is recommended. When an attack develops with the use of the drug Adenuric ®, the use of the drug should be continued and at the same time appropriate treatment for an acute attack of gout. With prolonged use of the drug Adenurik ®, the frequency and severity of gout attacks decrease. Xanthine deposition In rare cases, in patients with accelerated formation of urates (for example, against the background of malignant neoplasms or with Lesh-Nihan syndrome), a significant increase in the absolute concentration of xanthines in the urine is possible, which may be accompanied by their deposition in the urinary tract. When using febuxostat in the FLORENCE study in patients with tumor decay syndrome, this phenomenon was not observed. Due to limited data, the use of the drug Adenurik ® in patients with Lesch-Nihan syndrome is not recommended. Mercaptopurin / azathioprine Concomitant use with mercaptopurine, azathioprine is not recommended. If necessary, simultaneous use, 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 the simultaneous use of febuxostat in a dose of 80 mg once a day in healthy volunteers and a single dose of theophylline 400 mg, there were no changes in pharmacokinetic parameters. Thus, the simultaneous use of febuxostat in a dose of 80 mg and theophylline does not bear the risk of increasing theophylline concentration in blood plasma. A study of the simultaneous use of febuxostat at a dose of 120 mg and theophylline was not conducted. Patients who underwent organ transplantation The use of Adenurik ® in patients who underwent organ transplantation is not recommended due to the lack of experience in use. Allergic and hypersensitivity reactions In the post-marketing period, 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 Adenurik ®. Some patients had a history of renal failure and / or hypersensitivity reactions during the use of allopurinol. In some 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 case of severe allergic / hypersensitivity reactions, including Stevens-Johnson syndrome, the use of Adenuric ® should be stopped immediately (earlier withdrawal is associated with a better prognosis). Repeated use of the drug is not recommended. Cardiovascular disease Adenuric ® is not recommended for patients with coronary heart disease or congestive heart failure. In the APEX and FACT studies (as opposed to the CONFIRMS study), the total febuxostat group compared with the allopurinol group showed an increase in the number of disorders of the cardiovascular system, determined in accordance with the system developed by the group for the joint analysis of antiplatelet therapy (GSAAT) and including death from cardiovascular causes, non-lethal myocardial infarction, non-fatal stroke) – 1.3 compared with 0.3 cases per 100 patient-years. According to the combined data from phase III clinical trials (APEX, FACT, and CONFIRMS studies), the incidence of cardiovascular disorders was 0.7 compared with a frequency of 0.6 cases per 100 patient-years. In the framework of long-term large-scale studies, the frequency of cardiovascular disorders of GAAAT was 1, 2 and 0.6 cases per 100 patient-years for febuxostat and allopurinol, respectively. The differences were not statistically significant, a causal relationship between these disorders and taking febuxostat has not been established. As a risk factor for the development of these events in patients, a history of the following conditions was found: atherosclerosis and / or myocardial infarction, or congestive heart failure. Prevention and treatment of hyperuricemia in patients at risk of developing tumor decay syndrome In patients receiving cytostatic therapy of hemoblastoses with a risk of developing moderate to severe tumor decay syndrome, the use of Adenurik ® if indicated should be carried out under the supervision of a cardiologist. Liver diseases According to the combined data of phase III clinical trials using febuxostat in 5% of patients, mild liver function disorders were noted. Before prescribing Adenuric ®, it is recommended to evaluate liver function, and if indicated, also during use. Thyroid diseases In an extended, long-term open-label study with long-term use of febuxostat, 5.5% of patients showed an increase in thyroid-stimulating hormone concentration (> 5.5 ÑIU / ml), which is why Adenuric ® should be used in patients with thyroid dysfunction appoint with caution.
Adenuric ® contains lactose, therefore its use in patients with lactase deficiency, hereditary lactose intolerance, glucose-galactose malabsorption syndrome is contraindicated.
Impact on the ability to drive transp. Wed and fur .:
When taking Adenurik ®, drowsiness, dizziness, paresthesia, and blurred vision may occur and, as a result, decreased reaction and ability to concentrate, therefore, caution should be exercised when using Adenurik ® when driving vehicles or doing other things potentially dangerous activities that require concentration and speed of psychomotor reactions.
Dosage and Administration
Inside. The drug Adenurik® is taken once a day, regardless of food intake.
Gout
The recommended starting dose is 80 mg of febuxostat once a day.
After 2-4 weeks, it is recommended to control the concentration of uric acid in the blood serum. If the indicator exceeds 6 mg / dl (357 ?mol / L), the dose of the drug can be increased to 120 mg once a day.
The decrease in the concentration of uric acid in the blood serum during the use of the drug Adenurik® occurs quite quickly, and therefore the control of the concentration of uric acid can be carried out two weeks after the start of the drug. The aim of the treatment is to reduce and maintain a serum uric acid concentration of less than 6 mg / dl (357 ?mol / L).
Prevention of the development of acute attacks of gout is recommended for at least 6 months.
Tumor decay syndrome
The recommended dose is 120 mg of febuxostat once a day, regardless of food intake. Adenuric® should be taken two days before the start of cytostatic therapy. The duration of use of the drug Adenuric® should be at least 7 days. Depending on the duration of the chemotherapy course, the duration of the use of Adenuric® can be increased to 9 days.
Elderly patients
Dosage adjustment of the drug is not required.
Patients with hepatic insufficiency
Gout
In patients with mild hepatic insufficiency (class A on the Child-Pugh scale: 5-6 points), the recommended dose of the drug is 80 mg once a day. The experience of using the drug with moderate liver failure is limited.
Tumor decay syndrome
In the FLORENCE study, dose adjustment of febuxostat depending on liver function was not required (the study did not include patients with severe liver failure).
Studies on the efficacy and safety of using febuxostat in patients with severe hepatic insufficiency (class C on the Child-Pugh scale: 10-15 points) have not been conducted.
Patients with renal failure
Dose adjustment is not required in patients with mild or moderate renal failure.
In patients with severe renal failure (creatinine clearance <30 ml / min), the efficacy and safety of the drug have not been adequately studied. Overdose of In case of an overdose of the drug, symptomatic and supportive therapy is indicated. Symptoms: increased side effects. Shelf life 3 years. Do not use after the expiration date printed on the package. Prescription conditions from pharmacies Prescription Appointment Adult doctor
