Febuxostat Tablets for Long Term Treatment of Hyperuricemia in Gout Patients.

• Transport Package: Box
• Specification: 40mg*14tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC36
• Production Capacity: 10000PCS/ Month

Product Description

Item Name:Febuxostat tablets

Item Description

Item nanme:Febuxostat tablets
Item character:This product is a white 

Indication:
It is suitable for the long-term treatment of hyperuricemia in patients with gout.
It is not recommended for hyperuricemia without clinical symptoms.

Item specifications:40mg*14tab/box

Usage and dosage:The recommended oral dose of fenbustam tablets was 40mg or 80 mg once a day.
The recommended starting dose of non bustam tablets is 40mg once a day. If the level of serum uric acid is not lower than 6mg/dl (about 360 μ mol/l) after 2 weeks, the recommended dose is increased to 80mg once a day.
The effects of food and acid inhibitors are not required when administration.
Special groups
Patients with liver dysfunction: Patients with mild or moderate liver dysfunction (child Pugh a, B grade) do not need to adjust the dose. The efficacy and safety of febuxostat in patients with severe liver dysfunction (child Pugh grade C) have not been studied, so it should be used with caution.
Renal insufficiency: Patients with mild or moderate renal insufficiency (clcr30-89 ml / min) do not need to adjust the dose. The recommended initial dose of febuxostat is 40mg once a day. If the serum uric acid level is not lower than 6mg / dl after 2 weeks, it is recommended to increase the dosage to 80mg once a day. There is no sufficient research data of patients with severe renal insufficiency (clcr < 30ml / min), so we should use febuxostat with caution.
Uric acid level
Two weeks after the start of febuxostat treatment, we can evaluate whether the serum uric acid level reaches the target value (less than 6mg / dl).
Gout attack
In the early stage of taking this product, it may cause gout attack, because the change of blood uric acid level leads to the mobilization of tissue deposited urate. In order to prevent the onset of gout in the initial stage of taking febuxostat, it is recommended to take NSAIDs or colchicine at the same time. The benefits of preventive treatment can be as long as six months.
During febuxostat treatment, if gout attacks, there is no need to discontinue medication. Gout should be treated according to the individual condition of patients

Adverse reactions
The following information is reported in foreign literature
1. Clinical trial experience
Because clinical trials are conducted under a wide range of conditions, the incidence of adverse reactions observed in clinical trials can not be directly compared with another drug in clinical trials, nor can it reflect the incidence of adverse reactions in clinical practice.
In the clinical study, 2757 gout patients with hyperuricemia received either 40mg or 80mg once a day of febuxostat. In the 40 mg group, 559 patients were treated for more than 6 months. In the 80 mg dose group, 1377 patients had a treatment period of ≥ 6 months, 674 patients had a treatment period of ≥ 1 year, and 515 patients had a treatment period of ≥ 2 years.
Common adverse reactions: the incidence of febuxostat group was at least 1%, which was higher than that of placebo group at least 0.5%.

*According to the condition of renal insufficiency, allopurinol was given in different doses, including 100mg in 10 cases, 200mg in 145 cases and 300mg in 1122 cases.

The most common adverse reactions leading to discontinuation of treatment were abnormal liver function. The discontinuation rates were 1.8% in the 40 mg group, 1.2% in the 80 mg group and 0.9% in the allopurinol group.

In addition to the adverse reactions in Table 1, although the incidence of dizziness in the febuxostat group was more than 1%, it was less than 0.5% higher than that in the placebo group.

Occasional adverse reactions

In phase II and phase III clinical studies, the following adverse reactions occurred in less than 1% of subjects in the dose range of 40-240 mg:

Blood and lymphatic system: anemia, idiopathic thrombocytopenic purpura, leukocytosis / reduction, neutropenia, pancytopenia, splenomegaly, thrombocytopenia.

Heart: angina pectoris, atrial fibrillation / atrial flutter, heart murmur, abnormal electrocardiogram, palpitation, sinus bradycardia, tachycardia.

Ear and labyrinth: deafness, tinnitus, vertigo.

Eye: blurred vision.

Gastrointestinal tract: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, frequent defecation, gastrointestinal discomfort, gastritis, gastroesophageal reflux disease, gingival pain, hemoptysis, excessive gastric acid, bloody stool, oral ulcer, pancreatitis, peptic ulcer, vomiting.

Systemic and administration site: weakness, chest pain / discomfort, edema, fatigue, paresthesia, abnormal gait, epidemic symptoms, mass, pain, thirst.

Hepatobiliary system: cholelithiasis / cholecystitis, hepatic steatosis, hepatitis, hepatomegaly.

Immune system: allergic reaction.

Infection: herpes zoster.

Complications: contusion.

Metabolism and nutrition: anorexia, decreased / increased appetite, dehydration, diabetes, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss / gain.

Musculoskeletal and connective tissue: arthritis, joint stiffness, joint swelling, muscle spasm / convulsion / tension / weakness, bone pain / stiffness, myalgia.

Nervous system: abnormal taste, abnormal balance, cerebrovascular accident, Guillain Barr é syndrome, headache, hemiplegia, hypoesthesia, hypoesthesia, lacunar cerebral infarction, lethargy, mental disorder, migraine, paresthesia, lethargy, transient ischemic attack, tremor.

Mental diseases: irritability, anxiety, depression, insomnia, irritability, hyposexuality, nervousness, acute anxiety, personality change.

Urinary system: hematuria, kidney stones, frequent urination, proteinuria, renal failure, renal insufficiency, urgency of urination, urinary incontinence.

Reproductive system and breast: breast pain, erectile dysfunction, gynecomastia.

Breathing, chest, mediastinum: bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive secretion of sinuses, pharyngeal edema, respiratory congestion, sneezing, throat inflammation, upper respiratory tract infection.

Skin and subcutaneous tissue: hair loss, vascular edema, dermatitis, skin scratch, ecchymosis, eczema, hair color change, abnormal hair growth, hyperhidrosis, peeling, ecchymosis, photoallergy, pruritus, purpura, skin discoloration / pigmentation, skin lesions, abnormal skin odor, urticaria.

Blood vessels: flushing, hot flashes, hypertension, hypotension.

Laboratory indexes: prolonged activated partial thromboplastin time, increased creatine, decreased bicarbonate, increased sodium, abnormal electroencephalogram, increased blood glucose, increased cholesterol, increased triglyceride, increased amylase, increased potassium, increased thyroid stimulating hormone, decreased platelet count, decreased hematocrit, decreased hemoglobin, increased mean corpuscular volume, and decreased erythrocyte count The results showed that the levels of serum creatinine, blood urea, blood urea nitrogen / creatinine ratio, creatine phosphokinase, alkaline phosphatase, lactate dehydrogenase, prostate-specific antigen, urine volume, lymphocyte count, neutrophil count, white blood cell, coagulation test, low density lipoprotein and prothrombin time were increased The results showed that there was no significant difference between the two groups.
Cardiovascular risk
In randomized controlled and long-term extended studies, cardiovascular events and death are one of the predetermined endpoints of APTC (anti platelettrialists' collaborations), including cardiovascular death, non fatal myocardial infarction and non fatal stroke. In a randomized controlled phase III trial, the incidence of APTC events per 100 patient years were: placebo group 0 (95% CI 0.00-6.16), febuxostat 40mg group 0 (95% CI 0.00-1.08), febuxostat 80mg group 1.09 (95% CI 0.44-2.24), allopurinol group 0.60 (95% CI 0.16-1.53).
In the long-term extended study, the incidence of APTC events was 0.97 (95% CI 0.57-1.56) in febuxostat 80 mg group and 0.58 (95% CI 0.02-3.24) in allopurinol group.
In conclusion, compared with allopurinol group, febuxostat treatment group has a higher incidence of APTC events, but the causal relationship with febuxostat has not been determined. The symptoms and signs of myocardial infarction and stroke should be monitored when taking medicine.
2. Post marketing experience of foreign products
In the use of post marketing febuxostat, the adverse reactions were identified. Since these adverse reactions are spontaneously reported from an unknown number of patients, it is impossible to accurately assess their frequency or determine their causal relationship with drugs.
Hepatobiliary abnormalities: liver failure (some fatal), jaundice, severe abnormal liver function test results, liver disease.
Abnormal immune system: allergic reaction.
Musculoskeletal and connective tissue abnormalities: rhabdomyolysis.
Mental disorder: psychotic behavior including aggressive tendency.
Renal and urinary system abnormalities: tubulointerstitial nephritis.
Skin and subcutaneous tissue abnormalities: systemic rashes, Stevens Johnson syndrome, skin allergic reactions.

Taboo:
This product is prohibited in patients undergoing thioazaprine and thiopurine treatment

Matters needing attention:
Gout attack
In the early stage of taking febuxostat, gout attack frequency often increases. This is due to the decrease of blood uric acid concentration, which leads to the mobilization of urate deposited in tissues. In order to prevent gout attack in the early stage of treatment, it is recommended to take NSAIDs or colchicine at the same time.
During febuxostat treatment, if gout attacks, there is no need to discontinue febuxostat treatment. Gout should be treated according to the specific situation of patients.
Cardiovascular event
In randomized controlled trials, compared with allopurinol, patients treated with febuxostat had a higher probability of cardiovascular thrombotic events (including cardiovascular death, non fatal myocardial infarction and non fatal stroke), with febuxostat 0.74/100 patient years (95% CI: 0.36-1.37) and allopurinol 0.60/100 patient years (95% CI: 0.16-1.53). The causal relationship between febuxostat and cardiovascular thrombotic events has not been established. The symptoms and signs of myocardial infarction and stroke should be monitored during medication.
Effects on liver
There have been post marketing reports of fatal and nonfatal liver failure in patients taking febuxostat, although the information in these reports to determine the causal relationship between them is not sufficient. In a randomized controlled study, transaminase was observed to increase to more than 3 times of the upper limit of normal range (ULN) (the incidence of AST: 2%, 2%; ALT: 3%, 2% in the non buxostat and allopurinol groups, respectively). There was no dose-response relationship between these elevated transaminases.
Patients should have a liver function test (serum alanine aminotransferase [ALT], aspartate aminotransferase [ast], alkaline phosphatase and total bilirubin) before the first use of febuxostat, and take this result as the baseline level.
The patients who reported fatigue, loss of appetite, right upper abdomen discomfort, soy sauce color urine or jaundice and other symptoms that may indicate liver damage should be timely tested for liver function. Clinically, if the patient is found to have abnormal liver function (ALT more than 3 times of the upper limit of the reference range), the drug should be stopped and investigated to determine the possible causes. Febuxostat should not be used again in patients with abnormal liver function and no other reasonable explanation.
If the patient's serum ALT is more than 3 times of the reference range, and the serum total bilirubin is more than 2 times of the reference range, and other causes are excluded, the patient is at risk of serious drug-induced liver damage at this time. These patients should not re-use febuxostat. For those patients with small elevation of serum ALT or bilirubin and other reasonable explanations, the use of febuxostat should be cautious.
Secondary hyperuricemia
There is no research on the application of this product in patients with secondary hyperuricemia (including organ transplant recipients), so it is not recommended to use this product in patients with high uric acid level (such as malignant diseases, Lesch Nyhan syndrome). A small number of cases showed that the urine xanthine concentration increased significantly and then deposited in the urinary tract.

Medication for pregnant and lactating women:
pregnant woman
FDA's pregnancy safety classification is category C: there are not enough control studies in pregnant women. Therefore, only when it is confirmed that the potential benefits outweigh the risks to the fetus can febuxostat be used during pregnancy.
After oral administration of 48 mg / kg febuxostat (equivalent to 40 and 51 times of human plasma exposure at 80 mg / D) to rats and rabbits, no teratogenicity was observed during organogenesis. However, in organogenesis and lactation period, when the oral dose of rats reaches 48 mg / kg (equivalent to 40 times of human plasma exposure at 80 mg / D), it can increase the mortality and reduce the weight gain of neonatal rats.
Lactating women
Studies on rats showed that febuxostat could be excreted through milk. But it is not known whether febuxostat will be excreted through human milk. As many drugs can be secreted into the milk, lactating women should use this product with caution.

Medication for children
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