Uxoric Special Precautions

Acute gout: An increased frequency of acute gout attacks (gout flare) may occur after initiation of febuxostat due to increased mobilization of urate from tissue deposits in response to reduction in serum uric acid concentrations, resulted in an increased frequency of acute gout attacks after initiation of febuxostat. For gout flare prophylaxis, NSAIDs or colchicine should be considered; these agents may be started when febuxostat therapy is initiated for up to 6 months. If a gout flare occurs during febuxostat administration, febuxostat may be continued, and the gout flare managed as appropriate.
Cardiovascular events: Treatment of febuxostat in patients with ischaemic heart disease or congestive heart failure is not recommended. Due to studies, a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, nonfatal myocardial infarction, nonfatal stroke) was reported in patients receiving febuxostat than in patients receiving allopurinol. Patients receiving febuxostat should be monitored for signs and symptoms of myocardial infarction and stroke.
However, the study of long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout found that febuxostat is non-inferior to allopurinol therapy with respect to the primary cardiovascular endpoint which was a composite of hospitalization for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death and its long-term use is not associated with an increased risk of death or serious adverse events compared with allopurinol.
Treatment in patients receiving chemotherapy for haematologic malignancies at intermediate to high risk of tumour lysis syndrome may require cardiac monitoring.
Hepatic effects: Serum aminotransferase (i.e., AST, ALT) concentrations exceeding 3 times the upper limit of normal (ULN) and hepatic failure have been reported in patients receiving febuxostat.
Liver function test (serum ALT, AST, alkaline phosphatase, and total bilirubin concentrations) should be performed prior to initiation of febuxostat therapy and repeated promptly in patients with manifestations suggestive of liver damage, such as fatigue, anorexia, right upper abdominal discomfort, dark-colored urine, or jaundice. If aminotransferase concentrations are elevated (ALT exceeding 3 times the ULN), febuxostat therapy should be interrupted and the cause of the abnormalities investigated. If an alternate etiology is not found, febuxostat therapy should not be restarted.
Dermatologic and hypersensitivity reactions: Serious dermatologic and hypersensitivity reactions (including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)), and hypersensitivity reactions have been reported in patients receiving febuxostat. Febuxostat should be used with caution in patients with history of dermatologic reactions to allopurinol.
Febuxostat should be discontinued if serious dermatologic reactions (e.g., rash; peeling or blistering of the skin; swelling or blistering of the lips, eyes, or mouth) are suspected.
Thyroid disorders: An increase in thyroid-stimulating hormone (TSH) concentrations (>5.5 µIU/mL) with treatment with febuxostat (5.5%) was reported. About 8% and 4% of subjects treated with febuxostat and allopurinol, respectively, showed raised TSH levels with no effect on free T4 and, consequently, this side effect may not be of any clinical relevance.