Rivex 80 Special Precautions

Cardiovascular: Treatment with Febuxostat in patients with ischemic heart disease or congestive heart disease is not recommended. Cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) have been reported. Gout patients with established cardiovascular disease had a higher rate of cardiovascular death when treated with Febuxostat compared to patients treated with allopurinol in a cardiovascular outcomes study. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or when treatment with allopurinol is not advisable. Consider risks and benefits when prescribing or continuing Febuxostat therapy. Consider prophylactic low-dose aspirin in patients with a history of cardiovascular disease. Monitor patients for signs and symptoms of cardiovascular events.
Dermatologic: Serious skin and hypersensitivity reactions, including Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis, have been reported. Discontinue use if suspected. Use with caution in patients with previous similar skin reactions to allopurinol.
Endocrine and Metabolic: Use is not recommended with conditions which greatly increase urate formation rate (eg, malignant disease and treatment, Lesch-Nyhan syndrome).
Hepatic: Postmarketing cases of hepatic failure (both fatal and nonfatal) have been reported (causal relationship has not been established). Liver function tests should be evaluated at baseline and periodically thereafter. Evaluate liver function tests promptly in patients experiencing signs and symptoms of hepatic injury (eg, fatigue, liver function tests (eg, ALT >3 x ULN). Permanently discontinue use if no other explanation for the abnormalities is elucidated and in patients who develop ALT >3 x ULT and serum total bilirubin >2 x ULN. All other patients may be cautiously restarted on Febuxostat. Use with caution in patients with severe hepatic impairment (Child-Pugh class C); has not been studied.
Musculoskeletal: Increase in gout flares may occur after initiating treatment. Prophylactic treatment is recommended. Administer concurrently with an NSAID or colchicine (up to 6 months) to prevent gout flare.