Febuxostat

Postmarketing cases of hepatic failure (both fatal and nonfatal) have been reported (causal relationship has not been established). In controlled studies, significant hepatic transaminase elevations (>3 x ULN) have occurred (causal relationship not 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, anorexia, right upper quadrant pain, dark urine, jaundice). Interrupt therapy in patients who develop abnormal 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.

Hypersensitivity and serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS) have been reported, particularly in patients with prior skin reactions to allopurinol; use with caution if a patient has a history of hypersensitivity reaction to allopurinol.

MI, stroke and cardiovascular deaths were reported at a slightly increased rate versus allopurinol in controlled studies (a causal relationship has not been established). Patients should be monitored for signs and symptoms of MI or stroke. Disease-related concerns:

Use with caution in patients with severe hepatic impairment (Child-Pugh class C); has not been studied.

Use in secondary hyperuricemia has not been studied; avoid use in patients at increased risk of urate formation (eg, malignancy and its treatment; Lesch-Nyhan syndrome). Dosage forms specific issues:

Contains lactose. Other warnings/precautions:

Administer concurrently with an NSAID or colchicine (up to 6 months) to prevent gout flare, which may occur upon initiation of therapy. Do not use to treat asymptomatic or secondary hyperuricemia.