WARNING: CARDIOVASCULAR DEATH
Gout patients with established cardiovascular (CV) disease treated with ULORIC had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC. ULORIC should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
- ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
- Cardiovascular Death: In a CV outcomes study, there was a higher rate of CV death in patients treated with ULORIC compared to allopurinol; in the same study ULORIC was non-inferior to allopurinol for the primary endpoint of major adverse cardiovascular events (MACE). Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC.
- Gout Flares: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., NSAIDs or colchicine) upon initiation of treatment may be beneficial for up to six months.
- Hepatic Effects: Postmarketing reports of hepatic failure, sometimes fatal, have been received. Causality cannot be excluded. During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% in ULORIC and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted.
Obtain liver tests before starting treatment with ULORIC. Use caution in patients with liver disease. If liver injury is detected, promptly interrupt ULORIC and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart treatment if liver injury is confirmed and no alternate etiology can be found.
- Serious Skin Reactions: Postmarketing reports of serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN) have been reported in patients taking ULORIC. Discontinue ULORIC if serious skin reactions are suspected.
- Adverse reactions occurring in at least 1% of ULORIC-treated patients, and at least 0.5% greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash.
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.