Febuxostat

What it is and how it works

Mechanism of Action Febuxostat, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Mechanism class: Xanthine Oxidase Inhibitors

Indications

Febuxostat Tablets are 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. Limitations of Use: Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat Tablets are 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. Limitations of Use: Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia.

Dosage and administration (summary)

• Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. • Patients with severe renal impairment: Limit the dosage to 40 mg once daily. ( 2.2 , 8.6 ) • Flare prophylaxis is recommended upon initiation of Febuxostat Tablets. • Can be administered without regard to food or antacid use. Recommended Dosage The recommended febuxostat dosage is 40 mg or 80 mg once daily. The recommended starting dosage of febuxostat is 40 mg once daily.

Contraindications

Febuxostat Tablets are contraindicated in patients being treated with azathioprine or mercaptopurine . Febuxostat Tablets are contraindicated in patients being treated with azathioprine or mercaptopurine.

Warnings and precautions

• Gout Flares : An increase in gout flares is frequently observed after initiation of febuxostat. If a gout flare occurs during treatment, febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug or colchicine) upon initiation of treatment may be beneficial for up to six months. ( 2.4 , 5.2 ) • Hepatic Effects : Cases of hepatic failure, some fatal, have been reported. If liver injury is detected, promptly interrupt febuxostat and treat cause, if possible, to resolution or stabilization.

Pregnancy

Pregnancy Risk Summary: Limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses…

Storage and supply

Febuxostat Tablets 40 mg are supplied as round, light green to green, biconvex tablet, debossed with "54 554" on one side and plain on the other side. NDC Number Size 0054-0413-13 bottle of 30 tablets Febuxostat Tablets 80 mg are supplied as round, light green to green, biconvex tablet, debossed with "54 244" on one side and plain on the other side…

Source: Febuxostat (Febuxostat) — US FDA prescribing information, 2023-05-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.