FEBUXOSTAT tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E)

Available from:

Ascend Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Febuxostat tablet 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. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablet is not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)]. 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 that produced maternal exposures up to 40 and 51 times,

Product summary:

Febuxostat 40 mg tablets are light green to green in colour, round shaped coated tablets, debossed with "F40" on one side and plain on the other side and supplied as: NDC Number     Size 67877-668-30     Bottle of 30 Tablets 67877-668-90     Bottle of 90 Tablets 67877-668-10     Bottle of 1000 Tablets 67877-668-38     Hospital Unit Dose Pack of 100 Tablets Febuxostat 80 mg tablets are light green to green in colour, tear drop shaped coated tablets, debossed with "F80" on one side and plain on the other side and supplied as: NDC Number     Size 67877-669-30     Bottle of 30 Tablets 67877-669-01     Bottle of 100 Tablets 67877-669-10     Bottle of 1000 Tablets 67877-669-38     Hospital Unit Dose Pack of 100 Tablets Protect from light. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].  

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEBUXOSTAT - FEBUXOSTAT TABLET, FILM COATED
ASCEND LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FEBUXOSTAT TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FEBUXOSTAT TABLETS.
FEBUXOSTAT TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: CARDIOVASCULAR DEATH
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
GOUT PATIENTS WITH ESTABLISHED CARDIOVASCULAR (CV) DISEASE TREATED
WITH FEBUXOSTAT
HAD A HIGHER RATE OF CV DEATH COMPARED TO THOSE TREATED WITH
ALLOPURINOL IN A CV
OUTCOMES STUDY. (5.1) CONSIDER THE RISKS AND BENEFITS OF FEBUXOSTAT WHEN DECIDING TO
PRESCRIBE OR
CONTINUE PATIENTS ON FEBUXOSTAT. 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 FOR WHOM TREATMENT WITH ALLOPURINOL IS
NOT ADVISABLE. (1)
RECENT MAJOR CHANGES
Boxed Warning 2/2019
Indications and Usage 2/2019
Warnings and Precautions
Cardiovascular Death (5.1) 2/2019
INDICATIONS AND USAGE
Febuxostat tablet 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. (1)
For the safe and effective use of allopurinol, see allopurinol
prescribing information.
Limitations of Use:
Febuxostat tablet are not recommended for the treatment of
asymptomatic hyperuricemia. (1) (1)
DOSAGE AND ADMINISTRATION
Recommended febuxostat tablets dosage is 40 mg or 80 mg once daily.
The recommended starting
dose 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. (2.1)
Can be administered without regard to food or antacid use. (2.1)
Limit the dosage of febuxostat tablets to 40 mg once daily in patients
with severe rena