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:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Febuxostat tablets are 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 tablets are 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 an

Product summary:

Febuxostat 40 mg tablets are green colored, round shaped, biconvex, film coated tablets, debossed with "40" on one side and "F" on other side and supplied as: Bottles of 30 tablets……….………....….... (NDC 72205-028-30) Bottles of 90 tablets……………………..... (NDC 72205-028-90) Bottles of 500 tablets……..……………..... (NDC 72205-028-05) Febuxostat 80 mg tablets yellow colored, capsule shaped, biconvex, film coated tablets, debossed with "80" on one side and plain on other side and supplied as:    Bottles of 30 tablets……………………...... (NDC 72205-029-30) Bottles of 100 tablets…………………….... (NDC 72205-029-91) Bottles of 1000 tablets…………………...... (NDC 72205-029-99) Protect from light. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEBUXOSTAT - FEBUXOSTAT TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 tablets are xanthine oxidase (XO) inhibitor indicated for
the chronic management of hyperuricemia in 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 tablets are not recommended for the treatment of
asymptomatic hyperuricemia. (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 se