FEBUXOSTAT tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

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. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)] . Risk Summary Limited available data with febuxostat tablets 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, respectively, the exposure at the maximum recommended human dose (MRHD). No adverse developmental effects were observed in a pre- and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the MRHD (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation Days 7 – 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation Days 6 – 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day). In a pre- and postnatal development study in pregnant female rats dosed orally from gestation Day 7 through lactation Day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the MRHD (on an AUC basis at a maternal oral dose of 12 mg/kg/day). However, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the MRHD (on an AUC basis at a maternal oral dose of 48 mg/kg/day). Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues. Risk Summary There are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. Febuxostat is present in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for febuxostat tablets and any potential adverse effects on the breastfed child from febuxostat tablets or from the underlying maternal condition. Data Animal Data Orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration. Safety and effectiveness of febuxostat tablets in pediatric patients have not been established. No dose adjustment is necessary in elderly patients. Of the total number of patients in Studies 1, 2, and 3 (clinical studies of febuxostat tablets in the treatment of gout) [see Clinical Studies (14.1)] , 16% were 65 and over, while 4% were 75 and over. Comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out. The C max and AUC 24 of febuxostat following multiple oral doses of febuxostat tablets in geriatric patients (≥ 65 years) were similar to those in younger patients (18 to 40 years) [see Clinical Pharmacology (12.3)]. No dose adjustment is necessary in patients with mild to moderate renal impairment (Cl cr 30 to 89 mL/min). For patients with severe renal impairment (Cl cr 15 to 29 mL/min), the recommended dosage of febuxostat tablets is limited to 40 mg once daily [see Dosage and Administration (2.2)and Clinical Pharmacology (12.3)]. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C); therefore, caution should be exercised in these patients [see Clinical Pharmacology (12.3)]. No studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); febuxostat tablets are not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, Lesch-Nyhan syndrome). The concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.

Product summary:

Febuxostat tablets 40 mg are white or almost white round film-coated tablets, debossed with “C33” on one side and blank on the other side and supplied as: Febuxostat tablets 80 mg are white or almost white capsule-shaped film-coated tablets, debossed with “C32” on one side and blank on the other side and supplied as: 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

Patient Information leaflet

Lannett Company, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: May 2021
MEDICATION GUIDE
FEBUXOSTAT (fe bux' oh stat)
tablets, for oral use
Read the Medication Guide that comes with febuxostat tablets before
you start taking it and each time you
get a refill. There may be new information. The Medication Guide does
not take the place of talking with
your doctor about your medical condition or your treatment.
What is the most important information that I should know about
febuxostat tablets?
Febuxostat tablets may cause serious side effects, including:
Heart-related deaths.
Call your doctor or get emergency medical help right away if you have
any of the following symptoms,
especially if they are new, worse, or worry you:
•
chest pain
•
shortness of breath or trouble breathing
•
dizziness, fainting or feeling lightheaded
•
rapid or irregular heartbeat
•
numbness or weakness in
one side of your body
•
slurring of speech
•
sudden blurry vision or
sudden severe headache
What are febuxostat tablets?
Febuxostat tablet is a prescription medicine called a xanthine oxidase
(XO) inhibitor used to lower blood
uric acid levels in adult patients with gout when allopurinol has not
worked well enough or when allopurinol
is not right for you.
Febuxostat tablets are not for use in people who do not have symptoms
of high blood uric acid levels.
It is not known if febuxostat tablets are safe and effective in
children.
Who should not take febuxostat tablets?
Do not take febuxostat tablets if you:
•
take azathioprine (Azasan, Imuran)
•
take mercaptopurine (Purinethol, Purixan)
What should I tell my doctor before taking febuxostat tablets?
Before taking febuxostat tablets tell your doctor about all of your
medical conditions, including if you:
•
have taken allopurinol and what happened to you while you were taking
it.
•
have a history of heart disease or stroke.
•
have liver or kidney problems.
•
are pregnant or plan to become pregnant. It is not known

Summary of Product characteristics

FEBUXOSTAT- FEBUXOSTAT TABLET
LANNETT COMPANY, INC.
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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
TABLETS 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 TABLETS WHEN DECIDING TO
PRESCRIBE OR
CONTINUE PATIENTS ON FEBUXOSTAT TABLETS. FEBUXOSTAT TABLETS 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)
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)
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of
asymptomatic hyperuricemia. ( 1)
DOSAGE AND ADMINISTRATION
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. ( 2.1)
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. ( 2.4)
Can be administered without regard to food or antacid use. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. ( 3)
CONTRAINDICATIONS
Febuxostat tablets are contraindicated in patients being treat