Complete SPL Sections
WARNING: CARDIOVASCULAR DEATH
Boxed Warning Section
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 [see Warnings and Precautions (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 [see Indications and Usage (1)] .
1 INDICATIONS AND USAGE
Indications & Usage Section
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. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
2 DOSAGE AND ADMINISTRATION
Dosage & Administration Section
3 DOSAGE FORMS AND STRENGTHS
Dosage Forms & Strengths Section
40 mg tablets, round, biconvex, green colored, film-coated tablets with ‘721’ debossed on one side and plain on other side. 80 mg tablets, oval, biconvex, green colored, film-coated tablets with ‘722’ debossed on one side and plain on other side.
4 CONTRAINDICATIONS
Contraindications Section
Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)] .
5 WARNINGS AND PRECAUTIONS
Warnings And Precautions Section
6 ADVERSE REACTIONS
Adverse Reactions Section
The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death [see Warnings and Precautions (5.1)] Hepatic Effects [see Warnings and Precautions (5.3)] Serious Skin Reactions [see Warnings and Precautions (5.4)]
7 DRUG INTERACTIONS
Drug Interactions Section
8 USE IN SPECIFIC POPULATIONS
Use In Specific Populations Section
10 OVERDOSAGE
Overdosage Section
Febuxostat was studied in healthy patients in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose of febuxostat was reported in clinical studies. Patients should be managed by symptomatic and supportive care should there be an overdose.
11 DESCRIPTION
Description Section
Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat tablets is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The molecular formula is C 16 H 16 N 2 O 3 S. The chemical structure is: Febuxostat is a non-hygroscopic, white to off white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulphoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 200°C to 202°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, sodium lauryl sulfate, hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate. Febuxostat tablets are coated with polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake and iron oxide yellow.
12 CLINICAL PHARMACOLOGY
Clinical Pharmacology Section
13 NONCLINICAL TOXICOLOGY
Nonclinical Toxicology Section
14 CLINICAL STUDIES
Clinical Studies Section
A serum uric acid level of less than 6 mg/dL is the goal of antihyperuricemic therapy and has been established as appropriate for the treatment of gout.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied Section
Febuxostat 40 mg tablets are round, biconvex, green colored, film-coated tablets with ‘721’ debossed on one side and plain on other side and supplied as: NDC Number Size 16714-059-01 Bottle of 30 Tablets with Child Resistant Cap Febuxostat 80 mg tablets are oval, biconvex, green colored, film-coated tablets with ‘722’ debossed on one side and plain on other side and supplied as: NDC Number Size 16714-060-01 Bottle of 30 Tablets with Child Resistant Cap Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Information For Patients Section
Advise the patient to read the FDA-approved patient labeling (Medication Guide). CV Death Inform patients that gout patients with established CV disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. Inform all patients of the higher rate of CV death with febuxostat tablets compared to allopurinol. Alert all patients (those with and without CV disease) for the development of signs and symptoms of CV events and to seek medical care promptly should they occur [see Warnings and Precautions (5.1)] . Gout Flares Inform patients that after initiation of febuxostat tablets an increase in gout flares can occur and that is not reason to stop taking the medication. Instruct patients that it is recommended to initiate and continue gout prophylaxis therapy for six months while taking febuxostat tablets [see Warnings and Precautions (5.2)] . Hepatic Effects Inform patients that hepatic effects, including fatal ones, have occurred in patients treated with febuxostat tablets. Instruct them to inform their healthcare provider if they experience liver injury symptoms [see Warnings and Precautions (5.3)] . Serious Skin Reactions Inform patients that serious skin and hypersensitivity reactions have occurred in patients treated with febuxostat tablets. Instruct patients to discontinue febuxostat tablets if they develop symptoms of these reactions [see Warnings and Precautions (5.4)] . Medication guide available at www.northstarrxllc.com/products or call 1-800-206-7821
MEDICATION GUIDE
SPL MEDGUIDE SECTION
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 numbness or weakness on one side of your body shortness of breath or trouble breathing slurring of speech dizziness, fainting or feeling lightheaded sudden blurry vision or sudden severe headache rapid or irregular heartbeat What are febuxostat tablets? Febuxostat tablets are 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 if febuxostat tablets will harm your unborn baby. Talk with your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if febuxostat passes into your breast milk. You and your doctor should decide if you should take febuxostat tablets while breastfeeding. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Febuxostat tablets may affect the way other medicines work, and other medicines may affect how febuxostat tablets work. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take febuxostat tablets? Take febuxostat tablets exactly as your doctor tells you to take them. Febuxostat tablets can be taken with or without food. Febuxostat tablets can be taken with antacids. Your gout may get worse (flare) when you start taking febuxostat tablets. Do not stop taking febuxostat tablets because you have a flare. Your doctor may do certain tests while you take febuxostat tablets. What are the possible side effects of febuxostat tablets? Febuxostat tablets may cause serious side effects, including: Heart problems. See “What is the most important information I should know about febuxostat tablets?”. Gout Flares. Gout flares can happen when you start taking febuxostat tablets. Your doctor may give you other medicines to help prevent your gout flares. Liver problems. Liver problems can happen in people who take febuxostat tablets. Your doctor may do blood tests to check how well your liver is working before and during your treatment with febuxostat tablets. Tell your doctor if you get any of the following signs or symptoms of liver problems: fatigue loss of appetite for several days or longer pain, aching, or tenderness on the right side of your stomach-area dark or “tea-colored” urine your skin or the white part of your eyes turns yellow (jaundice) Severe skin and allergic reactions. Serious skin and allergic reactions that may affect different parts of the body such as your liver, kidneys, heart or lungs, can happen in people who take febuxostat tablets. Call your doctor right away or get emergency medical help if you have any of the following symptoms: rash sores around the lips, eyes or mouth red and painful skin swollen face, lips, mouth, tongue or throat severe skin blisters flu-like symptoms peeling skin The most common side effects of febuxostat tablets include: abnormal liver function tests joint pain nausea rash These are not all of the possible side effects of febuxostat tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store febuxostat tablets? · Store febuxostat tablets at 20° to 25°C (68° to 77°F). · Keep febuxostat tablets out of the light. · Febuxostat tablets come in a child-resistant package. Keep febuxostat tablets and all medicines out of the reach of children. General information about the safe and effective use of febuxostat tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use febuxostat tablets for a condition for which they were not prescribed. Do not give febuxostat tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your doctor or pharmacist for information about febuxostat tablets that is written for health professionals. What are the ingredients in febuxostat tablets? Active ingredient: febuxostat Inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, sodium lauryl sulfate, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate. Febuxostat tablets are coated with polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake and iron oxide yellow. Medication guide available at www.northstarrxllc.com/products or call 1-800-206-7821. * All trademarks are the property of their respective owners. Manufactured for: NorthStar Rx LLC Memphis, TN 38141. Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. For more information, call 1-800-206-7821. This Medication Guide has been approved by the U.S. Food and Drug Administration 5246182 ISS. 10/2023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-40mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 16714-059-01 Febuxostat Tablets 40 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only 30 Tablets NORTHSTAR
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-80mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC16714-060-01 Febuxostat Tablets 80 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only 30 Tablets NORTHSTAR