Febuxostat (Page 8 of 9)
17 PATIENT COUNSELING INFORMATION
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. Instruct all patients (those with and without CV disease) to be alert for the development of signs and symptoms of CV events [see Warnings and Precautions (5.1)].
Gout Flares: Inform patients that after initiation of febuxostat tablets there was an increased frequency of gout flares. 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 have occurred in patients treated with febuxostat tablets and 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
| Febuxostat Tablets(fe bux′ oh stat) | |
| Read the Medication Guide that comes with febuxostat tablets before you start taking them 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: | |
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| 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:
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| 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:
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?
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:
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| The most common side effects of febuxostat tablets include: | |
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| 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?
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: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc and titanium dioxide Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited, Hyderabad – 500 096, India The brands listed are trademarks of their respective owners. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). | |
This Medication Guide has been approved by the U.S. Food and Drug Administration
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Hyderabad – 500 096, India
75058559
Revised: 3/2019
MX:FEBU:R2mmh/MX:MG:FEBU:R1m/MX:MG:FEBU:R1mh
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