Febuxostat

Febuxostat lowers the amount of uric acid made in your body. Having too much uric acid can lead to gout symptoms.

Febuxostat is used to prevent uric acid levels from becoming too high in people with gout.

Febuxostat is meant for people who cannot take another medicine called allopurinol, or when allopurinol is no longer effective.

Febuxostat may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

You can take febuxostat with or without food. You can also take febuxostat with an antacid if needed.

You may experience an increase in gout symptoms (flares) when you first start taking febuxostat. Your doctor may prescribe other medications for you to use during the first 6 months of treatment with febuxostat.

You should not stop using febuxostat suddenly. Stopping suddenly may make your condition worse.

For the best results, continue using your medications as directed. Call your doctor if your symptoms do not improve after 6 months, or if they get worse.

You will need frequent blood tests to check your liver function.

Store at room temperature away from moisture, heat, and light.

Taking febuxostat may raise your chances of serious or life-threatening heart issues. Get medical help if you experience chest pain, difficulty breathing, rapid heartbeats, a sudden severe headache, numbness or weakness on one side of your body, or issues with your vision or speech.

You should not use febuxostat if you are also taking azathioprine or mercaptopurine.

You should not use febuxostat if you are allergic to it, or if you also use:

• azathioprine; or
• mercaptopurine.

Taking febuxostat may increase your risk of serious or fatal heart problems. Talk with your doctor about the risks and benefits of febuxostat.

Tell your doctor if you have ever had:

• heart problems;
• a heart attack or stroke;
• liver or kidney disease;
• cancer;
• Lesch-Nyhan syndrome; or
• an organ transplant (kidney, liver, lung, heart).

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Febuxostat may cause serious side effects. Call your doctor right away if you have:

• a light-headed feeling, like you might pass out;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, fast heartbeats, shortness of breath;
• liver problems--stomach pain (upper right side), unusual tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects of febuxostat may include:

• gout flares, joint pain;
• nausea;
• mild rash; or
• liver problems.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Gout:

Initial dose: 40 mg orally once a day-If serum uric acid level is greater than 6 mg/dL after 2 weeks, increase the dose to 80 mg orally once a dayMaintenance dose: 40 to 80 mg orally once a dayMaximum dose: 80 mg/dayComments:-Use of this drug should occur after an acute gout flare subsides.-Gout flares may occur due to increased urate mobilization from tissue deposits, especially during initiation; gout flare prophylaxis with a NSAID or colchicine is recommended and may be beneficial for up to 6 months.-Uric acid levels may be checked as soon as 2 weeks after beginning this drug.Use: For the chronic management of hyperuricemia in patients with gout who have an inadequate experience to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

Take the medicine as soon as you remember, but if it is nearly time for your next dose, skip the missed dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all your other medicines, especially:

• theophylline.

This list is not complete. Other drugs may affect febuxostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.