Uloric (febuxostat)

Gout is a painful form of arthritis. Gout is best known to many people because of its extremely painful attacks. These attacks often happen without warning, make it hard to get around, and can last from hours to weeks.

Gout is caused by a buildup of uric acid. This buildup is also known as hyperuricemia ('hi-per-'yuri-'seem-ee-uh), the medical name for high uric acid in the blood.

When you have high uric acid, it can form crystals in your joints. These crystals cause inflammation that can lead to extremely painful gout attacks. Someone may have high uric acid and never have an attack, or have it for years before their first gout attack.

Learn about what causes gout in more detail.

Everyone has uric acid in his or her body. It comes from substances called purines. Most uric acid comes from purines made naturally in your body. The rest comes from purines in your diet. Learn more about diet and purines.

If your body produces too much uric acid and/or your kidneys have trouble getting rid of it, uric acid builds up in your blood to higher-than-healthy levels. If you have gout, high uric acid buildup can lead to more attacks.

Most uric acid comes from purines made naturally by the body

Gout may be best known for causing severe pain in the toe. In fact, most gout attacks (76%) do occur in the big toe. You may be surprised to learn that gout attacks can occur in other parts of the body as well. One survey of people with gout showed that attacks occurred in the:

• Big toe (76%)
• Ankle or foot (50%)
• Knee (32%)
• Finger (25%)
• Elbow (10%)
• Wrist (10%)
• More than one site (11%)

It is hard to say exactly what triggers an attack. They sometimes occur for no apparent reason. . .other times, something may seem to trigger the attack. Gout attacks may be triggered by alcohol, certain medicines, another illness, stressful events, or other factors.

Other known gout triggers include:

• Joint injury
• Eating too much of certain foods
• Infection
• Surgery
• Crash diets
• Rapid lowering of uric acid levels with uric acid-lowering medicines
• Some cancer treatments

Learn more about gout attacks.

Yes. If you have gout, high uric acid levels can lead to more attacks. To help reduce future gout attacks, lower your uric acid to a healthy level. Keeping your uric acid level low (less than 6 mg/dL) is the goal for long-term management of gout.

There are 2 parts when it comes to treating gout; both are equally important. Your healthcare professional may give you medicine to treat your symptoms (the pain and swelling of a gout attack) and medicine to treat the root cause of gout (high uric acid).

Nobody who’s experienced a gout attack is likely to question the importance of pain relief. But medicines to reduce pain and swelling don’t address the root cause of gout. For that, you’ll need a medication that helps lower your uric acid to a healthy level and keep it there. Over time, this can reduce future gout attacks. Learn about treatment to lower uric acid levels.

You should discuss an overall treatment plan approach with your healthcare professional, which may also include:

• Maintaining a healthy lifestyle and diet
• Having your uric acid checked occasionally as directed by your healthcare professional to ensure it is at a healthy level (less than 6 mg/dL)
• Keeping your doctor informed about your gout flares, including how many and how long they last

There’s no denying that important steps like drinking plenty of nonalcoholic beverages (lots of water, less alcohol), exercising, maintaining a healthy weight, and limiting high-purine foods are smart choices for people with gout. A healthy diet and lifestyle are good for you and should be a part of your comprehensive treatment plan.

However, research shows that diet alone may not be enough to get rid of the buildup of uric acid and help reduce future gout attacks. In most cases, even the strictest low-purine diet has been shown to reduce uric acid levels by about
1 mg/dL. See how diet measures up.

This Website is just one resource for information about gout and gout treatment. You can also join GoutSmart. GoutSmart provides education and information about gout and ULORIC.

This program is designed to help you:

• Take an active role in managing your gout
• Learn about the relationship between uric acid and gout
• Learn more about ULORIC, the first FDA-approved branded prescription medicine for lowering uric acid in adults with gout in more than 40 years
• Know what questions to ask and discuss with your healthcare professional

Living with gout? Sign up for our GoutSmart program now.

To further help manage your gout, you should discuss a treatment plan with your healthcare professional, which may include:

• Maintaining a healthy lifestyle and diet
• Taking medicine to lower your uric acid level and medicine to manage the pain and swelling caused  by your gout attacks
• Having your uric acid level checked occasionally as directed by your healthcare professional to ensure it is at a healthy level
  (less than 6 mg/dL)
• Keeping your doctor informed about your gout flares, including how many and how long they last

ULORIC is the first FDA-approved branded prescription medicine for lowering uric acid in adults with gout in more than 40 years! It’s a prescription medicine called a xanthine oxidase (XO) inhibitor that is used to lower blood uric acid levels in adults with gout. It is not for the treatment of high uric acid in people without a history of gout. Learn more about ULORIC.

Uric acid comes from substances called purines. Your body makes purines, and they also come from some things you eat and drink. ULORIC works in adults with gout by stopping the body from turning purines into uric acid. Research shows that keeping your uric acid level low can reduce future gout attacks over time. Learn more about lowering uric acid.

Allopurinol is another medicine often prescribed to lower uric acid levels. Research has shown several key differences between ULORIC and allopurinol:

• ULORIC 40 mg was similar, and ULORIC 80 mg was significantly better at helping patients reach a healthy uric acid level (less than 6 mg/dL) compared with allopurinol.
• Up to twice as many patients reached a healthy uric acid level
  (less than 6 mg/dL) while taking ULORIC 80 mg compared with allopurinol.
• Unlike patients using allopurinol, patients with mild to moderate kidney problems do not have to change doses with ULORIC.*
• More patients with mild to moderate kidney problems reached a healthy uric acid level (less than 6 mg/dL) while taking ULORIC compared with allopurinol.

*Only a small number of patients with severe kidney problems were studied with ULORIC. If you have kidney problems, ask your healthcare professional about the differences between medicines used to lower uric acid levels.

See how ULORIC can fit into your treatment plan.

With ULORIC, you may have another treatment option to discuss with your healthcare professional. Some key points to keep in mind:

• Unlike patients using allopurinol, patients with mild to moderate kidney problems do not have to change doses with ULORIC.*
• More patients with mild to moderate kidney problems reached a healthy uric acid level (less than 6 mg/dL) while taking ULORIC compared with allopurinol.

*Only a small number of patients with severe kidney problems were studied with ULORIC. If you have kidney problems, ask your healthcare professional about the differences between medicines used to lower uric acid levels.

Learn about Safety & Side Effects.

If you’re beginning treatment with ULORIC, it’s important that you follow your healthcare professional’s instructions carefully. ULORIC is taken daily, with or without food, so you can make taking ULORIC part of your daily routine. ULORIC can be taken with antacids. Learn about Getting Started With ULORIC

Gout may flare up when you start taking medicine (e.g., ULORIC, allopurinol, and probenecid) to lower your uric acid. This may be caused when crystals begin to dissolve in your joints as your uric acid level goes down. Your healthcare professional may tell you to take other medicines to help prevent or manage flares during initial treatment. If your healthcare professional gives you medicine to lower your uric acid, you should keep taking it, even between attacks.

Learn why staying on ULORIC is important for managing gout.

ULORIC may cause side effects in some people. The most common are:

• Liver problems
• Nausea
• Gout flares
• Joint pain
• Rash

Tell your healthcare professional if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ULORIC. For more detailed information about side effects, ask your healthcare professional or pharmacist, or click here for Prescribing Information.

Do not take ULORIC if you take:

• Azathioprine
• Mercaptopurine

It is not known if ULORIC is safe and effective in children with gout under 18 years of age.

Before taking ULORIC, tell your healthcare professional about all of your medical conditions, including if you:

• Have liver or kidney problems
• Have a history of heart disease or stroke
• Are pregnant or plan to become pregnant. It is not known if ULORIC will harm your unborn baby. Talk with your healthcare professional if you are pregnant or plan to become pregnant.
• Are breast-feeding or plan to breast-feed. It is not known if ULORIC passes into your breast milk. You and your healthcare professional should decide if you should take ULORIC while breast-feeding.

Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ULORIC may affect the way other medicines work, and other medicines may affect how ULORIC works. Know the medicines you take. Keep a list of them, and show it to your healthcare professional and pharmacist when you get a new medicine.

• Store ULORIC between 59ºF-86ºF (15ºC-30ºC).
• Keep ULORIC out of the light.
• Keep ULORIC and all medicines out of the reach of children.

Yes. With the ULORIC Savings Card, eligible patients will pay no more than $35*, subject to a maximum benefit of $160, for ULORIC prescriptions and each refill until March 31, 2012. Just take your ULORIC Savings Card with you when you get your prescription filled and present it to the pharmacist.

In addition to getting these savings, you will also be enrolled in the GoutSmart program, a personalized educational series of e-newsletters that allows you to select topics that most appeal to you.

Save on prescriptions* and stay informed with GoutSmart.

* Must meet eligibility requirements.

Takeda believes all patients should have access to the medication prescribed by their healthcare providers. We also understand that some patients may have financial situations that make it difficult to pay for their prescriptions.

Help At Hand provides patients with three options for receiving free or low-cost medications:

• Patient Assistance Program (PAP) — qualified patients can receive free Takeda medication
• Together Rx Access® — savings at the pharmacy for patients who might not qualify for PAP
• Partnership for Prescription Assistance (PPA) — helps qualifying patients without prescription drug coverage get the medicines they need

For more information about Takeda Help At Hand, visit www.takedahelpathand.com.