Generic Name: febuxostat
Date of Approval: February 13, 2009
Company: Takeda Pharmaceutical Company Limited
Treatment for: Hyperuricemia in Gout Patients
FDA Approves Uloric
The United States Food and Drug Administration (FDA) has approved Uloric (febuxostat) 40 mg and 80 mg for the chronic management of hyperuricemia in patients with gout.
Uloric, a xanthine oxidase inhibitor, effectively lowers levels of serum uric acid in patients with hyperuricemia associated with gout. It was studied and evaluated in multiple clinical trials involving more than 4,000 subjects, in some for up to five years.
The largest, pivotal, phase 3 clinical trial, CONFIRMS, demonstrated that Uloric 80 mg was superior to Uloric 40 mg and allopurinol 300/200 mg (67 percent, 45 percent and 42 percent, respectively) at achieving the primary end point of serum uric acid less than 6.0 mg/dL at the final visit (both p<0.001).
Uloric has an established safety profile with no dose adjustments required in patients with mild-to-moderate renal or hepatic impairment. The most commonly reported adverse reactions were liver function abnormalities, nausea, joint pain and rash.
About Gout and Hyperuricemia
Uric acid is an end-product created when the body breaks down substances called purines. Hyperuricemia occurs when this process results in elevated uric acid levels, either through overproduction or underexcretion of uric acid or a combination of the two. Hyperuricemia is a precursor to gout; the higher a person’s urate level, the greater the risk for developing gout.
Gout is a chronic condition characterized by attacks, or “flares,” marked by intense pain, redness, swelling and heat in the affected joint.
These symptoms are the result of an acute inflammatory response to the presence of crystallized uric acid in the joint(s). As the disease progresses, gout symptoms may become more frequent and patients may develop large deposits of crystallized uric acid visible under the skin, known as tophi.
About Uloric (febuxostat)
Uloric works by blocking the enzyme xanthine oxidase. Xanthine oxidase is responsible for the breakdown of the purine base, hypoxanthine, to xanthine, and then to uric acid. By blocking this enzyme, Uloric helps prevent uric acid production, thereby lowering elevated levels of serum uric acid.
Important Safety and Other Information
Uloric is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. Uloric is not recommended for the treatment of asymptomatic hyperuricemia.
Uloric is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline. An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Uloric. If a gout flare occurs during treatment, Uloric need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months. A higher rate of cardiovascular thromboembolic events was observed in patients treated with Uloric (0.74 per 100 patient-years) than allopurinol (0.60 per 100 patient-years) in clinical trials. A causal relationship with Uloric has not been established. Monitor for signs and symptoms of myocardial infarction (MI) and stroke. Transaminase elevations have been observed in Uloric-treated patients. No dose-effect relationship for these transaminase elevations was noted. Monitor liver function tests periodically. Adverse reactions occurring in at least 1 percent of Uloric- treated patients, and, at least 0.5 percent greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash.
Uloric Patient Information
Read the Patient Information that comes with Uloric before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Uloric?
Uloric is a prescription medicine called a xanthine oxidase (XO) inhibitor, used to lower blood uric acid levels in adults with gout.
It is not known if Uloric is safe and effective in children under 18 years of age.
Who should not take Uloric?
Do not take Uloric if you:
- take Azathioprine (Azasan, Imuran)
- take Mercaptopurine (Purinethol)
- take Theophylline (Theo-24, Elixophyllin, Theochron, Theolair, Uniphyl)
It is not known if Uloric is safe and effective in children under 18 years of age.
What should I tell my healthcare provider before taking Uloric?
Before taking Uloric tell your healthcare provider 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 provider 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 provider should decide if you should take Uloric while breast-feeding.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription 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 provider and pharmacist when you get a new medicine.
How should I take Uloric?
- Take Uloric exactly as your healthcare provider tells you to take it.
- Uloric can be taken with or without food.
- Uloric can be taken with antacids.
- Your gout may flare up when you start taking Uloric, do not stop taking your Uloric even if you have a flare. Your healthcare provider may give you other medicines to help prevent your gout flares.
- Your healthcare provider may do certain tests while you take Uloric.
What are the possible side effects of Uloric?
Heart problems. A small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that Uloric caused these events.
The most common side effects of Uloric include:
- liver problems
- nausea
- gout flares
- joint pain
- rash
Tell your healthcare provider 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 information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store Uloric?
Store Uloric between 59°F – 86°F (15°C – 30°C).
Keep Uloric out of the light.
Keep Uloric and all medicines out of the reach of children.
General information about the safe and effective use of Uloric.
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Uloric for a condition for which it was not prescribed. Do not give Uloric to other people, even if they have the same symptoms that you have. It may harm them.
This patient information leaflet summarizes the most important information about Uloric. If you would like more information about Uloric talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Uloric that is written for health professionals. For more information go to www.uloric.com, or call 1-877-825-3327.
What are the ingredients in Uloric?
Active Ingredient: febuxostat
Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide, magnesium stearate, and Opadry II, green
For more information, please visit www.uloric.com.
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