Uloric

The active ingredient in Uloric is febuxostat. Febuxostat is a xanthine oxidase inhibitor, meaning that it stops an enzyme in the body from producing uric acid when it breaks down chemical compounds known as purines. Limiting the production of uric acid helps control gout flares, which are often the result of hyperuricemia or excess urate crystals.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Uloric. However, the following is a synopsis of the general guidelines for the use of Uloric:

• Uloric is typically taken by mouth once a day with or without food. Uloric may also be taken with an antacid.
• Use Uloric exactly as prescribed. Uloric may cause your gout to become worse when you first start using it but do not stop taking Uloric without first consulting your healthcare provider. To help decrease the risk of your gout worsening when you first start using Uloric, your doctor may prescribe colchicine or NSAIDs such as naproxen to be used daily alongside your Uloric. These may be continued for up to 6 months but your doctor will know what is best to recommend for you. Do not exceed the recommended dose or duration of use.
• Uloric is typically meant for use in patients with hyperuricemia that is gout-related. It should not be used for hyperuricemia seen in patients with Lesch-Nyhan syndrome or organ transplant recipients.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Uloric seen in clinical trials include:

• Nausea and stomach upset
• Arthralgia (joint pain)
• Skin rash
• Abnormal liver function tests. Your doctor may order blood tests to monitor your liver function before and during treatment with Uloric.

Some individuals may experience serious side effects while using Uloric. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a liver injury or impairment such as fatigue, jaundice or yellowing of the skin and eyes, dark urine, or right-sided upper abdominal pain
• Signs of severe allergic reactions or skin reactions such as a widespread rash with fever, hives, blisters, peeling of the skin, swelling of the face or eyes, and painful sores. If left untreated, it could progress to life-threatening drug reactions such as Stevens-Johnson Syndrome, DRESS, and TEN
• Signs of a serious heart condition such as chest pain, shortness of breath, dizziness or lightheadedness, rapid or irregular heartbeat, numbness or weakness on one side of your body, slurred speech, sudden change in vision, or a sudden or severe headache

These are not all of the possible side effects of Uloric. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Uloric, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Used allopurinol in the past and what happened while taking it
• A history of heart disease, heart attack, stroke, or other heart problems
• Hepatic or liver problems
• Renal or kidney problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• Uloric can increase the rate of cardiovascular-related deaths in gout patients with a history of heart disease. Allopurinol may be a safer option in these patients.

Do not use Uloric if you are using:

• Azathioprine
• Mercaptopurine

Uloric does take some time to work. The effects of febuxostat (Uloric) may not be seen for many weeks. Regular use will help lower serum uric acid levels in the long term to help reduce your chance of future gout flares. Uloric may worsen gout at the start but it is important to continue taking unless told otherwise by your healthcare provider.

When Uloric is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Azathioprine
• Mercaptopurine
• Theophylline

Uloric is available in the following strengths:

• 40 mg tablet
• 80 mg tablet

Uloric should be stored at room temperature away from moisture, heat, or light, and out of reach of children.

Uloric is manufactured by the Takeda Pharmaceutical Company.

Yes, there is a generic version of the brand name Uloric available.

Uloric is generally a long-term medication that patients with gout need to take daily for chronic management of gout flares. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Uloric.

It is unknown whether Uloric can harm your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Uloric can pass into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.