Lesinurad may cause serious kidney problems. Tell your doctor if you are being treated with dialysis (treatment to clean the blood when the kidneys are not working well), have received a kidney transplant, or have or have ever had kidney disease. The risk that you will develop serious kidney problems is greater if you are taking lesinurad alone. Lesinurad must be taken in combination with a xanthine oxidase inhibitor such as allopurinol (Lopurin, Zyloprim) or febuxostat (Uloric). If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, or upper right stomach pain.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before and during treatment to check your body’s response to lesinurad.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with lesinurad and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Lesinurad is used in combination with a xanthine oxidase inhibitor to treat hyperuricemia (high levels of uric acid) in people with gout (sudden attacks of redness, swelling, pain, and heat in one or more joints) whose disease is not controlled with their current medication. Lesinurad is in a class of medications called selective uric acid reabsorption inhibitors. It works by helping the kidneys to remove uric acid from the body.

Lesinurad comes as a tablet to take by mouth. It is usually taken once daily in the morning with food and water. Take lesinurad at around the same time every day and at the same time that you take a xanthine oxidase inhibitor such as allopurinol (Lopurin, Zyloprim) or febuxostat (Uloric). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lesinurad exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lesinurad controls hyperuricemia in people with gout but does not cure it. Your gout may flare up (intense painful, swelling joint) when you first start taking lesinurad, but do not stop taking it. Your doctor will give you other medications to help prevent gout flares. Continue to take lesinurad even if you feel well or have a gout attack. Do not stop taking lesinurad without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lesinurad,

• Tell your doctor and pharmacist if you are allergic to lesinurad, any other medications, or any of the ingredients in lesinurad tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Nexterone, Pacerone), amlodipine (Norvasc), aspirin, carbamazepine (Epitol, Equetro, Teril, others), fluconazole (Diflucan), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), sildenafil (Revatio, Viagra), or valproic acid (Depakene). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lesinurad, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, tumor lysis syndrome (a condition that causes cancer cells to break down quickly and release byproducts into the blood), or Lesch-Nyhan syndrome (an inherited disease that causes high levels of uric acid in the blood). Your doctor will probably tell you not to take lesinurad.
• Tell your doctor if you have or have ever had a stroke, a heart attack, high blood pressure, heart disease, high cholesterol, or liver disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Hormonal contraceptives (birth control pills, patches, rings, shots, implants, and intrauterine devices) may not work well when used with lesinurad and should not be used as your only method of birth control. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking lesinurad, call your doctor.

Drink at least 68 ounces (2 liters) of water or other fluids every 24 hours while taking lesinurad unless directed to do otherwise by your doctor.

If you miss taking lesinurad in the morning, do not lake it later in the day. Continue your regular dosing schedule the next morning with food and water. Do not take a double dose to make up for a missed one.

Lesinurad may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Flu-like symptoms such as headache, fever, sweating, muscle aches, and tiredness
• Heartburn

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING sections, call your doctor immediately or get emergency medical treatment:

• Chest pain, pressure, or discomfort
• Shortness of breath or trouble breathing
• Weakness in one part or side of their body
• Slurred speech

Lesinurad may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.