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General Information

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IMPORTANT WARNING:

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.

Use

WHY is this medicine prescribed?

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.

HOW should this medicine be used?

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.

Are there OTHER USES for this medication?

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

Special

What SPECIAL PRECAUTIONS should I follow?

Before taking lesinurad,

What SPECIAL DIETARY instructions should I follow?

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.

What should I do IF I FORGET to take a dose?

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.

Side Effects

What SIDE EFFECTS can this medicine cause?

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

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:

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).

Overdose

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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.

Storage

What should I know about STORAGE and DISPOSAL of this medication?

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).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Miscellaneous

What OTHER INFORMATION should I know?

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2016.