When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you have tumor lysis syndrome or Lesch-Nyhan syndrome.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine with food and water in the morning and together with another medicine your doctor will prescribe (a xanthine oxidase inhibitor).
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Drink extra fluids so you will urinate more often and help prevent kidney problems. Drink at least 2 liters (68 ounces) of extra fluid each day.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines may affect how lesinurad works. Tell your doctor if you are using any of the following:
  
  • Amiodarone, amlodipine, aspirin, carbamazepine, fluconazole, rifampin, sildenafil, valproic acid
  • Birth control pills, patches, or injections
  • Statin medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, or a history of a heart attack or stroke.
• This medicine may cause the following problems:
  
  • Kidney problems
  • Heart or blood vessel problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating, faintness
• Decrease in how much or how often you urinate, rapid weight gain, swelling of the face, ankles, or hands
• Nausea, vomiting, severe pain in your side

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088