ZURAMPIC- lesinurad tablet, film coated 
Ironwood Pharmaceuticals, Inc.

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This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised:January 2018
MEDICATION GUIDE
ZURAMPIC (zer-AM-pik)
(lesinurad)
tablets
What is the most important information I should know about ZURAMPIC?
Some patients taking ZURAMPIC may have kidney problems such as a sudden decrease in kidney function (acute kidney failure). This is more common when you take ZURAMPIC without a xanthine oxidase inhibitor. You should always take ZURAMPIC with a xanthine oxidase inhibitor.
What is ZURAMPIC?
  • ZURAMPIC is a prescription medicine used together with a xanthine oxidase inhibitor to lower uric acid levels in the blood in adult patients with gout.
  • ZURAMPIC should not be taken without a xanthine oxidase inhibitor such as allopurinol or febuxostat.
  • ZURAMPIC helps the kidneys remove uric acid from the body and is added to a xanthine oxidase inhibitor, which decreases the amount of uric acid your body makes.
  • It is not known if ZURAMPIC is safe and effective in children under 18 years of age.
Who should not take ZURAMPIC?
Do not take ZURAMPIC if you have:
  • severe kidney problems, received a kidney transplant or you are on dialysis
  • a fast breakdown of cancer cells that can lead to high uric acid (Tumor lysis syndrome)
  • a rare inherited condition that causes too much uric acid in the blood (Lesch Nyhan syndrome)
Before taking ZURAMPIC, tell your healthcare provider about all of your medical conditions, including if you:
  • are pregnant or plan to become pregnant. It is not known if ZURAMPIC will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ZURAMPIC passes into your breast milk. You and your healthcare provider should decide if you should take ZURAMPIC while breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ZURAMPIC may affect the way other medicines work, and other medicines may affect how ZURAMPIC works.
Especially tell your healthcare provider if you take:
  • medicine for heart problems or high blood pressure
  • medicine for high blood cholesterol
  • antifungals and antibiotics
  • valproic acid
  • aspirin
  • other medicines for gout
  • hormonal contraceptives. Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should use a back-up method of birth control during treatment with ZURAMPIC.
Ask your healthcare provider or pharmacist if you are not sure if you take any of these medicines.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ZURAMPIC?
  • Take ZURAMPIC exactly as your healthcare provider tells you to take it.
  • Take 1 ZURAMPIC tablet in the morning with your dose of xanthine oxidase inhibitor such as allopurinol or febuxostat. Do not take more than 1 ZURAMPIC tablet each day.
  • Take ZURAMPIC with food and water.
  • Drink 2 liters (68 ounces) of fluid each day to stay hydrated.
  • If you miss taking the dose of ZURAMPIC in the morning, do not take ZURAMPIC later in the day. Wait and take your next dose of ZURAMPIC in the morning with your dose of xanthine oxidase inhibitor such as allopurinol or febuxostat. Do not double your dose of ZURAMPIC.
  • Your gout may get worse (flare up) when you first start taking ZURAMPIC. Do not stop taking ZURAMPIC 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 blood tests to check how well your kidneys are working before and during your treatment with ZURAMPIC.
What should I avoid while taking ZURAMPIC?
  • Avoid taking ZURAMPIC alone. This could increase your risk of kidney problems. ZURAMPIC should always be taken together with a xanthine oxidase inhibitor such as allopurinol or febuxostat.
  • Avoid becoming dehydrated while taking ZURAMPIC.
What are the possible side effects of ZURAMPIC?
ZURAMPIC may cause serious side effects, including:
The most common side effects of ZURAMPIC include:
  • headache
  • flu
  • higher levels of blood creatinine (a measure of kidney function)
  • heart burn (acid reflux)
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 ZURAMPIC. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZURAMPIC?
  • Store ZURAMPIC at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep ZURAMPIC away from light.
Keep ZURAMPIC and all medicines out of the reach of children.
General Information about the safe and effective use of ZURAMPIC.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZURAMPIC for a condition for which it was not prescribed. Do not give ZURAMPIC to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about ZURAMPIC. If you would like more information about ZURAMPIC, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZURAMPIC that is written for healthcare professionals.
What are the ingredients in ZURAMPIC?
Active ingredient:
lesinurad
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, crospovidone, and magnesium stearate.
Manufactured for: Ironwood Pharmaceuticals, Inc., Cambridge, MA 02142
Manufactured by: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Ironwood and the three-leaf design are registered trademarks of Ironwood Pharmaceuticals, Inc.
ZURAMPIC is a trademark of the AstraZeneca group of companies.
© AstraZeneca and Ironwood Pharmaceuticals, Inc. 2018
For more information, go to www. ZURAMPIC.com or call 1-844-374-4793.
Revised: 12/2018
Ironwood Pharmaceuticals, Inc.