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DUZALLO- lesinurad and allopurinol tablet, film coated


  1. Patient Information
  2. Advise Patients:
  3. Duzallo Can Cause Serious Side Effects, Including:
  4. How Should I Take Duzallo?
  5. What Should I Avoid While Taking Duzallo?
  6. What Are The Possible Side Effects Of Duzallo?
  7. What Are The Ingredients In Duzallo?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration

Advise Patients: 

  • To take one tablet of DUZALLO in the morning with food and water.
  • Not to take a missed dose of DUZALLO later in the day, but to wait to take DUZALLO on the next day, and not to double the dose.
  • Not to take DUZALLO with ZURAMPIC (lesinurad).
  • To stay well hydrated (e.g., 2 liters of liquid per day).

Renal Events

Inform patients that renal events including transient increases in blood creatinine level and acute renal failure have occurred in some patients who take DUZALLO. Advise patients that periodic monitoring of blood creatinine levels is recommended [

Duzallo Can Cause Serious Side Effects, Including: 

  • Kidney problems. Some people taking DUZALLO may have kidney problems such as a sudden decrease in kidney function (acute kidney failure). Your healthcare provider may do blood tests to check your kidneys while you are taking DUZALLO.
  • Serious skin rash and serious allergic reactions. Severe and potentially life-threatening allergic reactions and skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported in some people taking allopurinol, one of the components of DUZALLO.Stop taking DUZALLO and get emergency medical help if you have any of the following symptoms:
  • skin rash; blistering of the skin, mouth, nose, and genitals
  • painful red or purple skin that looks burned and peels off
  • joint pain; swollen glands
  • red, painful, watery eyes; persistent itching; hives
  • fever

  • DUZALLO is a prescription medicine that contains 2 medicines, a URAT1 inhibitor called lesinurad and a xanthine oxidase inhibitor called allopurinol.
  • DUZALLO is used to lower uric acid levels in the blood in people with gout, when allopurinol alone has not worked well enough.

It is not known if DUZALLO is safe and effective in children under 18 years of age.

Do not take DUZALLO 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)
  • had a skin rash or other allergic reaction after taking allopurinol

Before taking DUZALLO, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney or liver problems.
  • are pregnant or plan to become pregnant. It is not known if DUZALLO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Allopurinol can pass into your breast milk.Talk to your healthcare provider about the best way to feed your baby if you take DUZALLO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. DUZALLO may affect the way other medicines work, and other medicines may affect how DUZALLO works.

Especially tell your healthcare provider if you take:

  • certain medicines that lower your immune system including mercaptopurine and azathioprine
  • blood thinner medicines
  • medicines for heart conditions or high blood pressure
  • medicines 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 DUZALLO.

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 or pharmacist when you get a new medicine.

How Should I Take Duzallo? 

  • Take DUZALLO exactly as your healthcare provider tells you to take it.
  • Take 1 DUZALLO tablet each day in the morning. Do not take more than 1 DUZALLO tablet each day.
  • Do nottake DUZALLO with ZURAMPIC(lesinurad).
  • Take DUZALLO with food and water.
  • Drink 2 liters (68 ounces) of fluid each day to stay hydrated.
  • If you miss a dose of DUZALLO in the morning, do not take DUZALLO later in the day. Wait and take your next dose of 1 DUZALLO tablet the next morning. Do not double your dose of DUZALLO.
  • Your gout may get worse (flare up) when you first start taking DUZALLO. Do not stop taking DUZALLO even if you have a flare up. Your healthcare provider may give you other medicines to help prevent your gout flare ups.

What Should I Avoid While Taking Duzallo? 

  • Avoid becoming dehydrated while taking DUZALLO.
  • DUZALLO can cause you to be drowsy. Do not drive, use machinery, or do other dangerous activities until you know how DUZALLO affects you.

What Are The Possible Side Effects Of Duzallo? 

DUZALLO may cause serious side effects including:

    • Store DUZALLO at room temperature between 68 F and 77 F (20 C to 25 C).

    Keep DUZALLO and all medicines out of the reach of children.

    General Information about the safe and effective use of DUZALLO.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DUZALLO for a condition for which it was not prescribed. Do not give DUZALLO to other people, even if they have the same symptoms that you have. It may harm them.

    You can ask your pharmacist or healthcare provider for information about DUZALLO that is written for health professionals.

What Are The Ingredients In Duzallo? 

Active ingredients: lesinurad and allopurinol

Inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triacetin. DUZALLO 200/200 mg tablets are coated with Opadry orange and DUZALLO 200/300 mg tablets are coated with Opadry beige.

Manufactured for: Ironwood Pharmaceuticals, Inc., Cambridge, MA 02142

By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden.

Ironwood and the three-leaf design are registered trademarks of Ironwood Pharmaceuticals, Inc.

DUZALLO and ZURAMPIC are registered trademarks of the AstraZeneca group of companies.

AstraZeneca and Ironwood Pharmaceuticals, Inc. 2017

For more information, go to www.DUZALLO.com or call 1-844-374-4793.



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