Lesinurad, Oral

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KEY POINTS

• This medicine is taken by mouth, along with another medicine, to treat high levels of uric acid in the blood when other medicines have not worked. This medicine should NOT be taken alone.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe kidney problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antigout; URAT1 inhibitor

Generic and brand names: lesinurad, oral; Zurampic

What is this medicine used for?

This medicine is taken by mouth, along with another medicine, to treat high levels of uric acid in the blood when other medicines have not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke
• Heart disease or a heart attack
• Kidney disease, dialysis, or a kidney transplant
• Lesch-Nyhan syndrome (an inherited disease)
• Liver disease
• Tumor lysis syndrome (a fast breakdown of cancer cells)

You have a greater risk of having an allergic reaction to this medicine if you have kidney problems or are taking a thiazide diuretic (water pill), an ACE inhibitor, or an antibiotic such as amoxicillin or ampicillin. Talk to your healthcare provider about this.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as prescribed. This medicine will not stop a gout attack that is already underway. However, when taken for several months, this medicine will reduce your symptoms. Keep taking it regularly. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with other medicines your healthcare provider prescribes. This medicine must be taken along with a xanthine oxidase inhibitor such as allopurinol. Ask your healthcare provider if you have any questions.

Take this medicine in the morning with food and water to lessen the chance the medicine will upset your stomach. Drink 8 to 10 glasses of liquid daily while you are taking this medicine, unless your healthcare provider directs you otherwise. Talk to your provider about how much liquid you should drink if you have kidney or heart problems.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure about what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

This medicine may cause severe kidney problems or kidney failure. Contact your healthcare provider right away if you have trouble urinating, a change in how much you urinate, or blood in your urine.

People who take this medicine may have serious heart problems, including heart attack or stroke. It is not known if this medicine causes these problems. Talk with your healthcare provider about this.

This medicine may increase your risk of a gout attack when you first start taking it. Your healthcare provider may prescribe other medicines to prevent gout attacks. Talk to your healthcare provider about this.

You may need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, or peeling skin; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Chest pain, trouble urinating, decreased urination, blood in urine, unexplained swelling, lower back or side pain, severe nausea or vomiting.

Other: Heartburn, headache, muscle aches.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as rifampin (Rifadin), rifapentine (Priftin), sulfadiazine, and sulfamethoxazole/trimethoprim (Bactrim, Septra)
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend)
• Aspirin (more than 325 mg/day)
• Cancer medicines such as abiraterone (Zytiga), capecitabine (Xeloda), ceritinib (Zykadia), floxuridine, fluorouracil (Adrucil, Carac, Efudex, Fluoroplex), and sorafenib (Nexavar)
• Cholesterol-lowering medicines such as fluvastatin (Lescol) and gemfibrozil (Lopid)
• Elbasvir/grazoprevir (Zepatier)
• Heart medicines such as amiodarone (Cordarone, Pacerone), irbesartan (Avapro), losartan (Cozaar), and nicardipine (Cardene)
• HIV medicines such as delavirdine (Rescriptor), efavirenz (Sustiva), and etravirine (Intelence)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Leflunomide (Arava)
• Malaria medicines such as pyrimethamine (Daraprim) and quinine
• Milk thistle
• Omeprazole (Prilosec)
• Ticagrelor (Brilinta)
• Tolbutamide
• Zafirlukast (Accolate)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.