Lesinurad tablets

What is this medication?

LESINURAD (le SIN ure ad) reduces uric acid levels in the blood. It is used together with a xanthine oxidase inhibitor such as allopurinol or febuxostat to treat the symptoms of gout.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZURAMPIC

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• an inherited condition that causes too much uric acid in the blood (Lesch Nyhan syndrome)
• cancer
• dehydration
• have received a kidney transplant
• kidney disease
• liver disease
• on dialysis
• an unusual or allergic reaction to lesinurad, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Do not take this medicine alone. Take this medicine in the morning with your dose of xanthine oxidase inhibitor such as allopurinol or febuxostat. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss your dose in the morning, do not take it later in the day. Wait and take your next dose the following morning. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• aspirin
• certain antibiotics like rifampin
• certain medicines for blood pressure, heart disease, irregular heart beat like amiodarone, amlodipine
• certain medicines for cholesterol like atorvastatin
• certain medicines for fungal infections, like fluconazole
• certain medicines for seizures like carbamazepine, valproic acid
• female hormones, like estrogens and progestins and birth control pills, patches, rings, or injections
• sildenafil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse. Your gout may get worse (flare up) when you first start this medicine. Do not stop taking this medicine even if you have a flare. Your doctor or health care professional may give you other medicines to help prevent your gout flares.

Do not take this medicine alone. This medicine should always be taken together with a xanthine oxidase inhibitor such as allopurinol or febuxostat.

Drink 2 liters (68 ounces) of fluid each day to stay hydrated. Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot.

You may need blood work done while you are taking this medicine.

Birth control pills, injections, patches, or implants may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• signs and symptoms of a heart attack like breathing problems; chest pain or discomfort; feeling faint or lightheaded, falls; nausea, vomiting; back or jaw pain
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine, flank pain
• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm, or leg; trouble walking; dizziness; loss of balance or coordination

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• general ill feeling or flu-like symptoms
• headache
• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.