Zurampic

Serious side effects have been reported with Zurampic including the following: 

• Heart problems. People who take Zurampic can have serious heart problems including heart attack and stroke.
• Kidney problems. Your doctor will monitor your kidney function before starting Zurampic and monitor during your treatment. 

Make sure to take Zurampic with xanthine oxidase inhibitor such as allopurinol or febuxostat. Zurampic should not be taken alone. Taking Zurampic alone can hurt your kidneys. 

Make sure to remain hydrated and avoid becoming dehydrated. It is recommended you drink 2 liters (68 ounces) of fluid each day to stay hydrated. 

Do not take Zurampic if you:

• are allergic to Zurampic or to any of its ingredients (include for all meds)
• have severe kidney problems, received a kidney transplant or you are on dialysis
• have a fast breakdown of cancer cells that can lead to high uric acid (Tumor lysis syndrome)
• have a rare inherited condition that causes too much uric acid in the blood (Lesch Nyhan syndrome)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zurampic, there are no specific foods that you must exclude from your diet when receiving this medication.

WARNING: RISK OF ACUTE RENAL FAILURE, MORE COMMON WHEN USED WITHOUT A XANTHINE OXIDASE INHIBITOR

Acute renal failure has occurred with Zurampic and was more common when Zurampic was given alone. Zurampic should be used in combination with a xanthine oxidase inhibitor.

Lesinurad can cause kidney failure, especially if you take it without your other prescribed medications. Call your doctor right away if you urinate less than usual or not at all, if you have pain when urinating, swelling in your feet or ankles, or shortness of breath.

Skip the missed dose if morning has already passed. Do not take lesinurad later in the day. Wait until the next day to take your next scheduled dose. Do not take extra medicine to make up the missed dose.

Lesinurad is used together with a xanthine oxidase inhibitor (eg, allopurinol, febuxostat) to treat gout. It works to lower uric acid levels in the blood.

This medicine is available only with your doctor's prescription.

• It is used to lower uric acid in the blood.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Zurampic or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zurampic. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

CYP2C9 Inhibitors, CYP2C9 Poor Metabolizers, and CYP2C9 Inducers

Lesinurad exposure is increased when Zurampic is co-administered with inhibitors of CYP2C9, and in CYP2C9 poor metabolizers. Zurampic should be used with caution in patients taking moderate inhibitors of CYP2C9 (eg, fluconazole, amiodarone), and in CYP2C9 poor metabolizers [see Clinical Pharmacology (12.3)].

Lesinurad exposure is decreased when Zurampic is co-administered with moderate inducers of CYP2C9 (eg, rifampin, carbamazepine), which may decrease the therapeutic effect of Zurampic [see Clinical Pharmacology (12.3)].

CYP3A Substrates

In interaction studies conducted in healthy subjects with Zurampic and CYP3A substrates, lesinurad reduced the plasma concentrations of sildenafil and amlodipine [see Clinical Pharmacology (12.3)]. Although there was not a clinically significant interaction with atorvastatin, HMG-CoA reductase inhibitors that are sensitive CYP3A substrates may be affected. The possibility of reduced efficacy of concomitant drugs that are CYP3A substrates should be considered and their efficacy (eg, blood pressure and cholesterol levels) should be monitored.

Epoxide Hydrolase Inhibitors

In vitro studies suggest that lesinurad is not an inhibitor of epoxide hydrolase; however, inhibitors of epoxide hydrolase (ie, valproic acid) may interfere with metabolism of lesinurad. Zurampic should not be administered with inhibitors of epoxide hydrolase.

Hormonal Contraceptives

Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when Zurampic is co-administered. Females should practice additional methods of contraception and not rely on hormonal contraception alone when taking Zurampic.

Aspirin

Aspirin at doses higher than 325 mg per day may decrease the efficacy of Zurampic in combination with allopurinol. Aspirin at doses of 325 mg or less per day (ie, for cardiovascular protection) does not decrease the efficacy of Zurampic and can be coadministered with Zurampic.

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

Administration

Advise patients:

• To take Zurampic in the morning with food and water at the same time as a xanthine oxidase inhibitor, allopurinol, or febuxostat.
• Not to take Zurampic alone and to discontinue Zurampic if treatment with the xanthine oxidase inhibitor medication is discontinued.
• Not to take a missed dose of Zurampic later in the day, to wait to take Zurampic on the next day, and not to double the dose.
• To stay well hydrated (eg, 2 liters [68 oz] 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 Zurampic. Advise patients that periodic monitoring of blood creatinine levels are recommended [see Warnings and Precautions (5.1)].

Gout Flares

Inform patients that gout flares may occur after initiation of Zurampic and of the importance of taking gout flare prophylaxis medication to help prevent gout flares. Advise patients not to discontinue Zurampic if a gout flare occurs during treatment [see Dosage and Administration (2.3)].

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

By: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Zurampic is a trademark of the AstraZeneca group of companies.

© AstraZeneca 2017

Zurampic (lesinurad) helps the kidneys remove uric acid from the body. Lesinurad is used together with other medicines that can cause the body to produce less uric acid.

Zurampic is used as part of a combination of medicines to treat high levels of uric acid in your blood, also called hyperuricemia. High levels of uric acid can lead to a condition called gout.

Zurampic should be used together with allopurinol (Zyloprim) or febuxostat (Uloric). It should not be used alone.

Zurampic can cause kidney failure, especially if you take it without your other prescribed medications. Call your doctor right away if you urinate less than usual or not at all, if you have pain when urinating, swelling in your feet or ankles, or shortness of breath.

Common side effects of Zurampic include: increased serum creatinine. Other side effects include: acute renal failure. See below for a comprehensive list of adverse effects.

Applies to lesinurad: oral tablet

Along with its needed effects, lesinurad (the active ingredient contained in Zurampic) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lesinurad:

• Agitation
• chest pain or discomfort
• confusion
• decreased urine output
• depression
• difficulty with speaking
• dizziness
• double vision
• headache
• hostility
• inability to move the arms, legs, or facial muscles
• inability to speak
• irritability
• lethargy
• muscle twitching
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• rapid weight gain
• seizures
• shortness of breath
• slow speech
• sweating
• swelling of the face, ankles, or hands
• unusual tiredness or weakness
• vomiting

Some side effects of lesinurad may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle aches and pains
• runny nose
• shivering
• sore throat
• trouble sleeping

• Heartburn