Lesinurad

What is Lesinurad?

• Lesinurad (ZURAMPIC) is a URAT1 inhibitor used to treat high blood uric acid levels associated with gout.

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What are the uses of this medicine?

• This medicine is 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.

How does this medicine work?

• Lesinurad (le sin' ure ad) is a selective inhibitor of the uric acid transporter (URAT1) in the kidneys that is responsible for reabsorption or urate in the distal tubules.
• Inhibition of uric acid reabsorption causes a decrease in serum levels of uric acid, but an increase in urinary urate.
• Lesinurad was found to lower uric acid levels in patients with gout and hyperuricemia who had not achieved adequate control of symptoms or uric acid levels with a xanthine oxidase inhibitor (allopurinol or febuxostat) alone.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who 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)

What drug interactions can this medicine cause?

• ZURAMPIC should be used with caution in patients taking moderate inhibitors of CYP2C9 (eg, fluconazole, amiodarone), and in CYP2C9 poor metabolizers).
• 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.
• ZURAMPIC should not be administered with inhibitors of epoxide hydrolase(eg: valproic acid).
• Females should practice additional methods of contraception and not rely on hormonal contraception alone when taking ZURAMPIC.
• Aspirin at doses higher than 325 mg per day may decrease the efficacy of ZURAMPIC in combination with allopurinol.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage:

• ZURAMPIC is recommended at 200 mg once daily in combination with a xanthine oxidase inhibitor, including allopurinol or febuxostat. The maximum daily dose of ZURAMPIC is 200 mg
• Failure to take ZURAMPIC with a xanthine oxidase inhibitor may increase the risk of renal adverse reactions.

Patients with Renal Impairment

• No dose adjustment is needed in patients with mild or moderate renal impairment (eCLcr of 45 mL/min or greater).
• ZURAMPIC should not be initiated in patients with an eCLcr less than 45 mL/min.
• Assessment of renal function is recommended prior to initiation of ZURAMPIC therapy and periodically thereafter.
• ZURAMPIC should be discontinued when eCLcr is persistently less than 45 mL/min.

Administration

• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablet: 200 mg

This medicine is available in fallowing brand namesː

• ZURAMPIC

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• flu
• higher levels of blood creatinine (a measure of kidney function)
• heart burn (acid reflux)

ZURAMPIC may cause serious side effects, including:

• kidney problems
• Heart problems

What special precautions should I follow?

• 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.
• Adverse reactions related to renal function have occurred after initiating ZURAMPIC. A higher incidence was observed at the 400 mg dose, with the highest incidence occurring with monotherapy use. Monitor renal function at initiation and during therapy with ZURAMPIC, particularly in patients with eCLcr below 60 mL/min, and evaluate for signs and symptoms of acute uric acid nephropathy.
• Major adverse cardiovascular events were observed with ZURAMPIC; a causal relationship has not been established.

What to do in case of emergency/overdose?

Management of overdosage:

• In case of overdose patients should be managed by symptomatic and supportive care including adequate hydration.

Can this medicine be used in pregnancy?

• There are no available human data on use of ZURAMPIC in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lesinurad
• Inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, crospovidone, and magnesium stearate.

Who manufactures and distributes this medicine?

• Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington
• Manufactured by: AstraZeneca AB, S-151 85 Sodertalje, Sweden; Product of Ireland

ZURAMPIC is a trademark of the AstraZeneca group of companies.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Lesinurad
• FDA Lesinurad

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