Zurampic (lesinurad) Gets FDA Approval For Gout Caused By High Uric Acid | Omudhome Ogbru, PharmD | RxEconsult

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Zurampic (lesinurad) From AstraZeneca Gets FDA Approval For Gout Caused By High Uric Acid Category: Rheumatoid Arthritis & Inflammatory Conditions by - December 24, 2015 | Views: 30924 | Likes: 1 | Comment: 1  

Zurampic is a selective uric acid reabsorption inhibitor (SURI) that is used in combination with a xanthine oxidase inhibitor (allopurinol or febuxostat) for chronic treatment of gout. It works in the kidney and increases uric acid excretion. It does this by blocking the action of transporter proteins (URAT1) that cause uric acid reabsorption in the kidney.

The safety and efficacy of Zurampic were evaluated in 3 clinical trials that enrolled 1,537 patients who were treated for up to 12 months. Zurampic 200 mg once daily in combination with allopurinol or febuxostat was compared against allopurinol or febuxostat alone. Zurampic plus a xanthine inhibitor was significantly better than a xanthine oxidase inhibitor alone in reducing serum uric levels and getting patients to target serum uric acid levels of <6.0mg/dL (360 µmol/L) by month 6. 

The most common adverse reactions in clinical trials were a headache, influenza, increased blood creatinine, and gastroesophageal reflux disease. Zurampic has a boxed warning about the risk for acute kidney failure which is more common at higher doses and when Zurampic is used without a xanthine inhibitor. Kidney function should be evaluated at initiation and during therapy, especially in patients with creatinine clearance below 60 mL/min. Patients should also be evaluated for signs and symptoms of acute uric acid kidney damage. Major adverse events related to the heart and circulatory system were observed during treatment with Zurampic and the FDA has requested a postmarketing study to evaluate the effects of Zurampic on the kidney, heart, and circulatory system.

Zurampic is supplied as 200 mg tablets and the recommended dose is  200 mg once daily in combination with allopurinol (Zyloprim) or febuxostat (Uloric). The maximum dose of Zurampic is 200 mg once daily.


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