Ironwood Pharmaceuticals, Inc. has made a business-related decision to discontinue Duzallo.
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They are used together in patients with gout, when allopurinol alone has not worked well enough.
3 0 obj | LESINURAD (le SIN ure ad) and ALLOPURINOL (al oh PURE i nole) work together to reduce the amount of uric acid in the body. All material on this website is protected by copyright, Copyright © 1994-2020 by WebMD LLC. You may also have a fever, swollen glands, or joint pain. 2010 Indicated for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with allopurinol aloneUse 1 tablet of lesinurad/allopurinol equivalent to the total daily dose (TDD) of allopurinol; maintain TDD of allopurinol when initiating lesinurad/allopurinolLimitation of use: Not recommended for treatment of asymptomatic hyperuricemia1 tablet of lesinurad/allopurinol contains the maximum daily lesinurad dose (200 mg)Do not take more than 1 tablet of lesinurad/allopurinol per dayDo not combine lesinurad/allopurinol with additional lesinuradSerum creatinine elevation 1.5 x to <2.0 x baseline, lesinurad 400 mg/allopurinol (11%)Blood creatinine, lesinurad 400 mg/allopurinol (8%)Serum creatinine elevation ≥2.0 x baseline, lesinurad 400 mg/allopurinol (7%)Serum creatinine elevation 1.5 x to <2.0 x baseline, lesinurad 200 mg/allopurinol (4.4%)Blood creatinine elevation, lesinurad 200 mg/allopurinol (3.7%)Nephrolithiasis, lesinurad 400 mg/allopurinol (2.2%)Major adverse cardiovascular events (eg, cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), lesinurad 400 mg/allopurinol (1.85%)Serum creatinine elevation ≥2.0 x baseline, lesinurad 200 mg/allopurinol (1.5%)Major adverse cardiovascular events, lesinurad 200 mg/allopurinol (0.61%)Nephrolithiasis, lesinurad 200 mg/allopurinol (0.5%)Acute renal failure reported with lesinurad and more commonly occurs when administered as monotherapy; lesinurad should be used in combination with a xanthine oxidase inhibitor; adverse reactions related to renal function, including acute renal failure, reported after initiatingLesinurad 200 mg in combination with allopurinol associated with increased incidence of serum creatinine (Scr) elevations, mostly reversible Interrupt treatment if Scr increases to >2 times baseline; discontinue treatment if CrCl <45 mL/minInterrupt treatment and measure Scr promptly if symptoms of acute uric acid nephropathy (eg, flank pain, nausea or vomiting) occurDo not restart lesinurad/allopurinol unless an alternative cause of serum creatinine abnormalities is foundEvaluate renal function before treatment and periodically thereafter as clinically indicated; more frequent renal function monitoring recommended with CrCL < 60 mL/min or with Scr increases 1.5-2x baselineSevere renal impairment (CrCl <30 mL/min), end-stage renal disease, kidney transplant recipients, or patient on dialysisKnown hypersensitivity to allopurinol, including previous occurrence of skin rashIncrease risk of renal events; see Black Box WarningsFew cases reported of reversible clinical hepatoxicity with patients taking allopurinol; if anorexia, weight loss, or pruritus develops in patients on lesinurad/allopurinol, liver function should be evaluated; in patients with pre-existing liver disease, periodic liver function tests are recommendedIn clinical trials with lesinurad/allopurinol, major adverse cardiovascular events (eg, cardiovascular deaths, nonfatal myocardial infarctions, and nonfatal strokes) were observedOccasional occurrence of drowsiness was reported in patients taking allopurinol; caution when engaging in activities where alertness is mandatoryBone marrow depression has been reported in patients receiving allopurinol, most of whom received concomitant drugs with the potential for causing this reaction, ranging from 6 weeks to 6 years after initiating allopurinol therapy; see Drug interactions overviewNo available human data on use of lesinurad/allopurinol or lesinurad in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
Do not combine DUZALLO with ZURAMPIC® (lesinurad). Gout results from a build-up of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.
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