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Lesinurad/Allopurinol

    Discontinued

    DEA Class; Rx

    Common Brand Names; Duzallo (DSC)

    • Selective Uric acid Reabsorption Inhibitor (SURI); 
    • Xanthine Derivatives; 
    • Antigout Agents

    Combination of a uricosuric agent that is an urate transporter (URAT1) inhibitor with allopurinol, a xanthine oxidase inhibitor
    Used for patients who have not achieved target serum uric acid levels with optimized allopurinol therapy alone
    Boxed warning regarding a risk of renal failure; do not use in patients with CrCl less than 45 mL/minute

    Indicated for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with allopurinol alone

    Severe renal impairment (CrCl <30 mL/min), end-stage renal disease, kidney transplant recipients, or patient on dialysis

    Tumor lysis syndrome or Lesch-Nyhan syndrome

    Known hypersensitivity to allopurinol, including previous occurrence of skin rash

    Serum 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%)

    Influenza, lesinurad 200 mg/allopurinol (4.9%)

    Serum creatinine elevation 1.5 x to <2.0 x baseline, lesinurad 200 mg/allopurinol (4.4%)

    Headache, lesinurad 200 mg/allopurinol (4.2%)

    Blood creatinine elevation, lesinurad 200 mg/allopurinol (3.7%)

    Renal failure, lesinurad 400 mg/allopurinol (3.5%)

    Gastroesophageal reflux disease (3.2%)

    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%)

    Renal failure, lesinurad 200 mg/allopurinol (1%)

    Few 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 recommended

    In clinical trials with lesinurad/allopurinol, major adverse cardiovascular events (eg, cardiovascular deaths, nonfatal myocardial infarctions, and nonfatal strokes) were observed

    Occasional occurrence of drowsiness was reported in patients taking allopurinol; caution when engaging in activities where alertness is mandatory

    Bone 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 overview

    No available human data on use of lesinurad/allopurinol or lesinurad in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse development outcomes

    Adults

    Lesinurad 200 mg/day PO; allopurinol 300 mg/day PO.

    Geriatric

    Lesinurad 200 mg/day PO; allopurinol 300 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    allopurinol/lesinurad

    April 2019: Product discontinued by manufacturer

    tablet

    • 200 mg/200 mg
    • 200 mg/300 mg