Classes
DEA Class; Rx
Common Brand Names; Duzallo (DSC)
- Selective Uric acid Reabsorption Inhibitor (SURI);
- Xanthine Derivatives;
- Antigout Agents
Description
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
Indications
Indicated for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with allopurinol alone
Contraindications
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
Adverse Effects
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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
Lesinurad 200 mg/day PO; allopurinol 300 mg/day PO.
Lesinurad 200 mg/day PO; allopurinol 300 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
allopurinol/lesinurad
April 2019: Product discontinued by manufacturer
tablet
- 200 mg/200 mg
- 200 mg/300 mg