Urece (Dotinurad): Highly Selective URAT1 Inhibitor for Gout and Hyperuricemia

　　Drug Overview

　　Urece(generic name:dotinurad,brand name:Urece)is a highly selective urate transporter 1(URAT1)inhibitor developed by Fuji Yakuhin Co.,Ltd.,Japan.It was first approved in Japan in 2020 for the treatment of adult patients with gout and hyperuricemiaEisai Co.,Ltd..The drug specifically inhibits the URAT1 transporter responsible for uric acid reabsorption in the renal proximal tubules,significantly increasing urinary uric acid excretion and effectively lowering serum uric acid levels.Compared with traditional uricosuric agents,dotinurad has high selectivity for URAT1 with minimal effects on other uric acid transporters,resulting in better safety and tolerability.

　　Indications

　　Urece is indicated for the treatment of adult patients with gout and hyperuricemia.

　　Dosage and Administration

　　Starting and Maintenance Doses

　　This product is for oral administration once daily,preferably at the same time each day.

　　Starting dose:0.5 mg orally once daily for adults.

　　Dose adjustment:After at least 2 weeks of initial treatment,the dose may be increased to 1 mg daily based on serum uric acid levels.After an additional 6 weeks or more of treatment,it may be further increased to 2 mg daily as the usual maintenance dose.

　　Maximum dose:Do not exceed 4 mg daily.All dose adjustments should be individualized based on the patient's serum uric acid levels and overall health status.

　　Precautions

　　Management of Gout Flares

　　Patients with active acute gouty arthritis should wait until symptoms have completely resolved before initiating urate-lowering therapy.If a gout flare occurs during treatment,Urece does not need to be discontinued.Continue the original dose and concomitantly use colchicine,nonsteroidal anti-inflammatory drugs,or corticosteroids to control acute symptoms.

　　Prevention of Urolithiasis

　　During the initial phase of treatment,significantly increased urinary uric acid excretion may increase the risk of urinary stone formation.Patients should be encouraged to drink plenty of fluids throughout treatment to maintain a daily urine output of at least 2000 ml.Urine alkalinization may be considered if necessary to prevent complications such as urolithiasis,hematuria,and renal colic.

　　Liver Function Monitoring

　　Although clinical studies have shown no clinically significant effect of dotinurad on liver function,regular monitoring of liver function parameters is recommended during treatment,especially during the first 3 months,given reports of severe liver injury with other uricosuric agents.

　　Renal Considerations

　　No dosage adjustment is required for patients with mild to moderate renal impairment(eGFR≥30 mL/min/1.73m²).The efficacy of Urece may be significantly reduced in patients with severe renal impairment(eGFR<30 mL/min/1.73m²),and it should be avoided in patients with oliguria or anuria.

　　Drug Interactions

　　Caution is advised when Urece is used concomitantly with the following medications:

　　Pyrazinamide:Its metabolite promotes URAT1-mediated uric acid reabsorption,which may antagonize the urate-lowering effect of Urece.

　　Salicylates:High-dose salicylates inhibit uric acid excretion and may diminish the efficacy of Urece.

　　Contraindications

　　Hypersensitivity to dotinurad or any excipient of this product.

　　Severe renal impairment(eGFR<30 mL/min/1.73m²).

　　Active urinary tract stones,unless no other suitable treatment options are available.