LES200 ALO300
tablet , film-coated , orange , oblong oblong
Debossed
for: Gout
Marketing Status: Discontinued
Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination for the treatment of hyperuricemia in patients with uncontrolled gout.
DUZALLO tablets have markings on one side, are plain on the reverse side and are available in the strengths and packages listed in Table 6.
Table 6: DUZALLO Tablet Presentations Tablet Strength
(Lesinurad/Allopurinol) Capsule-Shaped, Film-Coated, Tablet Tablet Markings Pack Size NDC Code
200/200 mg Light orange film-coated tablet Debossed with "LES200" above "ALO200" Bottle of 5 tablets
Bottle of 30 tablets
Bottle of 90 tablets 70785-021-05
70785-021-30
70785-021-90
200/300 mg Dark orange film-coated tablet Debossed with "LES200" above "ALO300" Bottle of 5 tablets
Bottle of 30 tablets
Bottle of 90 tablets 70785-022-05
70785-022-30
70785-022-90
16.2 Storage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
These highlights do not include all the information needed to use DUZALLO safely and effectively. See full prescribing information for DUZALLO.
DUZALLO® (lesinurad and allopurinol) tablets, for oral use
Initial U.S. Approval: 2017
WARNING: RISK OF ACUTE RENAL FAILURE
See full prescribing information for complete boxed warning
Acute renal failure has occurred with lesinurad, one of the components of DUZALLO. (5.1, 6.1)
INDICATIONS AND USAGE
DUZALLO, a combination of lesinurad, a URAT1 inhibitor, and allopurinol, a xanthine oxidase inhibitor, is indicated for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. (1)
Limitations of Use:
DUZALLO is not recommended for the treatment of asymptomatic hyperuricemia. (1.1)
DOSAGE AND ADMINISTRATION
The recommended dose of DUZALLO is one 200 mg lesinurad/300 mg allopurinol tablet per day (or one 200 mg lesinurad/200 mg allopurinol tablet per day for patients with renal impairment (45 - < 60 mL/min eCLcr) on a medically appropriate dose of 200 mg allopurinol (2.2)).
Use one tablet of DUZALLO in place of an equivalent portion of the total daily allopurinol dose. The total daily dose of allopurinol should be maintained at the time of initiating DUZALLO. (2.1)
One tablet of DUZALLO contains the maximum daily lesinurad dose (200 mg). (2.1)
Do not take more than 1 tablet of DUZALLO per day. (2.1)
Do not combine DUZALLO with ZURAMPIC® (lesinurad). (2.1)
Use of DUZALLO is not recommended for patients taking daily doses of allopurinol less than 300 mg (or less than 200 mg in patients with moderate renal impairment). (2.1)
DUZALLO tablets should be taken in the morning with food and water. (2.1)
Patients should be instructed to stay well hydrated. (2.1)
Assess renal function before initiating DUZALLO. Do not initiate DUZALLO if eCLcr is below 45 mL/min. (2.2)
Discontinue DUZALLO if eCLcr persistently falls below 45 mL/min. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets:
200 mg lesinurad/200 mg allopurinol (3)
200 mg lesinurad/300 mg allopurinol (3)
CONTRAINDICATIONS
Severe renal impairment, end-stage renal disease, kidney transplant recipients, or patients on dialysis (4, 8.6)
Tumor lysis syndrome or Lesch-Nyhan syndrome (4)
Known hypersensitivity to allopurinol, including previous occurrence of skin rash (5.2)
WARNINGS AND PRECAUTIONS
Renal events: Adverse reactions related to renal function, including acute renal failure, have occurred after initiating lesinurad, one of the components of DUZALLO. A higher incidence has occurred at the 400 mg dose of lesinurad than at the 200 mg dose. Monitor renal function at initiation and during therapy with DUZALLO, particularly in patients with eCLcr below 60 mL/min, and evaluate for signs and symptoms of acute uric acid nephropathy. (5.1)
Skin Rash and Hypersensitivity: DUZALLO, should be discontinued at the first appearance of skin rash or other signs that may indicate an allergic reaction, as allopurinol has been associated with severe hypersensitivity (some resulting in death). (5.2)
Hepatotoxicity: Hepatotoxicity has been reported in patients on allopurinol. Inform patients of warning signs and symptoms of hepatotoxicity. If symptoms develop, liver function evaluation should be performed. (5.3)
Cardiovascular events: Major adverse cardiovascular events were observed with lesinurad; a causal relationship has not been established. (5.4)
Bone Marrow Suppression: Bone marrow depression affecting one or more cell lines has been reported with allopurinol. (5.5)
ADVERSE REACTIONS
Most common adverse reactions in 12-month controlled clinical trials (occurring in greater than or equal to 2% of patients treated with lesinurad in combination with a xanthine oxidase inhibitor and more frequently than on xanthine oxidase inhibitor alone) were headache, influenza, blood creatinine increased, and gastroesophageal reflux disease. (6.1)
The most frequently reported adverse reaction for allopurinol is skin rash. (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Ironwood Pharmaceuticals, Inc. at 1-844-374-4793 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose to approximately one-third to one-fourth of the usual dose and closely monitor for therapeutic response and the appearance of toxicity. (5.5, 7.2)
Coumarin Anticoagulants: Carefully monitor prothrombin time. (5.6, 7.2)
Moderate Cytochrome P450 2C9 (CYP2C9) Inhibitors: Use DUZALLO with caution. (7.1)
CYP3A Substrates: Monitor for efficacy of the CYP3A substrate. (7.1)
USE IN SPECIFIC POPULATIONS
Renal impairment: Not recommended for patients with eCLcr below 45 mL/min. (2.2, 5.1, 8.6)
Hepatic impairment: Not recommended for patients with severe hepatic impairment. (8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2017
