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Duzallo

Last reviewed on RxList: 6/7/2018
Duzallo Side Effects Center

Last reviewed on RxList 6/7/2018

Duzallo (lesinurad and allopurinol) is a combination of a URAT1 inhibitor and a xanthine oxidase inhibitor 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. Common side effects of Duzallo include:

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 to less than 60 mL/min eCLcr) on a medically appropriate dose of 200 mg allopurinol. 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. Duzallo may interact with:

Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Duzallo; it is unknown how it would affect a fetus. It is unknown if Duzallo passes into breast milk. Consult your doctor before breastfeeding.

Our Duzallo (lesinurad and allopurinol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Gout is a form of arthritis. See Answer
Duzallo Professional Information

SIDE EFFECTS

The following adverse reactions are also discussed in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Lesinurad In Combination With Allopurinol

In 2 randomized, placebo-controlled studies (Studies 1 and 2), a total of 405, 401, and 407 patients with gout were treated with lesinurad 200 mg, lesinurad 400 mg, or placebo, respectively, once daily in combination with allopurinol (200 mg to 900 mg daily) for up to 12 months. The majority of patients in these studies received allopurinol daily doses of 200 mg or 300 mg (average dose of allopurinol in the studies was 310 mg), corresponding to the allopurinol doses contained in DUZALLO. The median duration of treatment with lesinurad in combination with allopurinol was 11.2 months. The mean age of the population was 52 years (range 18-82), and 95% were males. At baseline, 61% of the patient population showed mild or moderate renal impairment (eCLcr less than 90 mL/min) and 81% of patients had at least one co-morbid condition including hypertension (66%), hyperlipidemia (46%), diabetes (17%), and kidney stones (12%).

Renal Events

Lesinurad causes an increase in renal uric acid excretion, which may lead to renal events including transient increases in serum creatinine, renal-related adverse reactions, and kidney stones. These renal events occurred more frequently in patients receiving lesinurad 400 mg than in patients receiving 200 mg [see WARNINGS AND PRECAUTIONS].

The number of patients with serum creatinine elevations in the 12-month placebo-controlled trials in combination with allopurinol is shown in Table 1. Most of these elevations on lesinurad 200 mg in combination with allopurinol and lesinurad 400 mg in combination with allopurinol resolved without treatment interruption (Table 1).

Table 1: Patients With Elevated Serum Creatinine Values in the Placebo-Controlled Clinical Studies With Lesinurad in Combination With Allopurinol

[n (%)] Placebo + Allopurinol
(N=407)
Lesinurad 200 mg + Allopurinol
(N=405)
Lesinurad 400 mg + Allopurinol
(N=401)
Serum creatinine elevation 1.5 x to < 2.0 x baseline 9 (2.2%) 18 (4.4%) 44 (11.0%)
  Resolution of serum creatinine elevations by end of study 6/9 (66.7%) 16/18 (88.9%) 35/44 (79.5%)
Serum creatinine elevation ≥ 2.0 x baseline 0 6 (1.5%) 28 (7.0%)
  Resolution of serum creatinine elevations by end of study N/A 6/6 (100.0%) 21/28 (75.0%)

Renal-related adverse reactions, including blood creatinine increased and renal failure, and nephrolithiasis reported in patients receiving lesinurad 200 mg, lesinurad 400 mg, and placebo in combination with allopurinol are shown in Table 2 [see WARNINGS AND PRECAUTIONS]. The incidence of reports of “blood creatinine increased” was higher with lesinurad in combination with allopurinol and was highest with lesinurad 400 mg in combination with allopurinol. Renal-related adverse reactions by baseline renal function category are shown in Table 3 [see WARNINGS AND PRECAUTIONS]. Blood creatinine increased occurred more frequently in patients treated with lesinurad 400 mg in combination with allopurinol across baseline renal function categories (Table 3).

Table 2: Incidence of Renal-Related Adverse Reactions and Nephrolithiasis in Placebo-Controlled Clinical Studies With Lesinurad in Combination With Allopurinol

n (%) Placebo + Allopurinol
(N=407)
Lesinurad 200 mg + Allopurinol
(N=405)
Lesinurad 400 mg + Allopurinol
(N=401)
Blood creatinine increased 9 (2.2%) 15 (3.7%) 32 (8.0%)
Renal failure1 7 (1.7%) 4 (1.0%) 14 (3.5%)
Nephrolithiasis 5 (1.2%) 2 (0.5%) 9 (2.2%)
1 Renal failure includes the following adverse reactions: renal failure, renal impairment, renal failure chronic, renal failure acute, acute prerenal failure.

Table 3: Incidence of Renal-Related Adverse Reactions by Baseline Renal Function Category in Placebo-Controlled Clinical Studies With Lesinurad in Combination With Allopurinol

n (%) Placebo + Allopurinol Lesinurad 200 mg + Allopurinol Lesinurad 400 mg + Allopurinol
≥ 90 mL/min n=149 n=163 n=161
  Blood creatinine increased 0 5 (3.1%) 6 (3.7%)
  Renal failure1 0 2 (1.2%) 6 (3.7%)
≥ 60 -< 90 mL/min n=176 n=167 n=168
  Blood creatinine increased 3 (1.7%) 5 (3.0%) 17 (10.1%)
  Renal failure1 4 (2.3%) 1 (0.6%) 6 (3.6%)
≥ 30 -< 60 mL/min n=78 n=73 n=70
  Blood creatinine increased 6 (7.7%) 4 (5.5%) 8 (11.4%)
  Renal failure1 3 (3.8%) 1 (1.4%) 2 (2.9%)
1 Renal failure includes the following adverse reactions: renal failure, renal impairment, renal failure chronic, renal failure acute, acute prerenal failure.

Renal-related adverse reactions resulted in a similar discontinuation rate on lesinurad 200 mg in combination with allopurinol (1.0%) and allopurinol alone (1.0%) and a higher rate on lesinurad 400 mg in combination with allopurinol (3.2%). Serious renal-related adverse reactions were reported in patients on lesinurad 400 mg in combination with allopurinol (0.7%) and allopurinol alone (0.2%) and in no patients on lesinurad 200 mg in combination with allopurinol during the 12-month controlled period of the studies. Serious renal-related adverse reactions were reported with lesinurad 200 mg and lesinurad 400 mg in combination with allopurinol in the uncontrolled long-term extensions [see WARNINGS AND PRECAUTIONS].

Cardiovascular Safety

Cardiovascular events and deaths were adjudicated as Major Adverse Cardiovascular Events (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) in the Phase 3 randomized controlled studies of lesinurad in combination with allopurinol. In the randomized controlled studies, the numbers of patients with adjudicated MACE events (incidences per 100 patient-years of exposure) were: 2 (0.60) for placebo, 2 (0.61) for lesinurad 200 mg, and 6 (1.85) for lesinurad 400 mg when used in combination with allopurinol.

Other Adverse Reactions

Adverse reactions occurring in 2% or more of patients on lesinurad in combination with a xanthine oxidase inhibitor and at least 1% greater than that observed in patients on placebo with a xanthine oxidase inhibitor were identified in the lesinurad development program. The incidence of these adverse reactions in controlled studies with lesinurad 200 mg in combination with allopurinol is summarized in Table 4.

Table 4: Incidence in Controlled Studies With Lesinurad in Combination With Allopurinol of Adverse Reactions Identified in the Lesinurad Development Program

Adverse Reaction Placebo + Allopurinol
(N=407)
Lesinurad 200 mg + Allopurinol
(N=405)
Headache 3.2% 4.2%
Influenza 2.9% 4.9%
Gastroesophageal reflux disease 0.5% 3.2%

Postmarketing Experience

Allopurinol

The following adverse reactions have been identified during post approval use of allopurinol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most frequent adverse reaction to allopurinol is skin rash [see WARNINGS AND PRECAUTIONS].

Most Common Adverse Reactions

Gastrointestinal disorders: diarrhea, nausea

Investigations: blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased

Skin and subcutaneous tissue disorders: rash, rash maculo-papular

Less Common (<1%) Adverse Reactions

Blood and lymphatic system disorders: ecchymosis, thrombocytopenia, eosinophilia, leukocytosis, leukopenia

Gastrointestinal disorders: vomiting, abdominal pain, gastritis, dyspepsia

General disorders and administration site conditions: pyrexia

Hepatobiliary disorders: hepatitis (including hepatic necrosis and granulomatous hepatitis), hepatomegaly, hyperbilirubinemia, cholestatic jaundice

Musculoskeletal and connective tissue disorders: myopathy, arthralgia

Nervous system disorders: headache, peripheral neuropathy, neuritis, paresthesia, somnolence, ageusia (taste loss)

Renal and urinary disorders: renal failure, azotemia

Respiratory, thoracic and mediastinal disorders: epistaxis

Skin and subcutaneous tissue disorders: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, leukocytoclastic vasculitis, purpura, bullous dermatitis, exfoliative dermatitis, eczema, pruritus, urticaria, alopecia, onycholysis, lichen planus

Vascular disorders: vasculitis necrotizing, vasculitis

Other Uncommon (<1%) Adverse Events

Blood and lymphatic system disorders: aplastic anemia, agranulocytosis, pancytopenia, anemia, hemolytic anemia, reticulocytosis, lymphadenopathy, lymphocytosis

Cardiac disorders: pericarditis, bradycardia

Endocrine disorders: hypercalcemia, gynecomastia

Eye disorders: cataract, retinitis, iritis, conjunctivitis, amblyopia

Gastrointestinal disorders: hemorrhagic pancreatitis, gastrointestinal hemorrhage, stomatitis, salivary gland enlargement, tongue edema

General disorders and administration site conditions: malaise, asthenia, hyperhidrosis

Infections and infestations: pharyngitis, rhinitis

Investigations: prothrombin level decreased

Metabolism and nutrition disorders: hyperlipidemia, decreased appetite

Musculoskeletal and connective tissue disorders: myalgia

Nervous system disorders: optic neuritis, confusional state, dizziness, vertigo, peroneal nerve palsy, amnesia, tinnitus, insomnia

Psychiatric disorders: libido decreased, depression, erectile dysfunction

Renal and urinary disorders: nephritis, hematuria, albuminuria

Reproductive system and breast disorders: infertility male

Respiratory, thoracic and mediastinal disorders: bronchospasm, asthma

Skin and subcutaneous tissue disorders: furuncle, face edema, skin edema

Vascular disorders: peripheral vascular disorder, thrombophlebitis, vasodilatation

Read the entire FDA prescribing information for Duzallo (Lesinurad and Allopurinol Tablets)

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© Duzallo Patient Information is supplied by Cerner Multum, Inc. and Duzallo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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