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Zurampic

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

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/7/2018

Zurampic (lesinurad) is a URAT1 inhibitor indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. Common side effects of Zurampic include:

The recommended dose of Zurampic is 200 mg once daily in combination with a xanthine oxidase inhibitor, including allopurinol or febuxostat. The maximum daily dose of Zurampic is 200 mg. Zurampic may interact with fluconazole, amiodarone, rifampin, carbamazepine, HMG-CoA reductase inhibitors, valproic acid, hormonal contraceptives, and aspirin. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or become pregnant while taking Zurampic. Zurampic may reduce the effectiveness of hormonal contraceptives. Females should use additional methods of contraception and not rely on hormonal contraception alone when taking Zurampic. It is unknown if Zurampic passes into breast milk. Consult your doctor before breastfeeding.

Our Zurampic (lesinurad) tablets 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.

Zurampic 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.

Although other doses have been studied, the recommended dose of ZURAMPIC is 200 mg once daily in combination with a xanthine oxidase inhibitor.

In 3 randomized, placebo-controlled studies of ZURAMPIC in combination with a xanthine oxidase inhibitor (Studies 1 and 2 were with allopurinol and Study 3 was with febuxostat) for up to 12 months, a total of 511, 510, and 516 patients were treated with ZURAMPIC 200 mg, ZURAMPIC 400 mg, and placebo, respectively. The mean duration of treatment with ZURAMPIC was 11.2 months. The mean age of the population was 52 years (18-82), and 95% were males. At baseline, 62% of the patient population showed mild or moderate renal impairment (eCLcr less than 90 mL/min) and 79% of patients had at least one co-morbid condition including hypertension (65%), hyperlipidemia (45%), diabetes (17%), and kidney stones (12%).

Renal Events

ZURAMPIC 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 ZURAMPIC 400 mg, when used as monotherapy or in combination with a xanthine oxidase inhibitor [see WARNINGS AND PRECAUTIONS].

The number of patients with serum creatinine elevations in the 12-month placebo-controlled trials in combination with a xanthine oxidase inhibitor are shown in Table 1. Most of these elevations on ZURAMPIC 200 mg and ZURAMPIC 400 mg resolved without treatment interruption (Table 1).

Table 1: Patients with Elevated Serum Creatinine Values in the Placebo-Controlled Clinical Studies with ZURAMPIC in Combination with a Xanthine Oxidase Inhibitor (XOI)

[n (%)] Placebo +XOI (N=516) ZURAMPIC 200 mg + XOI (N=511) ZURAMPIC 400 mg + XOI (N=510)
Serum creatinine elevation 1.5 x to < 2.0 x baseline 12 (2.3%) 20 (3.9%) 51 (10.0%)
  Resolution of serum creatinine elevations by end of study 9/12 (75.0%) 18/20 (90.0%) 42/51 (82.4%)
Serum creatinine elevation ≥ 2.0 x baseline 0 9 (1.8%) 34 (6.7%)
  Resolution of serum creatinine elevations by end of study N/A 8/9 (88.9%) 26/34 (76.5%)

Renal-related adverse reactions, including blood creatinine increases and renal failure, and nephrolithiasis reported in patients receiving ZURAMPIC 200 mg, ZURAMPIC 400 mg and placebo in combination with a xanthine oxidase inhibitor are shown in Table 2 [see WARNINGS AND PRECAUTIONS]. The incidence of reports of “blood creatinine increased” was higher with ZURAMPIC and was highest with ZURAMPIC 400 mg. 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 ZURAMPIC in combination with a xanthine oxidase inhibitor across baseline renal function categories (Table 3).

Table 2: Incidence of Renal-Related Adverse Reactions and Nephrolithiasis in Placebo-Controlled Clinical Studies with ZURAMPIC in Combination with a Xanthine Oxidase Inhibitor (XOI)

[n (%)] Placebo + XOI (N=516) ZURAMPIC 200 mg + XOI (N=511) ZURAMPIC 400 mg + XOI (N=510)
Blood creatinine increased 12 (2.3%) 22 (4.3%) 40 (7.8%)
Renal failure1 11 (2.1%) 6 (1.2%) 18 (3.5%)
Nephrolithiasis 9 (1.7%) 3 (0.6%) 13 (2.5%)
1Renal 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 ZURAMPIC in Combination with a Xanthine Oxidase Inhibitor (XOI)

n (%) Placebo + XOI ZURAMPIC 200 mg + XOI ZURAMPIC 400 mg + XOI
≥ 90 mL/min n=180 n=200 n=203
  Blood creatinine increased 1 (0.6%) 6 (3.0%) 12 (5.9%)
  Renal failure1 0 3 (1.5%) 7 (3.4%)
≥ 60 - < 90 mL/min n=229 n=208 n=213
  Blood creatinine increased 4 (1.7%) 8 (3.8%) 21 (9.9%)
  Renal failure1 4 (1.7%) 1 (0.5%) 7 (3.3%)
≥ 30 - < 60 mL/min n=101 n=101 n=92
  Blood creatinine increased 6 (5.9%) 7 (6.9%) 10 (10.9%)
  Renal failure1 5 (5.0%) 2 (2.0%) 4 (4.3%)
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 ZURAMPIC 200 mg in combination with a xanthine oxidase inhibitor (1.2%) and a xanthine oxidase inhibitor alone (1%) and a higher rate on ZURAMPIC 400 mg in combination with a xanthine oxidase inhibitor (3.3%). Serious renal-related adverse reactions were reported in patients on ZURAMPIC 400 mg in combination with a xanthine oxidase inhibitor (1%) and a xanthine oxidase inhibitor alone (0.4%) and in no patients on ZURAMPIC 200 mg in combination with a xanthine oxidase inhibitor during the 12-month controlled period of the studies. Serious renal-related adverse reactions were reported with ZURAMPIC 200 mg and ZURAMPIC 400 mg in the uncontrolled long-term extensions.

Monotherapy

In a 6-month double-blind, placebo-controlled monotherapy study, renal failure (9.3%), blood creatinine increased (8.4%), and nephrolithiasis (0.9%) were reported in patients receiving ZURAMPIC 400 mg alone and in no patients receiving placebo [see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION]. Serum creatinine elevations 1.5-fold or greater occurred in 24.3 % of patients receiving ZURAMPIC 400 mg and in no patients receiving placebo.

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 ZURAMPIC. In the randomized controlled studies, the numbers of patients with adjudicated MACE events (incidences per 100 patient-years of exposure) were: 3 (0.71) for placebo, 4 (0.96) for ZURAMPIC 200 mg, and 8 (1.94) for ZURAMPIC 400 mg when used in combination with a xanthine oxidase inhibitor. Incidence rate ratios for ZURAMPIC 200 mg and 400 mg compared with placebo were 1.36 (95% CI: 0.23, 9.25) and 2.71 (95% CI: 0.66, 16.00), respectively.

Other Adverse Reactions

Adverse reactions occurring in 2% or more of patients on ZURAMPIC 200 mg in combination with a xanthine oxidase inhibitor and at least 1% greater than that observed in patients on placebo with a xanthine oxidase inhibitor are summarized in Table 4.

Table 4: Adverse Reactions Occurring in ≥ 2% of ZURAMPIC 200 mg-Treated Patients and at Least 1% Greater than Seen in Patients Receiving Placebo in Controlled Studies with ZURAMPIC in Combination with a Xanthine Oxidase Inhibitor (XOI)

Adverse Reaction Placebo + XOI (N=516) ZURAMPIC 200 mg + XOI (N=511)
Headache 4.1% 5.3%
Influenza 2.7% 5.1%
Gastroesophageal reflux disease 0.8% 2.7%

Read the entire FDA prescribing information for Zurampic (Zurampic Lesinurad Tablets)

Related Resources for Zurampic

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

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