brand name: auvi-q - monthly prescribing...
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New Product Slideshow
Zurampic (lesinurad)
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Introduction
Brand name: Zurampic
Generic name: Lesinurad
Pharmacological class: URAT1 inhibitor
Strength and Formulation: 200mg; tablets
Manufacturer: Ironwood
How supplied: Bottles—5, 30, 90
Legal Classification: Rx
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ZURAMPIC
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Indications
In combination with a xanthine oxidase inhibitor (including allopurinol or febuxostat), to treat hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone
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Limitations of Use
Not for treatment of asymptomatic hyperuricemia
Not for use as monotherapy
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Dosage & Administration
Take in the AM with food and water
200mg once daily with a xanthine oxidase inhibitor
Max 200mg daily
Patients on daily allopurinol dose <300mg (or <200mg with eCLCr <60mL/min): not recommended
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Considerations for Special Populations
Pregnancy: No human data to inform a drug-associated risk
Nursing mothers: Consider benefits and potential adverse effects
Pediatric: <18yrs: not established
Geriatric: No overall differences in safety or
efficacy observed
Hepatic impairment: Severe: not recommended
Renal impairment: See Warnings/Precautions
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Contraindications
Severe renal impairment (eCLCr <30mL/min), ESRD, kidney transplant recipients, or dialysis patients
Tumor lysis syndrome or Lesch-Nyhan syndrome
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Warnings/Precautions
Risk of acute renal failure when used without a xanthine oxidase inhibitor
Assess renal function prior to initiation and periodically thereafter
Renal impairment (eCLCr <45mL/min): do not initiate
If eCLCr <60mL/min or with serum creatinine (SCr) elevations 1.5–2X pre-treatment value: monitor more frequently; if SCr >2X pre-treatment value: interrupt treatment
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Warnings/Precautions
Discontinue therapy if eCLCr is persistently <45mL/min
Maintain adequate hydration (2 liters of liquid per day)
Give gout flare prophylaxis
Females should use additional non-hormonal methods of contraception
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Interactions
Caution with concomitant moderate CYP2C9 inhibitors (eg, fluconazole, amiodarone) and in CYP2C9 poor metabolizers
Antagonized by moderate CYP2C9 inducers (eg, rifampin, carbamazepine), aspirin >325mg/day (in combination with allopurinol)
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Interactions
Antagonizes CYP3A substrates (eg, sildenafil, amlodipine)
May affect sensitive CYP3A substrates (eg, HMG-CoA reductase inhibitors); monitor
Concomitant epoxide hydrolase inhibitors (eg, valproic acid): not recommended
May reduce efficacy of hormonal contraceptives
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Adverse Reactions
Headache
Influenza
Blood creatinine increase
GERD
Gout flares
Renal events
Cardiovascular events
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Mechanism of Action
Lesinurad reduces serum uric acid levels by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney
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Clinical Trials
The efficacy of Zurampic 200mg and
Zurampic 400mg once daily was studied in 3 multicenter, randomized, double-blind, placebo-controlled studies in adults with hyperuricemia and gout in combination with allopurinol or febuxostat; prophylaxis with colchicine or NSAIDs for the first 5 months of Zurampic therapy were given
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Clinical Trials
In Study 1 (n=603) and Study 2 (n=610), Zurampic 200mg with allopurinol was superior to allopurinol alone in lowering serum uric acid to <6mg/dL at Month 6
In Study 3, gout patients with measurable tophi were randomized to Zurampic 200mg, Zurampic 400mg, or placebo in combination with febuxostat
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Clinical Trials
There was no statistical difference in the proportion of patients treated with Zurampic 200mg in combination with febuxostat achieving serum uric acid <5mg/dL by Month 6 compared with febuxostat alone
The rates of gout flare requiring treatment from Month 6 to 12 were not statistically different between Zurampic with allopurinol or febuxostat compared with allopurinol or febuxostat alone
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Clinical Trials
In Study 3, the proportion of patients who had complete resolution of ≥1 tophus did not statistically differ between Zurampic with febuxostat compared with febuxostat alone
For more clinical trial data, see full labeling
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New Product Monograph
For more information view the product monograph available at: http://www.empr.com/zurampic/drug/34561/