Lesinurad / allopurinol (Duzallo)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Yashasvi Aryaputra[2];
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Black Box Warning
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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
|
Overview
Lesinurad / allopurinol (Duzallo) is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition 1
- Dosing Information
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Condition 2
- Dosing Information
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
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Non–Guideline-Supported Use
Condition 1
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Condition 2
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Condition 3
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Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
- Dosing Information
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Condition 2
- Dosing Information
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Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
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Non–Guideline-Supported Use
Condition 1
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Condition 2
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Condition 3
- Dosing Information
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Contraindications
CONTRAINDICATIONS
Warnings
|
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
|
Conidition 1
(Description)
Conidition 2
(Description)
Conidition 3
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Postmarketing Experience
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Drug Interactions
- Drug 1
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Drug 1
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Drug 2
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Drug 3
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Drug 4
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Drug 5
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Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lesinurad / allopurinol (Duzallo) in women who are pregnant.
Labor and Delivery
(Description)
Nursing Mothers
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Pediatric Use
(Description)
Geriatic Use
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Gender
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Race
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Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
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Immunocompromised Patients
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Others
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Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
There is limited information regarding the compatibility of Lesinurad / allopurinol (Duzallo) and IV administrations.
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Lesinurad / allopurinol (Duzallo)
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Mechanism of Action
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Structure
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Pharmacodynamics
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Pharmacokinetics
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Nonclinical Toxicology
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Clinical Studies
- Lesinurad in combination with allopurinol has been studied in hyperuricemic gout patients who have not achieved target serum uric acid levels with allopurinol alone.
- There have been no phase 3 clinical trials with DUZALLO. Bioequivalence of DUZALLO to co-administered lesinurad and allopurinol was demonstrated, and efficacy of the combination of allopurinol and lesinurad has been demonstrated in two phase 3 studies (Study 1 and 2).
Lesinurad Add-On to Allopurinol in Inadequate Responders
- Both studies were 12-month multicenter, randomized, double-blind, placebo-controlled clinical studies in adult patients with hyperuricemia and gout. Patients received prophylaxis for gout flares with colchicine or non-steroidal anti-inflammatory drugs (NSAIDs) during the first 5 months of study treatment. Lesinurad 200 mg and 400 mg once daily in combination with allopurinol were studied. Lesinurad 200 mg is the only recommended lesinurad dose, and is the dose combined with allopurinol in DUZALLO.
- Study 1 and Study 2 enrolled patients with gout who were on a stable dose of allopurinol of at least 300 mg (or 200 mg for moderate renal impairment), had a serum uric acid > 6.5 mg/dL, and reported at least 2 gout flares in the prior 12 months. Mean years since gout diagnosis were 12 years. More than half of the patients (61%) had mild or moderate renal impairment and 19% of the patients had tophi. Patients were randomized 1:1:1 to receive lesinurad 200 mg, lesinurad 400 mg, or placebo once daily; all were to continue on their stable allopurinol dose. The majority of patients in these studies received daily allopurinol doses of 200 mg or 300 mg, corresponding to the allopurinol doses contained in DUZALLO. The average dose of allopurinol in the studies was 310 mg (range: 200-900 mg).
- As shown in Table 5, lesinurad 200 mg in combination with allopurinol was superior to allopurinol alone in lowering serum uric acid to less than 6 mg/dL at Month 6.
- The estimated effect of lesinurad 200 mg on serum uric acid in the subgroup of patients taking thiazide diuretics at baseline was similar to the estimated effect in the overall population. The estimated effect was also similar in the subgroup of patients taking low-dose aspirin at baseline.
- As shown in Figure 3, reduction in average serum uric acid levels to < 6 mg/dL was noted for lesinurad 200 mg in combination with allopurinol at the Month 1 visit and was maintained throughout the 12-month studies.
Gout Flares
- In Study 1 and Study 2, the rates of gout flare requiring treatment from the end of Month 6 to the end of Month 12 were not statistically different between lesinurad 200 mg in combination with allopurinol compared with allopurinol alone.
Use in Patients With Renal Impairment
- The estimated differences between lesinurad and placebo in the proportions of patients achieving target serum uric acid levels in the renal impairment subgroups were largely consistent with the results in the overall population in the studies. However, there were limited data in patients with eCLcr less than 45 mL/min and there was a trend toward decreasing magnitude of effect with decreasing renal function. Based on integrated data from Study 1 and Study 2, the estimated difference between lesinurad 200 mg in combination with allopurinol and allopurinol alone in the proportion achieving serum uric acid < 6.0 mg/dL at Month 6 was 10% (95% CI: -17, 37) in those with eCLcr less than 45 mL/min as compared with 27% (95% CI: 9, 45) in the 45 to less than 60 mL/min subgroup and 30% (95% CI: 23, 37) in the 60 mL/min or greater subgroup.
How Supplied
- 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.
Storage
- Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F).
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Administration
- Advise patients:
- To take one tablet of DUZALLO in the morning with food and water.
- Not to take a missed dose of DUZALLO later in the day, but to wait to take DUZALLO on the next day, and not to double the dose.
- Not to take DUZALLO with ZURAMPIC (lesinurad).
- To stay well hydrated (e.g., 2 liters of liquid per day).
Renal Events
- Inform patients that renal events including transient increases in blood creatinine level and acute renal failure have occurred in some patients who take DUZALLO. Advise patients that periodic monitoring of blood creatinine levels is recommended.
Serious Skin Reactions
- Inform patients that DUZALLO may increase the risk of serious skin side effects such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash and seek medical attention.
Gout Flares
- Inform patients that gout flares may occur after initiation of DUZALLO and of the importance of taking gout flare prophylaxis medication to help prevent gout flares. Advise patients not to discontinue DUZALLO if a gout flare occurs during treatment.
Concomitant Use with Other Medications
- Inform patients that use of DUZALLO may increase the risks associated with taking other medications (i.e., coumarin anticoagulants, mercaptopurine, azathioprine and thiazide diuretics) and they should follow the instructions of their healthcare provider.
Ability to Perform Complex Tasks
- Patients should be informed that drowsiness has been reported in patients taking allopurinol. Patients should be alerted to the need for due caution when engaging in activities where alertness is mandatory.
Precautions with Alcohol
Alcohol-Lesinurad / allopurinol (Duzallo) interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
- Duzallo
Look-Alike Drug Names
There is limited information regarding Lesinurad / allopurinol (Duzallo) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.