Signs your patients’ gout
may remain uncontrolled

Close

See the clinical efficacy and
safety profile of DUZALLO

Close
For US Healthcare Professionals Only
What your patients do not want you to know about their gout2

Findings from a 2017 national survey* of 1000 patients with gout and 500 caregivers:

of patients do not report all their flares to their doctors
of patients try to hide flares from their loved ones
gout flares per year (mean)
days per year of missed work because of gout flares
Hyperuricemia in gout has two causes: overproduction and underexcretion of uric acid.3
Scroll down to learn more about both mechanisms of disease
* Data from an online survey conducted by Edelman Intelligence on behalf of CreakyJoints®, with funding provided by Ironwood Pharmaceuticals, Inc.
Hyperuricemia in gout is caused by 2 mechanisms that affect uric acid levels3

The current standard of care in gout, allopurinol monotherapy, addresses overproduction of uric acid.1,4

For the majority of patients with gout, underexcretion of uric acid is a main contributor to elevated serum uric acid (sUA).5

Overproduction of uric acid is addressed with a xanthine oxidase inhibitor, such as allopurinol1
Underexcretion of uric acid is addressed with a uricosuric, such as lesinurad1
In gout patients when a medically appropriate daily dose of allopurinol alone is not enough to achieve goal sUA,
DUZALLO is the first and only therapy that addresses both mechanisms of hyperuricemia in gout with one pill.1,3
In a clinical trial setting, less than 50% of patients achieved sUA <6 mg/dL on allopurinol 300 mg monotherapy6-8

ACR guidelines recommend the goal of gout management is to achieve sUA <6 mg/dL for all patients with gout. This is below the saturation point of uric acid, 6.8 mg/dL, the point at which uric acid precipitates from the blood and crystallizes in joints.9

  • In the clinical trials supporting the FDA approval of DUZALLO,* patients received a stable dose of allopurinol (300 mg to 800 mg, or ≥200 mg for patients with moderate renal impairment)1
    • ~90% of patients in the clinical trials were taking allopurinol 300 mg4,10
  • DUZALLO may be appropriate when goal sUA levels <6 mg/dL are not achieved on a medically appropriate daily dose of allopurinol monotherapy1
Patients with gout and an eCLcr ≥45 mL/min now have another treatment option.1
* Bioequivalence of DUZALLO to coadministered lesinurad and allopurinol was demonstrated. Efficacy of the combination of lesinurad and allopurinol versus allopurinol alone has been demonstrated in 2 randomized, double-blind, placebo-controlled phase III studies (CLEAR 1 and CLEAR 2). There have been no phase III clinical trials with DUZALLO.1
Eligible commercially insured patients may pay
$0 copay for the first 30-day fill and pay as little as $15 per 30-day refill*
Subject to eligibility. Restrictions apply.
See eligibility, terms, and conditions.
*Or $30 per 90-day refill.

Eligibility and use

Program Eligibility Criteria, Terms and Conditions 1. This offer is valid only for patients 18 years of age or older and is restricted to residents of, and good only in, the United States at participating pharmacies. 2. You may be eligible for this offer if you are insured by commercial insurance and your insurance does not cover the full cost of your prescription. 3. Patients who are enrolled in a federally or state funded prescription insurance program (including any state pharmaceutical assistance programs), are not eligible for this offer. This includes patients enrolled in Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DOD) programs or TriCare, patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees, and patients in private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. 4. If you are enrolled in a state or federally funded prescription insurance program, you may not use this Savings Card even if you elect to be processed as an uninsured (cash-paying) patient. 5. This offer is not valid for cash-paying patients. 6. This offer is not health insurance and is valid for retail prescriptions only and is good for use only by eligible commercially insured patients with a valid prescription for Duzallo® (lesinurad and allopurinol) at the time the prescription is filled by the pharmacist and dispensed to the patient. Depending on your insurance coverage, eligible patients may (a) pay $0 for their first prescription fill of a 30-day supply and may pay as little as $15 per prescription refill for each of up to eleven (11) additional prescription refills of a 30-day supply of Duzallo or (b) pay as little as $30 for each of up to four (4) prescription fills of a 90-day supply of Duzallo. Check with your pharmacist for your copay discount. Maximum savings limit applies; patient out-of-pocket expense may vary. 7. This offer is valid for up to twelve (12) prescription fills of a 30-day supply or up to four (4) prescription fills of a 90-day supply. Prescriptions must be filled before the program expires on 12/31/18. 8. Offer void where prohibited by law, taxed, or restricted. 9. This card is not transferable. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. 10. This card has no cash value and may not be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specified prescription. 11. This card expires December 31, 2018. 12. Ironwood reserves the right to rescind, revoke, or amend this offer, eligibility, and terms of use at any time without notice. 13. This offer is not conditioned on any past, present, or future purchase, including refills. 14. By redeeming this card, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.

By enrolling in this program, you are consenting to the collection and use of certain personal information, including your email address and elements of pharmacy claim information, and to receive periodic DUZALLO refill reminders and additional program messages. This information will be collected and used by service providers of DUZALLO in order to administer this program. This personal information will be provided to Ironwood Pharmaceuticals. If you do not consent, please do not enroll into the program.

For questions about this program, please call 1-855-636-9116

Pharmacist Certification: When you redeem this card, you certify that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other government programs for this prescription.

Pharmacist Instructions for a Patient with an Eligible Third-Party Payer:

  • Submit the claim to the primary insurance first, then submit the balance due to Change Healthcare as a Secondary Payer coordination of benefits (COB) with patient responsibility amount and a valid Other Coverage Code, eg, 8
  • If you receive an NDC Not Covered or Product Not Covered rejection from the primary insurance, submit the balance due to Change Healthcare as a Secondary Payer with an other coverage code of 3
  • If you receive a rejection from the primary insurance due to prior authorization (PA) or step edit requirements, contact the provider to initiate the PA/step edit
  • Valid Other Coverage Code required
  • The patient’s out-of-pocket expense will be reduced up to the maximum savings limit for the program. Reimbursement will be received from Change Healthcare
  • For any questions regarding Change Healthcare online processing, please call the Pharmacy Help Desk at 1-866-440-3808

Program managed by COMP, LLC on behalf of Ironwood Pharmaceuticals.

Program terms, conditions,
and eligibility criteria   
Are your patients ready to try DUZALLO?
Get to know the first and only therapy that addresses both mechanisms of hyperuricemia in gout with one pill.1,3

Open/Close

Important Safety Information

WARNING: RISK OF ACUTE RENAL FAILURE

  • Acute renal failure has occurred with lesinurad, one of the components of DUZALLO

Contraindications:

  • Severe renal impairment (estimated creatinine clearance [eCLcr] <30 mL/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis
  • Tumor lysis syndrome or Lesch-Nyhan syndrome
  • Known hypersensitivity to allopurinol, including previous occurrence of skin rash

Warnings and Precautions:

  • Renal events: Adverse reactions related to renal function, including acute renal failure, can occur after initiating DUZALLO. Renal function should be evaluated prior to initiation of DUZALLO and periodically thereafter, as clinically indicated. More frequent renal function monitoring is recommended in patients with eCLcr <60 mL/min or with serum creatinine elevations 1.5 to 2 times the value when lesinurad treatment was initiated. DUZALLO should not be initiated in patients with an eCLcr <45 mL/min. Interrupt treatment with DUZALLO if serum creatinine is elevated to >2 times the pretreatment value or if there are symptoms that may indicate acute uric acid nephropathy, including flank pain, nausea, or vomiting. DUZALLO should not be restarted without another explanation for the serum creatinine abnormalities
  • Skin rash and hypersensitivity: Skin rash is a frequently reported adverse event in patients taking allopurinol. In some instances, a skin rash may be followed by more severe hypersensitivity reactions associated with exfoliation, fever, lymphadenopathy, arthralgia, and/or eosinophilia including Stevens-Johnson syndrome and toxic epidermal necrolysis. Associated vasculitis and tissue response may be manifested in various ways including hepatitis, renal impairment, seizures, and on rare occasions, death. Hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function who are receiving thiazide diuretics and DUZALLO concurrently. DUZALLO should be discontinued immediately at the first appearance of skin rash or other signs that may indicate an allergic reaction, and additional medical care should be provided as needed
  • Hepatotoxicity: A few cases of reversible clinical hepatotoxicity have been reported in patients taking allopurinol and, in some patients, asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed. If anorexia, weight loss, or pruritus develops in patients taking DUZALLO, evaluation of liver function should be performed. In patients with preexisting liver disease, periodic liver function tests are recommended
  • Cardiovascular events: In clinical trials, major adverse cardiovascular events (defined as cardiovascular deaths, nonfatal myocardial infarctions, and nonfatal strokes) were observed with DUZALLO. A causal relationship has not been established
  • Bone marrow depression: Bone marrow depression has been reported in patients receiving allopurinol, most of whom received concomitant drugs with the potential for causing this reaction. This has occurred as early as 6 weeks to as long as 6 years after the initiation of allopurinol therapy. Rarely, a patient may develop varying degrees of bone marrow depression, affecting one or more cell lines, while receiving allopurinol alone. Patients taking allopurinol and mercaptopurine or azathioprine require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine
  • Increase in prothrombin time: It has been reported that allopurinol prolongs the half-life of dicumarol, a coumarin anticoagulant. The prothrombin time should be reassessed periodically in patients receiving coumarin anticoagulants (dicumarol, warfarin) concomitantly with DUZALLO
  • Drowsiness: Occasional occurrence of drowsiness was reported in patients taking allopurinol. Patients should be alerted to the need for caution when engaging in activities where alertness is mandatory

Adverse Reactions:

  • The most common adverse reactions in controlled studies (occurring in 2% or more of patients on lesinurad in combination with allopurinol and at least 1% greater than observed in patients on allopurinol alone) were headache, influenza, blood creatinine increased, and gastroesophageal reflux disease
  • The most common adverse reactions identified during post-approval use of allopurinol are skin rash, nausea, and diarrhea

Indication and Limitations of Use:

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.

  • DUZALLO is not recommended for the treatment of asymptomatic hyperuricemia

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.

Important Safety Information

WARNING: RISK OF ACUTE RENAL FAILURE

  • Acute renal failure has occurred with lesinurad, one of the components of DUZALLO

Contraindications:

  • Severe renal impairment (estimated creatinine clearance [eCLcr] <30 mL/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis
  • Tumor lysis syndrome or Lesch-Nyhan syndrome
  • Known hypersensitivity to allopurinol, including previous occurrence of skin rash

Warnings and Precautions:

  • Renal events: Adverse reactions related to renal function, including acute renal failure, can occur after initiating DUZALLO. Renal function should be evaluated prior to initiation of DUZALLO and periodically thereafter, as clinically indicated. More frequent renal function monitoring is recommended in patients with eCLcr <60 mL/min or with serum creatinine elevations 1.5 to 2 times the value when lesinurad treatment was initiated. DUZALLO should not be initiated in patients with an eCLcr <45 mL/min. Interrupt treatment with DUZALLO if serum creatinine is elevated to >2 times the pretreatment value or if there are symptoms that may indicate acute uric acid nephropathy, including flank pain, nausea, or vomiting. DUZALLO should not be restarted without another explanation for the serum creatinine abnormalities
  • Skin rash and hypersensitivity: Skin rash is a frequently reported adverse event in patients taking allopurinol. In some instances, a skin rash may be followed by more severe hypersensitivity reactions associated with exfoliation, fever, lymphadenopathy, arthralgia, and/or eosinophilia including Stevens-Johnson syndrome and toxic epidermal necrolysis. Associated vasculitis and tissue response may be manifested in various ways including hepatitis, renal impairment, seizures, and on rare occasions, death. Hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function who are receiving thiazide diuretics and DUZALLO concurrently. DUZALLO should be discontinued immediately at the first appearance of skin rash or other signs that may indicate an allergic reaction, and additional medical care should be provided as needed
  • Hepatotoxicity: A few cases of reversible clinical hepatotoxicity have been reported in patients taking allopurinol and, in some patients, asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed. If anorexia, weight loss, or pruritus develops in patients taking DUZALLO, evaluation of liver function should be performed. In patients with preexisting liver disease, periodic liver function tests are recommended
  • Cardiovascular events: In clinical trials, major adverse cardiovascular events (defined as cardiovascular deaths, nonfatal myocardial infarctions, and nonfatal strokes) were observed with DUZALLO. A causal relationship has not been established
  • Bone marrow depression: Bone marrow depression has been reported in patients receiving allopurinol, most of whom received concomitant drugs with the potential for causing this reaction. This has occurred as early as 6 weeks to as long as 6 years after the initiation of allopurinol therapy. Rarely, a patient may develop varying degrees of bone marrow depression, affecting one or more cell lines, while receiving allopurinol alone. Patients taking allopurinol and mercaptopurine or azathioprine require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine
  • Increase in prothrombin time: It has been reported that allopurinol prolongs the half-life of dicumarol, a coumarin anticoagulant. The prothrombin time should be reassessed periodically in patients receiving coumarin anticoagulants (dicumarol, warfarin) concomitantly with DUZALLO
  • Drowsiness: Occasional occurrence of drowsiness was reported in patients taking allopurinol. Patients should be alerted to the need for caution when engaging in activities where alertness is mandatory

Adverse Reactions:

  • The most common adverse reactions in controlled studies (occurring in 2% or more of patients on lesinurad in combination with allopurinol and at least 1% greater than observed in patients on allopurinol alone) were headache, influenza, blood creatinine increased, and gastroesophageal reflux disease
  • The most common adverse reactions identified during post-approval use of allopurinol are skin rash, nausea, and diarrhea

Indication and Limitations of Use:

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.

  • DUZALLO is not recommended for the treatment of asymptomatic hyperuricemia

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.

References: 1. DUZALLO [package insert]. 2017. 2. Data on file. 2017 Gout Patient/Caregiver Survey with Creaky Joints. 2017. 3. American College of Rheumatology. Gout. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Gout. Accessed August 2, 2017. 4. Bardin T, Keenan RT, Khanna PP, et al. Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study). Ann Rheum Dis. 2017;76(5):811-820. 5. Boss GR, Seegmiller JE. Hyperuricemia and gout: classification, complications and management. N Engl J Med. 1979;300(26):1459-1468. 6. Becker MA, Schumacher HR, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005;353(23):2450-2461. 7. Schumacher HR Jr, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008;59(11):1540-1548. 8. Becker MA, Schumacher HR Jr, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. 9. Khanna D, Fitzgerald JD, Khanna PP, et al; for the American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res (Hoboken). 2012;64(10):1431-1446. 10. Saag KG, Fitz-Patrick D, Kopicko J, et al. Lesinurad combined with allopurinol: a randomized, double-blind, placebo-controlled study in gout patients with an inadequate response to standard-of-care allopurinol (a US-based study). Arthritis Rheumatol. 2017;69:203-212.