Why It’s Important for Adults to Stay on Preventive Therapy Against Gout Flares

Preventive Therapy

Approximately 8.3 million Americans are currently living with gout.1 Certain lifestyle changes may help manage this painful disease, but medication is the most proven, effective preventive therapy against gout flares.2

One such medication your doctor may prescribe is colchicine. Colchicine, derived from a plant known as the autumn crocus or meadow saffron, was discovered centuries ago.3 Colchicine is the active ingredient in Mitigare® (colchicine) 0.6 mg Capsules. The safety and effectiveness of Mitigare® for acute treatment of gout flares during prophylaxis has not been studied. Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.

 

Preventive therapy with colchicine

In a clinical study, patients who took colchicine 0.6 mg daily had fewer gout flares than patients who did not.4 Patients who took colchicine also had fewer gout flares as time went on.4

 

Forty-three patients starting allopurinol were randomized to receive colchicine 0.6 mg or placebo for up to 6 months.4 The chart shows the mean number of acute gout flares at the 0-3 and 3-6 month time periods, and overall (n=43; colchicine=21, placebo=22).4

 

The same study showed that colchicine 0.6 mg was well tolerated.4 The most commonly reported adverse reactions associated with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting and abdominal pain.5

 

Stay on preventive therapy for as long as your doctor recommends

In addition to helping you avoid the agonizing pain associated with gout flares, there are many reasons why it is important to remain on preventive therapy.

Increasingly frequent flares

After uric acid levels have been high for many years, flares which were once infrequent begin to occur regularly. 6 About 60 percent of people who have had a flare will have another within the next 12 months.6 More than 80 percent will have another flare within the next three years.6 Meanwhile, the pain associated with these increasingly frequent flares can last longer and become even more severe.6

Risk of permanent damage

If gout is untreated for a long period, say 10 years or more, it can become very severe and even disabling.7 In some cases, the disease can permanently damage the affected joints and even the kidneys.8

Help reaching uric acid goals

Urate-lowering therapy (ULT) with prescription medications such as allopurinol, Uloric® (febuxostat), Zurampic® (lesinurad) or Krystexxa® (pegloticase) can be an important part of gout management.9 However, some patients who take these medicines experience more frequent gout flares.9 These flares may be caused by the uric acid crystals in the joints dissolving as the uric acid level in the bloodstream goes down.9

Research suggests that adult gout patients should be made aware of the potential increase in flares associated with ULT.9 It also shows that flare prevention with colchicine may help adult patients remain on ULT and ultimately achieve their gout treatment goals.9

 

Flare prevention is the standard of care

To prevent flares, the American College of Rheumatology (ACR) Guidelines for Management of Gout recommends that patients begin an anti-inflammatory agent before or during ULT.10 The ACR recommends low-dose colchicine (0.5 to 0.6 mg orally once or twice a day) as a first-line option for gout flare prevention.10

 

Important Safety Information

Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining one of these dual inhibitors, or a medication that inhibits either P-gp or CYP3A4, with colchicine has resulted in life-threatening or fatal colchicine toxicity.  

Patients with both renal and hepatic impairment should not use Mitigare®.

Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.

Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia have been reported with colchicine use.

Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.

Please see full Prescribing Information and Medication Guide for Mitigare® for complete product details.

 

Find out more about preventive therapy

To find out more about preventing gout flares with Mitigare, ask your doctor or visit www.Mitigare.com.

 

NOTE: This article was not written by a medical professional and is not intended to substitute the guidance of a physician. These are not West-Ward’s recommendations for gout flare prevention, but rather facts and data collected from various reliable medical sources. For a full list of resources and their attributing links, see below.

All registered trademarks are the property of their respective owners.

References

  1. Zhu Y et al. Prevalence of Gout and Hyperuricemia in the US General Population. The National Health and Nutrition Examination Survey 2007–2008. Arthritis Rheum. 2011;63(10):3136–3141.
  2. Mayo Clinic. Gout. Diagnosis & treatment. https://www.mayoclinic.org/diseases-conditions/gout/diagnosis-treatment/drc-20372903. Accessed 1/2/18.
  3. Nuki G and Simkin PA. A concise history of gout and hyperuricemia and their treatment. Arthritis Res Ther. 2006;8(Suppl 1):S1-S5.
  4. Borstad GC, Bryant LR, Abel MP, et al. Colchicine prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004; 31(12):2429-2432.
  5. Mitigare® (colchicine) capsules [prescribing Information]. Eatontown, NJ: West-Ward Pharmaceutical Corp; 2014.
  6. Arthritis Foundation. What is Gout? http://www.arthritis.org/about-arthritis/types/gout/what-is-gout.php. Accessed 1/2/18.
  7. Yu et al. Efficacy of colchicine prophylaxis in gout. Prevention of recurrent gouty arthritis over a mean period of five years in 208 gouty subjects. Ann Intern Med.1961;55:179–192.
  8. National Institutes of Health. Gout. https://www.niams.nih.gov/Health_Info/Gout/default.asp. Accessed 1/2/18.
  9. Aung T, Myung G, FitzGerald JD. Treatment approaches and adherence to urate-lowering therapy for patients with gout. Patient Prefer Adherence. 2017;11:795–800.
  10. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 2: Therapy and Antiinflammatory Prophylaxis of Acute Gouty Arthritis. Arthritis Care Res (Hoboken). 2012;64:1447–1451 and 1456–1459.

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.
  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.
  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
  • Drug interaction with dual P-gp and CYP3A4 inhibitors: Co-administration of colchicine with dual P-gp and CYP3A4 inhibitors has resulted in life-threatening interactions and death.
  • Neuromuscular toxicity and rhabdomyolysis may occur with chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (including those with normal renal and hepatic function) are at increased risk. Consider temporary interruption or discontinuation of Mitigare®.
  • The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.

Indication

Mitigare® is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied.

Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.

For Full Prescribing Information please CLICK HERE and for Medication Guide CLICK HERE.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.