If you have ever suffered a gout flare, you know one thing for sure—you never want it to happen again. Understanding gout is key.

Mitigare® (colchicine) 0.6 mg capsules may help. Mitigare® is an FDA-approved medicine for the prevention of gout flares in adults. And it is the only colchicine medication available as a capsule. Read on to learn more about gout and how Mitigare® can help prevent flares.

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.

Start with the Basics

What is gout?

Gout is a form of inflammatory arthritis. For many people, gout begins in the big toe. However, other joints can be affected, including the ankles, heels, knees, wrists, fingers and elbows.1

Unlike other types of arthritis, gout is caused by a build-up of uric acid in the body. This build-up of uric acid can lead to deposits of urate crystals around the joints. Once they form in the joints, these crystals can cause redness, swelling, stiffness and intense pain.1

The excess uric acid can result in tophi (TOE-fye), which look like small white or yellow lumps under the skin. These lumps usually appear around the joints and sometimes in the rim of the ear. Excess uric acid can also collect in the kidneys and lead to kidney stones. Because the uric acid builds up over time, symptoms may take months or even years to appear.1

Your first gout flare might last three to 10 days. Months or years may pass before another flare occurs. Eventually, however, gout flares become more frequent and painful.1

 

What causes gout?

Gout has a number of potential causes, including:

  • Genetics. For many people with gout, it is hereditary. This is true of approximately 20 to 80 percent of people with gout.1
  • Gender. Although women can be affected by gout, it is more common in men.1
  • Weight. Being overweight increases the risk of uric acid build-up in the body. This is because there is more tissue available for turnover or breakdown, which can cause excess uric acid production.1
  • Alcohol consumption. Because drinking alcohol interferes with the removal of uric acid from the body, uric acid can build up and cause flares.1 Alcohol also contains purines, which are naturally occurring substances the body breaks down into uric acid.1,2 The excess uric acid can build up and trigger gout flares.1
  • Diet. Consuming too many foods or beverages that are rich in purines can cause or trigger a gout flare. Foods that are high in purines include red meat, organ meats and certain kinds of seafood.1
  • Lead exposure. Exposure to lead can cause gout or make existing gout worse.1
  • Other health problems. Because uric acid leaves the body through the kidneys, renal insufficiency (the inability of the kidneys to eliminate waste products) is a common cause of gout in older adults. Other medical problems linked to gout include high blood pressure, hypothyroidism (underactive thyroid), certain cancers (or other medical conditions that cause rapid cell growth) and Kelley-Seegmiller syndrome or Lesch-Nyhan syndrome (rare conditions in which the enzyme that helps control uric acid levels is either absent or insufficient).1
  • Certain medicines. A number of different medicines can cause hyperuricemia and gout, including diuretics, aspirin (and other salicylate-containing drugs), niacin, cyclosporine and levodopa.1

 

What does a gout flare feel like?

An acute gout flare often occurs at night and can cause sudden intense pain and swelling. The affected joint may also be warm, stiff and very tender. A gout flare usually subsides within three to 10 days.1

What You Need to Know

Who is affected by gout?

Although the majority of people who suffer with gout are men, many women are affected by the disease.3

Understanding gout is key for people who are affected by the disease.

There can be important differences between male and female patients. For example, most men with gout develop the condition in their mid-fifties. For most women with gout, it tends to appear in their mid-sixties.5

Some common medical conditions among people with gout include6:

  • Obesity
  • Metabolic syndrome (a group of risk factors that raise your risk of heart disease and other health problems, such as diabetes and stroke)
  • Diabetes
  • Hypertension (high blood pressure)
  • Hyperlipidemia (high cholesterol)
  • Congestive heart failure

 

Why is it important to tell my doctor if I think I have gout?

Prompt treatment of gout is important. If untreated, the risk of a second gout attack after one year is 62 percent. The risk of a second attack increases to 78 percent after two years, and 93 percent after 10 years.7

If gout is untreated for a long period, say 10 years, it can become very severe and even disabling. By this time, the disease may have permanently damaged the affected joints and even the kidneys.1

If you think you may have gout, talk with your doctor. He or she will be able to recommend lifestyle changes and/or prescribe medicine that can help you manage your gout. Complete and print a short gout discussion questionnaire you can discuss with your doctor at your next appointment.

 

How can I tell if my gout is getting worse?

Your gout may be getting worse if you are having more severe flares and they are happening more often. Be sure to talk to your doctor if you suspect your gout is becoming more severe.1

References

  1. Questions and Answers about Gout. National Institute of Arthritis and Musculoskeletal and Skin Diseases website. Available at: https://www.niams.nih.gov/health_info/gout/. Accessed May 16, 2017.
  2. Kaneko K, Yamanobe T, Fujimori S. Determination of purine contents of alcoholic beverages using high performance liquid chromatography. Biomed Chromatogr. 2009 Aug;23(8):858-864.
  3. Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the US general population: the National Health and Nutrition Examination Survey 2007-2008. Arthritis Rheum. Oct 2011;63(10):3136-3141.
  4. Arthritis/Gout. Centers for Disease Control and Prevention website. Available at: http://www.cdc.gov/arthritis/basics/gout.html. Accessed November 30, 2016.
  5. Dirken-Heukensfeldt KJ, Teunissen T, van de Lisdonk E, Lagro-Janssen A. “Clinical features of women with gout arthritis.” A systematic review. Clin Rheumatol. 2010;29:575-582.
  6. Gow P. Treating gout in patients with comorbidities. Int J Clin Rheumatol. 2011;6(6):625-633.
  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.

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 Pharmaceuticals Corp., Eatontown, NJ 07724

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.