Fortunately for adults with gout, medicines to help prevent gout flares are available. One such medicine is called colchicine. Let’s take a closer look at gout flare prevention and colchicine, the active ingredient in Mitigare®

Colchicine, which comes from a plant known as the autumn crocus or meadow saffron, was discovered centuries ago. Colchicine has since been approved by the US Food and Drug Administration (FDA) to help prevent gout flares in adults.

Aiming for Fewer Gout Flares

Colchicine is the active ingredient in a medicine called Mitigare®. It has been proven effective in helping prevent flares in adults with gout.1

Adults who took colchicine 0.6 mg daily had fewer gout flares than patients who did not. Adults who took colchicine also had fewer gout flares as time went on.1

A closer look at gout flare prevention: study demonstrated colchicine reduced the frequency of gout flares.

43 patients starting allopurinol were randomized to receive cochicine 0.6 mg or placebo for up to 6 months. The chart shows the mean number of acute gout flares at the 0-3 and 3-6 month time periods and overall.

A closer look at gout flare prevention: study shows colchicine reduced the severity of gout attacks.

Prophylactic colchicine, in doses of 0.5 to 2.0 mg per day, was given for periods of not less than 2 to no more than 10 years (mean 5.4 years) to 208 gouty subjects selected for analysis because of a prior history of frequent and disabling attacks of acute gouty arthritis.

 

Safety Profile

Colchicine is the active ingredient in Mitigare®. In a 6-month study of patients with recurrent gout, colchicine 0.6 mg was well tolerated.1

  • The most common adverse reactions were gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.
  • 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. Please see Important Safety Information below.

What else can I do to manage my gout flares?

To stay healthy and minimize the impact of gout flares on your life, follow your doctor’s advice and take medicines as prescribed. It may also help to3:

  • Drink plenty of non-alcoholic and non-sugary beverages, especially water. These kinds of fluids help remove uric acid from the body.
  • Avoid foods containing purines. Foods that are high in purines include red meat, organ meats and certain kinds of seafood.
  • Maintain a healthy body weight through diet and exercise.

Discover more helpful information in our Lifestyle Tips and a Gout Flare Prevention Blog.

References

  1. Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004 Dec;31(12):2429-2432.
  2. Yu TF, Gutman AB. 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.
  3. 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.

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.