Prophylaxis is an essential component of gout flare prevention. Colchicine prophylaxis can help reduce the frequency and severity of gout attacks.1,2

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.

Mitigare® Efficacy: Colchicine 0.6 mg reduced the frequency of gout flares.

43 patients starting allopurinol were randomized to receive colchicine 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.

 

Mitigare® Efficacy: Colchicine 0.6 mg reduced the severity of gout flares.

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.

Colchicine Tolerability

Colchicine 0.6 mg has been shown to be well tolerated1

In a 6-month study of patients with recurrent gout, the prophylactic use of colchicine was well tolerated. The most common adverse reactions experienced by patients taking colchicine once or twice daily are 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. 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® (colchicine).

Mitigare® Identification

A Pop of Color Sets Mitigare® Apart2-4

The distinctive two-tone blue capsules provide Mitigare® (colchicine) a pop of color to help patients differentiate this medication from others:2-4
A Pop of Color Sets Mitigare

  • 80 percent of 150 pharmacists surveyed believed visual similarities in pills contributed to trouble identifying medications3
  • The FDA advises that older adults who take more than one medicine should be able to tell them apart by size, shape, color, and form (tablet or capsule)4
  • The distinctive two-tone blue capsules provide a pop of color to help patients differentiate this medication from their other prescribed daily treatments3

Mit Pills Efficacy

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 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.
  3. White Paper — What Is the Significance of the Color of a Pill. Wallcur, LLC website. Available at: http://www.wallcur.com/whitepaper-pill-color.aspx . Accessed November 30, 2016.
  4. US Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors. US Food and Drug Administration website. Available at: http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm331810.pdf. Published December 2012. Accessed May 22, 2015.

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.