Gout in Women: Not Just a Men’s Disease

Gout is a painful type of inflammatory arthritis that affects more than 8 million people in the US.1 Nearly three times as many men as women have gout.1 However, the Read more...

What Is the Difference Between Gout and Gout Flares?

More than 8 million Americans suffer with gout.1 But many don’t know they have gout because they haven’t experienced gout flares. It’s important to understand the difference between gout and gout Read more...

The Four Stages of Gout: What Could Happen if I Don’t Manage My Gout

If you’ve ever had a gout flare, you know one thing for sure—you never want it to happen again. Flares can occur suddenly, often in the middle of the night.1 Read more...

How Is Gout Diagnosed in Adults?

Gout is the most common form of inflammatory arthritis, affecting more than one percent of the population.1 However, it can be difficult to accurately diagnose because its symptoms can be Read more...

What is Gout?

Gout is a painful form of inflammatory arthritis.1 Approximately 8.3 million Americans live with this disease.1 Gout usually appears first in the big toe, but can also affect the midfoot, Read more...

Top Signs You May Want to See a Doctor for Gout

People with gout, a painful form of inflammatory arthritis, sometimes have an initial occurrence, followed by a long period of time when the gout is in remittance before it flares again.  Read more...

What Happens to Your Body When You Have Gout?

A frequently asked question is: “What happens to your body when you have gout?” Gout is a type of arthritis. It is caused by the buildup of uric acid crystals Read more...

What You Need to Know After Being Diagnosed with Gout

The big toe often is where gout attacks first. Gout attacks also can occur in the heels, instep, ankles, knees, elbows, hips, thumbs, and fingers. Symptoms of gout include intense Read more...

Menopause and Gout: What You Need to Know

Gout, a painful form of inflammatory arthritis, has been in existence since ancient times.1 With its painful swelling and redness, gout often occurs in the big toe and may show up Read more...

Mitigare® for the Prevention of Gout Flares in Adults: What You Need to Know

Gout is a painful form of inflammatory arthritis1 caused by a condition called hyperuricemia. Hyperuricemia happens when there is too much uric acid in the body. When there is too much uric Read more...

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.