Although the majority of people who suffer with gout are men, many women are affected by the disease.1

 

Gout Patient Profiles: Although the majority of people who suffer with gout are men, many women are affected by the disease.

Common Comorbidities

People with gout often have other medical conditions3:

  • Obesity
  • Metabolic syndrome
  • Diabetes Mellitus
  • Hypertension
  • Hyperlipidemia
  • Heart failure (CHF)

Notable Differences

Gout may present differently in male and female patients.4 Notable Differences: Gout may present differently in male and female patients.

The table above was created by Hikma Pharmaceuticals USA based on data from a systematic review of the clinical features of men and women with gout. The aim of the review was to evaluate the available studies on the sex differences in clinical features of gout. Nine articles were selected for inclusion in the review.

Adults Who May Benefit From Mitigare®

Mitigare® (colchicine) may be appropriate for patients with5:

  • Established diagnosis of gout
  • Serum urate >5 mg/dL
  • Clinical or radiographic evidence of tophus or tophi
  • >2 acute attacks of gout in the previous year
  • Possible past history of renal stone(s) (urolithiasis)

Mitigare® may not be right for all adult patients and is 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.® Please see full Prescribing Information and Medication Guide for complete product information.

References

  1. 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.
  2. Arthritis/Gout. Centers for Disease Control and Prevention website. Available at: http://www.cdc.gov/arthritis/basics/gout.html. Accessed November 30, 2016.
  3. Gow P. Treating gout in patients with comorbidities. Int J Clin Rheumatol. 2011;6(6):625-633.
  4. 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.
  5. Khanna D, Fitzgerald JD, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 1: Systematic Nonpharmacologic and Pharmacologic Therapeutic Approaches to Hyperuricemia. Arthritis Care Res (Hoboken). Oct 2012;64(10):1431-1446.

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.