It’s True. Mitigare® and its authorized generic colchicine 0.6 mg capsules may help make flare prevention affordable for adults with gout.1-3

It’s True. When your doctor prescribes Mitigare® (colchicine), your pharmacist can dispense its authorized generic, which may help you save money.

It’s True. The Mitigare® True Blue Savings program may help you save even more.

It’s True. Colchicine has been used for gout flare prevention for hundreds of years.

It’s True. West-Ward Pharmaceuticals launched the first authorized generic 0.6 mg colchicine capsules.

Learn About Mitigare®

It’s Blue. Mitigare® is the only gout flare prevention therapy with a pop of blue color, helping it to stand out from other medications.4,5

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.

Better Together

Urate-lowering therapy and Mitigare® (colchicine)

The American College of Rheumatology (ACR) Guidelines for Management of Gout state that patients should begin taking an anti-inflammatory medicine such as colchicine either right before or when starting treatment with a urate-lowering therapy (ULT).6

Some commonly prescribed ULTs include:

  • Uloric® (febuxostat)
  • Zurampic® (lesinurad)
  • Krystexxa® (pegloticase)

These therapies may not be appropriate for all adult patients; the full Prescribing Information, including contraindications, warnings, precautions, and other dosing considerations should always be consulted.

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Recommended Dosing

Mitigare® is the only colchicine product for the prevention of gout flares in adults that is available in a capsule. For most adult patients, Mitigare® (colchicine) 0.6 mg capsules are taken once or twice daily. Your doctor will tell you how much to take. Always take Mitigare® exactly as directed.

Mitigare® may be taken with or without food. Grapefruit and grapefruit juice can cause a toxic reaction when consumed with Mitigare®. It can cause the level of colchicine in your blood to increase. Deaths have been reported.

If you miss a dose of Mitigare®, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.

If you take too much Mitigare®, call your doctor or immediately go to the nearest hospital emergency room. Fatal overdoses of Mitigare® have been reported.

Duration of Therapy

Per the ACR Guidelines, anti-inflammatory prophylaxis should continue for the greater of6:

  • At least 6 months OR
  • 3 months after achieving target serum urate appropriate for the patient (no tophi, or small white or yellow lumps under the skin, detected on physical exam)
  • 6 months after achieving target serum urate appropriate for the patient (one or more tophi detected on physical exam)

Knowing the medications you take is extremely important when taking Mitigare® (colchicine). Keep a list of your medications with you to show your doctor or pharmacist each time you are prescribed a new medication.

See your doctor regularly while you are taking Mitigare®. Tell him or her right away if you have any unusual side effects. Do not stop taking Mitigare® unless your doctor tells you to do so.

How to Store Mitigare®

Mitigare® (colchicine) should be stored:

  • At room temperature, between 68 and 77 degrees F (20 and 25 degrees C)
  • In a tightly closed container
  • Away from light
  • Out of the reach of children

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. PriceRx for Wholesalers. Wolters Kluwer website. Available at: http://www.wolterskluwercdi.com/wholesalers-pricerx/. Accessed November 30, 2016.
  4. 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.
  5. 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.
  6. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 2: Therapy and Antiinflammatory Prophylaxis of Acute Gouty Arthritis. Arthritis Care Res (Hoboken). 2012;64:1447-1451 and 1456-1459.

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.