3 Things You Should Know About Generic Colchicine 0.6 mg Capsules

By: | | Topics : About Gout, Colchicine, Mitigare,

Generic Colchicine 0.6 mg capsules

Colchicine is a medicine used to help prevent gout flares in adults.1 Gout is a form of inflammatory arthritis that occurs when too much uric acid builds up in the joints, leading to chronic swelling and often intense pain.2,3

There are several stages of gout. The most serious involves frequent gout flares, which develop in people whose uric acid levels have been high for many years.4 Once infrequent, flares begin to occur regularly, and the pain increases in severity and duration.4 Joint damage may also occur, which can lead to loss of mobility.4

 

What you should know about colchicine

If you suffer with gout flares, here are three important things to know about colchicine 0.6 mg capsules:

1. Colchicine has been used for centuries to prevent gout attacks5

Colchicine was originally derived from a plant called the autumn crocus (Colchicum autumnale).5 The drug was prescribed for gout flare prevention for many years before manufacturers were required to have formal approval from the U.S. Food and Drug Administration (FDA).6 Until this time, patients had grown accustomed to paying approximately 10 cents a pill for this daily medication.6

2. Colchicine, a once-affordable drug, became too costly for many patients6

In 2009, the FDA approved the first branded version of colchicine.6 All other formulations, which had not gone through FDA’s review process, were removed from the market at that time.6 Patients who tried to refill their prescriptions found that their long-used colchicine medications were no longer available.6

The only colchicine option at this time was a newly branded drug offered by a pharmaceutical company that charged $5 per pill—50 times the price of colchicine pills previously available.6

In response, West-Ward Pharmaceuticals Corp. pursued the development of a colchicine capsule product and secured FDA approval for and introduced Mitigare® (colchicine) 0.6 mg Capsules in 2014.7 The company began offering their authorized generic, colchicine 0.6 mg capsules, shortly thereafter.7 West-Ward was the first manufacturer to provide an authorized generic, offering significant potential savings for patients.7

As of today, West-Ward remains the only manufacturer offering colchicine therapy in capsule form.

3. Color matters

Mitigare® (colchicine) 0.6 mg Capsules, and its authorized generic, colchicine 0.6 mg capsules, are a distinctive two-tone blue color. This pop of color may help adult patients distinguish these capsules from other medications they take.8,9 

The True Blue Savings program helps qualified patients save money on their Mitigare® prescriptions. With the Mitigare® True Blue Savings Card, eligible patients can receive Mitigare® (colchicine) free for 30 days and get $5 refills.*

*For all eligible patients 18 years or older who are legal residents of the United States or Puerto Rico. First 30 days are free only for eligible patients. Maximum savings of $65 on the first fill and $50 on refills. Please see complete Terms and Conditions available at Mitigare.com.

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.

 

Important Safety Information

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 one of these dual inhibitors, or a medication that inhibits either P-gp or CYP3A4, with colchicine has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not use Mitigare®. The safety and effectivenes 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.

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 use. Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.

Please see full Prescribing Information and Medication Guide for Mitigare® for complete product details.

NOTE: This article was not written by a medical professional and is not intended to substitute the guidance of a physician. These are not West-Ward’s recommendations for gout flare prevention, but rather facts and data collected from various reliable medical sources. For a list of resources and their attributing links, see below.

References

  1. Borstad GC, Bryant LR, Abel MP, et al. Colchicine prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004 Dec;31(12):2429–32.
  2. Zhu Y et al. Prevalence of Gout and Hyperuricemia in the US General Population. The National Health and Nutrition Examination Survey 2007–2008. Arthritis Rheum. 2011;63(10):3136–3141.
  3. US National Library of Medicine. PubMed Health. Gout: Overview. https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0073025/. Accessed November 21, 2017.
  4. Arthritis Foundati hron. What is Gout? http://www.arthritis.org/about-arthritis/types/gout/what-is-gout.php. Accessed November 21, 2017.
  5. Nuki G, Simkin PA. A concise history of gout and hyperuricemia and their treatment. Arthritis Res Ther. 2006;8(Suppl 1):S1.
  6. Kesselheim AS, et al. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population. J Gen Intern Med. 2015 Nov;30(11):1633–1638.
  7. Court allows generic colchicine to enter market. Rheumatology News. January 28, 2015. http://www.mdedge.com/familypracticenews/article/96726/rheumatology/court-allows-generic-colchicine-enter-market. Accessed November 21, 2017.
  8. White Paper—What Is the Significance of the Color of a Pill. Wallcur, LLC website. http://www.wallcur.com/whitepaper-pill-color.aspx. Accessed November 21, 2017.
  9. US Food and Drug Administration. Medicines and You: A Guide for Older Adults. https://www.fda.gov/Drugs/ResourcesForYou/ucm163959.htm. Published April 2016. Accessed November 21, 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

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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.