Prophylaxis—A Key to Adult Gout Flare Prevention

It’s True. It’s Blue.

Mitigare® (colchicine) and its authorized generic colchicine 0.6 mg capsules may help make gout flare prevention more affordable for your adult patients.1-3 Mitigare® capsules have a distinctive color to help adults prevent gout flares.1-3 The distinctive two-tone capsule may help patients identify their medication.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.

Where to Begin

Anti-inflammatory prophylaxis—before ULT6

The American College of Rheumatology (ACR) Guidelines for Management of Gout state that patients should begin anti-inflammatory prophylaxis prior to or concurrent with urate-lowering therapy (ULT).6

  • The ACR Task Force Panel recommends low-dose colchicine (0.5 mg to 0.6 mg orally once or twice a day) as a first-line option.
  • The goal of long-term gout management is to reduce the urate level below the limit of monosodium urate (MSU) solubility, thus dissolving MSU crystals.2
  • The dispersion of MSU crystals puts the patient at increased risk of gout flares.7

 

Flare prophylaxis should continue for at least 3 to 6 months6

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

  • At least 6 months OR
  • 3 months after achieving target serum urate appropriate for the patient (no tophi detected on physical exam).
  • 6 months after achieving target serum urate appropriate for the patient (one or more tophi detected on physical exam).

 

Untreated hyperuricemia advances the severity of gout8

Over time, untreated chronic hyperuricemia can increase body urate stores, advancing the severity of the disease.

  • In a study of colchicine prophylaxis in 208 patients with acute gouty arthritis, 62% of patients experienced their second acute flare within 1 year of their first gout flare.2

 

Flare prophylaxis is recommended with urate-lowering therapy (ULT)9-11

The ACR Guidelines for Management of Gout state that patients should begin anti-inflammatory prophylaxis prior to or concurrent with ULT.1 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.

Gout flare prevention begins with treatment.

Prescribing Information Recommendation

Uloric® (febuxostat)9 “Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of Uloric®. Prophylactic therapy may be beneficial for up to six months…”
Zurampic® (lesinurad)10 “Gout flare prophylaxis is recommended when starting Zurampic®, according to practice guidelines.”
Krystexxa® (pegloticase)11 “Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of Krystexxa® therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.”

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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.
  7. Latourte A, Bardin T, Richette P. Prophylaxis for acute gout flares after initiation of urate-lowering therapy. Rheumatology. 2014;53:1920-1926.
  8. Edwards NL. Clinical gout. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH. Rheumatology. Vol 2. 6th ed. Philadelphia, Pa: Mosby/Elsevier Ltd; 2015:1569.
  9. Uloric (febuxostat) Full Prescribing Information.
  10. ZURAMPIC® (lesinurad) Full Prescribing Information.
  11. KRYSTEXXA® (pegloticase) Full Prescribing Information.
  12. Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the US general population: the NationalHealth and Nutrition Examination Survey 2007-2008. Arthritis Rheum 2011; 63: 3136-3141.
  13. Arthritis/Gout. Centers for Disease Control and Prevention website. Available at: http://www.cdc.gov/arthritis/basics/gout.html. Accessed November 30, 2016.

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.