Gout Flare Prevention

For Patients Starting ULT, Care Comes in a Capsule.

Although allopurinol (urate-lowering therapy; ULT) is a key component of gout management, its use can be associated with an increase in the number of gout flares.1

 

Hyperuricemia (elevated uric acid in blood) develops

When the serum urate level in the bloodstream remains elevated for extended periods, joints become susceptible to monosodium urate (MSU) crystal deposition.1

Monosodium Urate (MSU) crystals form in joints and tissue

Allopurinol is prescribed to help reduce the serum urate level in the bloodstream.2

This reduction in the serum urate level can disturb the MSU crystals in a joint.1

MSU crystals dissolve and migrate into joint space

The disturbance of the MSU crystals can trigger a gout flare.1

Colchicine can inhibit the neutrophil response and possibly prevent the flare.3

Gout flare occurs

The pain during a flare can be so intense, many gout sufferers visit the emergency room seeking relief.4

Flares may be prevented with colchicine prophylaxis.5

Mitigare® Can Help Prevent Gout Flares in Adults Starting Allopurinol1,5

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).5 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.5

Per the ACR Guidelines, anti-inflammatory prophylaxis should continue for the greater of5:

  • 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)

Prescribing Information Recommendation

Gout flare prophylaxis is recommended prior to and during treatment with allopurinol and other ULTs.2,6

allopurinol2 “…maintenance doses of colchicine generally should be given prophylactically when allopurinol is begun. The use of colchicine or other anti-inflammatory agents may be required to suppress gouty attacks in some cases.”
Uloric® (febuxostat)6 “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…”

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

Uloric® is a trademark of Teljin Limited registered with the US Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

Who are potential Mitigare® patients?

Tips for Adult Gout Patients Your patients may benefit from information on how to prevent their gout flares. Share our Gout Blog with them for a variety of healthy living tips and advice.

Tips for Adult Gout Patients

Your patients may benefit from information on how to prevent their gout flares. Share our Gout Blog with them for a variety of healthy living tips and advice.

GOUT BLOG

References

  1. Aung T, Myung G, FitzGerald JD. Treatment approaches and adherence to urate-lowering therapy for patients with gout. Patient Prefer Adherence. 2017;11:795-800
  2. Allopurinol Tablets, USP [prescribing information]. Memphis, TN: Northstar Healthcare Holdings; 2016.
  3. Latourte A, Bardin T, Richette P. Prophylaxis for acute gout flares after initiation of urate-lowering therapy. Rheumatology. 2014;53:1920-1926.
  4. Emergency Department Gout Visits Rise Dramatically. Renal & Urology News. Available at: https://renalandurologynews.com/home/news/ nephrology/hyperuricemia/emergency-departmentgout- visits-rise-dramatically/. Accessed February 10, 2020.
  5. 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.
  6. Uloric® (febuxostat) [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Incl; 2013.
  7. Chen-Xu M, et al. Contemporary Prevalence of Gout and Hyperuricemia in the United States and Decadal Trends: The National Health and Nutrition Examination Survey, 2007-2016. Arthritis Rheumatol. 2019 June;71(6):991-999.

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

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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.