• How can I help my patients save money on Mitigare®?

    Learn more about the Mitigare® True Blue Savings program for eligible patients.

  • What is the price of Mitigare® or colchicine 0.6 mg capsules (the authorized generic of Mitigare®)?

    For pricing information, please contact your nearest wholesaler or call West-Ward Pharmaceutical Corp. Customer Service at 1-800-631-2174.

  • Where can I order Mitigare® or colchicine 0.6 mg capsules (the authorized generic of Mitigare®)?

    Please contact your nearest wholesaler or call West-Ward Pharmaceutical Corp. Customer Service at 1-800-631-2174.

  • How should I write a prescription for Mitigare® 0.6 mg capsules?

    When you write “Mitigare®” or “colchicine 0.6 mg capsules” on the prescription, the pharmacist can dispense West-Ward’s colchicine 0.6 mg capsules. Prescriptions written this way provide the pharmacist with the opportunity to dispense West-Ward’s low-cost generic capsules—adding choice, accessibility and the potential to save money for your adult patients who take colchicine for prophylaxis of gout flares.

  • What should my patient do if he/she misses a dose of Mitigare®?

    If the patient misses a dose of colchicine 0.6 mg capsules, he/she should take the dose as soon as possible, and then return to the normal dosing schedule. However, if the patient skips a dose, the next dose should not be doubled. Please see the Medication Guide, available with the Full Prescribing Information for details.

  • For how long should my patient remain on Mitigare®?

    Per the ACR Guidelines, anti-inflammatory prophylaxis should continue for the greater of 2:

    • 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)
  • What is the appropriate dosage of Mitigare® for the prevention of gout flares in adults?

    For prophylaxis of gout flares in adults, the recommended dosage is 0.6 mg, taken once or twice daily. The maximum dose is 1.2 mg per day.

  • When should my patient begin prohphylaxis with Mitigare®?

    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).2

  • Which of my adult gout patients may benefit from Mitigare®?

    Mitigare® may help prevent flares in patients with 1:

    • 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)
  • How do I report negative side effects or adverse events?

    You are encouraged to report negative side effects of prescription drugs to the FDA. Please see full Prescribing Information.

  • How should Mitigare® be stored?

    Mitigare® 0.6 mg capsules should be stored at 20° to 25°C (68° to 77°F). Protect from light and moisture.

  • What is the FDA-approved indication for colchicine 0.6 mg capsules (the authorized generic of Mitigare®)?

    • Colchicine 0.6 mg capsules are indicated for prophylaxis of gout flares in adults.
    • The safety and effectiveness of colchicine 0.6 mg capsules for acute treatment of gout flares during prophylaxis has not been studied.
    • Colchicine 0.6 mg capsules are not an analgesic medication, and should not be used to treat pain from other causes.
  • What is the FDA-approved indication for Mitigare®?

    • 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.
  • Is Mitigare® FDA-approved?

    Yes. In September 2014, West-Ward’s affiliate, Hikma Pharmaceuticals LLC, obtained FDA approval for Mitigare®, the first approved colchicine 0.6 mg capsule for the prophylaxis of gout flares in adults. West-Ward’s colchicine 0.6 mg capsule is the generic version of Mitigare®.

  • What side effects are most commonly reported with Mitigare®?

    In a 6-month study of patients with recurrent gout, colchicine 0.6 mg was well tolerated.3 The most common adverse reactions were gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.3 Please see the Important Safety Information and Medication Guide for additional product safety information.


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References

  1. 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.
  2. 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.
  3. 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.

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.