• 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.

  • 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. Today, Hikma’s colchicine 0.6 mg capsule is the generic version of Mitigare®.

  • How can I save money on Mitigare®?

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

  • 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.

  • What should I do if I miss a dose of Mitigare®?

    If you miss a dose of Mitigare® (colchicine) 0.6 mg Capsules, take the dose as soon as possible, and then return to the normal dosing schedule. However, if you skip a dose, the next dose should not be doubled. Please see the Medication Guide, available with the Full Prescribing Information for details.

  • What should I do if I have a gout flare while taking Mitigare®?

    If you have a gout flare while taking Mitigare®, be sure to tell your doctor as soon as possible.

  • For how long should I take Mitigare®?

    Do not stop taking Mitigare® unless your healthcare provider tells you to.

  • Should I avoid any foods or beverages while I’m taking Mitigare®?

    Avoid eating grapefruit or drinking grapefruit juice while taking Mitigare®. Doing so can increase your chances of very serious side effects. Deaths have been reported. Please see the Medication Guide, available with the Full Prescribing Information for details.

  • How should I take Mitigare®?

    • Take Mitigare® exactly as your doctor tells you to take it. For most adult patients, Mitigare® (colchicine) 0.6 mg Capsules are taken once or twice daily.
    • Mitigare® can be taken with or without food. However, grapefruit and grapefruit juice can cause a toxic reaction when consumed with Mitigare®. 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.
  • When should I begin treatment with Mitigare®?

    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).2 Talk to your doctor about whether starting colchicine 0.6 mg capsules may be right for you.

  • Where can I get additional information on Hikma’s colchicine 0.6 mg capsules?

    Please see full Prescribing Information. You can also refer to the Medication Guide.

  • What Important Safety Information should I know about Mitigare® (colchicine) 0.6 mg Capsules?

    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 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 colchicine capsules.
    • Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine capsules 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 colchicine capsules.
    • The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.
    • Please see full Prescribing Information. You can also refer to the Medication Guide.

 

Go To ALL FAQS

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 Columbus Inc., Columbus, OH 43228

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.