We’ve changed our name but not our commitment to you. Although our name is changing, we have the same commitment to meeting today’s healthcare needs with quality products and customer-first service.

Facts related to name change

  • While our US name is changing, our commitment to our state of the art US manufacturing, robust R&D investments and the US market, customer’s partners and patients, remains as strong as ever.
  • Our NDCs will not change.
  • Our Ordering processes will remain the same.
  • We will continue with the same strong portfolio of products.
  • Our updated product packaging and labeling will be rolled out over the next 12-18 months, with the focus on maintaining consistent supply and patient access.

Committed to supplying the medicines patients need

Our commitment to provide a reliable supply of quality pharmaceuticals starts with a patient-first approach. We forego efficiencies by holding excess inventory to protect our patients from medication shortages. We are committed to expanding our portfolio of pharmaceutical products through acquisition and process innovation.

Committed to providing affordable treatment

Ensuring that affordable gout flare prevention is available to those who need it is extremely important to us. We introduced the first and only other branded colchicine product for prevention of gout flares in adults in 2014 and still offer it at a low price. We also offer an authorized generic colchicine product as an alternative to the branded medication.

Visit Hikma Pharmaceuticals USA Inc. online to learn more.

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.