• MITIGARE™ is indicated for prophylaxis of gout flares in adults (1).

Limitations of use:
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.
DOSAGE AND ADMINISTRATION

• 0.6 mg (one capsule) once or twice daily (2).Maximum dose 1.2 mg/day.

MITIGARE™ is administered orally, without regard to meals (2).

• Fatal overdoses have been reported with colchicine in adults and children. Keep MITIGARE™ out of the reach of children (5.1, 10).
• Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported (5.2).

• Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine (5.2, 5.3, 5.4, 6, 10).

• 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 (5.3, 7).
• Neuromuscular toxicity: Myotoxicity including rhabdomyolysis may occur, especially in combination with other drugs known to cause this effect. Consider temporary interruption or discontinuation of MITIGARE™ (5.4, 7).

The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain (6).

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Americas, Inc. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
 DRUG INTERACTIONS

• Co-administration of P-gp or CYP3A4 inhibitors or inhibitors of both P-gp and CYP3A4 (e.g., clarithromycin or cyclosporine) have been reported to lead to colchicine toxicity. The potential for drug-drug interactions must be considered prior to and during therapy.
• Concomitant use of MITIGARE™ and inhibitors of CYP3A4 or P-gp should be avoided if possible. If co-administration of MITIGARE™ and an inhibitor of CYP3A4 or P-gp is necessary, the dose of MITIGARE™ should be reduced and the patient should be monitored carefully for colchicine toxicity (7, 12.3).
 

• In the presence of renal or hepatic impairment, patients should be monitored closely and dose adjustment should be considered as necessary (8.6, 8.7).
• Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus (8.1).
• Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3).
• Geriatric Use: The recommended dose of colchicine should be based on renal/hepatic function (8.5).