IMPORTANT SAFETY INFORMATION
Important Safety Information for GLOPERBA® (colchicine)
- Colchicine 0.6 mg oral solution is 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 GLOPERBA.
- Fatal overdoses have been reported with colchicine in adults and children. Keep GLOPERBA 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.
- Drug interactions: Concomitant use of GLOPERBA with inhibitors of both CYP3A4 and P-gp should be avoided. If treatment with colchicine is necessary, a reduced daily dose should be considered and the patient should be closely monitored for colchicine toxicity and, if present, consider lowering the dose, temporary interruption, or discontinuation of colchicine.
- 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 lowering the dose, temporary interruption, or discontinuation of GLOPERBA.
- The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.
Indication
GLOPERBA 0.6 mg oral solution is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.
You are encouraged to report negative side effects of prescription drugs to the FDA.
To report suspected adverse reactions, visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for GLOPERBA.