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.
Monitor for 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
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
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.
References: 1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. Current through December 2020. Accessed December 7, 2020. 2. GLOPERBA [package insert]. Alpharetta, GA: Avion Pharmaceuticals, LLC; 2019.