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Important Safety Information for
LODOCO® (colchicine) 0.5 mg tablets

Do not take LODOCO if you:

• take certain medicines called strong CYP3A4 inhibitors or P-glycoprotein inhibitors. Ask your healthcare provider if you are not sure. Taking certain medicines with LODOCO may cause your level of LODOCO to be too high in your body and cause life-threatening side effects or death.
• have severe kidney or liver problems.
• have blood problems.
• are allergic to colchicine or any of the ingredients in LODOCO.

What are the possible side effects of LODOCO?

LODOCO may cause serious side effects, including:

• Blood problems. LODOCO can cause low red blood cell counts, low white blood cell counts, and low platelet counts, which can be life-threatening or may lead to death.
• Muscle weakness (neuromuscular toxicity). LODOCO can cause muscle weakness and muscle problems.

The most common side effects of LODOCO include:

• • diarrhea, vomiting, and stomach-area (abdominal) cramping.

• • muscle pain

Fatal overdoses have been reported with colchicine in adults and children. Keep LODOCO out of the reach of children.

INDICATION

LODOCO is indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Please see Full Prescribing Information.

*The absolute risk was found to be 6.8% in the colchicine group and 9.6% in the placebo group, with an absolute risk reduction of 2.8%.

References: 1. Nidorf SM, Fiolet ATL, Mosterd A, et al. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020;383(19):1838-1847. doi:10.1056/NEJMoa2021372