Colchicine

Colchicine is an alkaloid indicated for:

• Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).

1.2Familial Mediterranean Fever (FMF)

Colchicine tablets are indicated in adults and children four years or older for treatment of Familial Mediterranean Fever (FMF).

Patients with renal or hepatic impairment should not be given colchicine in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Patients with renal or hepatic impairment should not be given colchicine in conjunction with P-gp or strong CYP3A4 inhibitors (5.3).

In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses (7).

Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine 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 P-gp and/or CYP3A4 inhibitors : Co-administration of colchicine with P-gp and/or strong 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 colchicine ( 5.4 , 7 )

5.1Fatal Overdose

Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [ see Overdosage (10)]. Colchicine should be kept out of the reach of children.

5.2