About COLCRYS

INDICATIONS

COLCRYS is indicated in adults for the prophylaxis of gout flares and treatment of acute gout flares when taken at the first sign of a flare.

COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.

COLCRYS may interfere with gout’s inflammatory cascade1

    COLCRYS potentially interferes with the inflammasome complex, which mediates IL-1β activation1

  • Prevents the activation, degranulation, and migration of neutrophils thought to mediate gout pain


The effects described below have been proposed as the potential mechanism of action for colchicine in gout.

See the Dosage and Administration section of the complete Prescribing Information for all dosing information, including adjustments and potential drug interactions.

Help reduce gout attack pain at 24 hours1,10

Taken at the first sign, COLCRYS reduced the pain of acute gout attacks.

Help decrease gout flare frequency1,11

Flare prevention therapy may be beneficial for the first 6 months of ULT.1,12,13

Consider comorbidities

COLCRYS has dosing recommendations, including gout patients with renal impairment.1

ULT=urate‐lowering therapy.

IMPORTANT SAFETY INFORMATION

  • COLCRYS is contraindicated in patients with renal or hepatic impairment who are currently prescribed P-gp inhibitors or strong inhibitors of CYP3A4. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors in patients with normal renal and hepatic function.

  • Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children.

  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported in patients taking colchicine at therapeutic doses.

  • Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk.

  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.

  • The most common adverse reactions in clinical trials were diarrhea (23%) and pharyngolaryngeal pain (3%).

INDICATIONS

COLCRYS (colchicine, USP) 0.6 mg tablets are indicated in adults for the prophylaxis of gout flares and treatment of acute gout flares when taken at the first sign of a flare.

COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.

Please see the complete Prescribing Information and Medication Guide.

References:

  1. COLCRYS (colchicine, USP) prescribing information. Takeda Pharmaceuticals.

  2. Neogi T. Clinical practice. Gout. N Engl J Med. 2011;364:443-452.

  3. Busso N, So A. Mechanisms of inflammation in gout. Arthritis Res Ther. 2010;12:206.

  4. Rose DM, Liu-Bryan R. Innate immunity in triggering and resolution of acute gouty inflammation. Curr Rheumatol Rep. 2006;8:209-214.

  5. Liu-Bryan R, Scott P, Sydlaske A, Rose DM, Terkeltaub R. lnnate immunity conferred by Toll-like receptors 2 and 4 and myeloid differentiation factor 88 expression is pivotal to monosodium urate monohydrate crystal-induced inflammation. Arthritis Rheum. 2005;52:2936-2946.

  6. Cronstein BN, Terkeltaub R. The inflammatory process of gout and its treatment. Arthritis Res Ther. 2006;8(suppl1 ):S3.

  7. Phelps P. Polymorphonuclear leukocyte motility in vitro. IV. Colchicine inhibition of chemotactic activity formation after phagocytosis of urate crystals. Arthritis Rheum. 1970;13:1-9.

  8. Pope RM, Tschopp J. The role of interleukin-1 and the inflammasome in gout: implications for therapy. Arthritis Rheum. 2007;56:3183-3188.

  9. Keenan RT, Nowatzky J, Pillinger MH. Etiology and pathogenesis of hyperuricemia and gout. In: Firestein GS, Budd RC, Gabriel SE, McInnes IB, O'Dell JR, eds. Kelley's Textbook of Rheumatology. Vol 2. 9th ed. Philadelphia, PA: Saunders Elsevier; 2013:1533-1553.

  10. Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High versus low dosing of oral colchicine for early acute gout flare: twenty-four–hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. Arthritis Rheum. 2010;62(4):1060-1068.

  11. Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD, Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004;31:2429-2432.

  12. ULORIC (febuxostat) prescribing information. Takeda Pharmaceuticals.

  13. Allopurinol prescribing information. Mutual Pharmaceutical Company, Inc. October 2009.

Important Safety Information

Expand

IMPORTANT SAFETY INFORMATION

  • COLCRYS is contraindicated in patients with renal or hepatic impairment who are currently prescribed P-gp inhibitors or strong inhibitors of CYP3A4. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors in patients with normal renal and hepatic function.

  • Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children.

  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported in patients taking colchicine at therapeutic doses.

  • Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk.

  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.

  • The most common adverse reactions in clinical trials were diarrhea (23%) and pharyngolaryngeal pain (3%).

INDICATIONS

COLCRYS (colchicine, USP) 0.6 mg tablets are indicated in adults for the prophylaxis of gout flares and treatment of acute gout flares when taken at the first sign of a flare.

COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.

Please see the complete Prescribing Information and Medication Guide.