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.

The American College of Rheumatology guidelines for management of gout1

Recommendations
  • Recommendations include COLCRYS as an appropriate first-line treatment option for acute gout attacks when taken at the first sign of a flare

  • Recommendations include the use of a prophylactic agent for gout patients when initiating ULT

    • Anti-inflammatory prophylaxis should continue from initiation of ULT for the greater of at least 6 months or, following achievement of target serum urate, for 3 months in patients without tophi, or 6 months in patients with tophi on physical exam

  • Recommendations also include COLCRYS as an appropriate first-line treatment option for gout flare prophylaxis during initiation of ULT

Help reduce gout attack pain at 24 hours2,3

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

Help decrease gout flare frequency2,4

Flare prevention therapy may be beneficial for the first 6 months of ULT.2,5,6

Help prepare patients with COLCRYS

Help patients prepare for the flare with COLCRYS on hand.

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. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 2: Therapy and anti-inflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res. 2012;64(10):1447-1461.

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

  3. 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.

  4. 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.

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

  6. 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.