COLCRYS Efficacy and Safety Profiles

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.

In a randomized, prospective, double-blind, placebo-controlled study1

Colchicine with ULT for 6 months decreased the frequency of gout flares1,2

33% of patients on colchicine had acute flares over 6 months vs 77% on placebo (p=0.008)1*

Study design: Forty-three patients starting allopurinol were randomized to receive colchicine 0.6 mg twice a day or placebo in a randomized, prospective, double-blind, placebo-controlled trial. Allopurinol was initiated at 100 mg daily, and the dose increased in 100-mg increments until a serum urate level <6.5 mg/dL was attained (mean dose in the colchicine group, 265 mg daily; mean dose in the placebo group, 245 mg daily). The average baseline serum urate levels were 9.49 mg/dL in the colchicine group vs 9.15 mg/dL in the placebo group.1

ULT=urate-lowering therapy.
*Multiple gout flares occurred in 14% of patients taking colchicine and 63% of patients taking placebo (p=0.004).1
12 flares/21 patients.1
65 flares/22 patients.1

Initiating ULT may cause gout flares2

  • An increase in gout flares may occur after initiation of ULT, including pegloticase, febuxostat, and allopurinol, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits2-4

  • COLCRYS is recommended upon initiation of ULT. Prophylactic therapy may be beneficial for at least the first six months of ULT2-4

Management of acute gout flares during prophylactic treatment

  • For treatment of gout flares during prophylaxis, COLCRYS may be administered at doses not to exceed 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later. Wait 12 hours and then resume the prophylactic dose2

  • The maximum recommended dose of COLCRYS for treatment of gout flares is 1.8 mg over a 1-hour period2

  • ULT need not be discontinued during a gout attack3,5

COLCRYS does not treat hyperuricemia.2

COLCRYS has not been shown to prevent chronic joint destruction and tissue deformities, and effects on tophi have not been established.2

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 hours2,6

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

Help prepare patients with COLCRYS

Help patients prepare for the flare with COLCRYS on hand.

Help patients save on COLCRYS

Eligible patients may pay only $15 for COLCRYS.

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. 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.

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

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

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

  5. 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.

  6. 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.

Important Safety Information

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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.