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 multicenter, randomized, double-blind, 1-week, dose-comparison study1

GI adverse events in acute gout treatment: COLCRYS (1.8-mg dosing) compared to placebo1*

Adverse reactions occurring in ≥2% of acute gout flare patients1

  • GI adverse reactions occurred in 26% of patients on 1.8-mg COLCRYS* compared to 77% of patients on nonrecommended 4.8-mg high-dose colchicine and 20% of patients on placebo
  • Diarrhea was the most commonly reported drug-related gastrointestinal adverse event. Diarrhea is associated with COLCRYS* treatment. Diarrhea was more likely to occur in patients taking the high-dose regimen (77%) than the COLCRYS 1.8-mg regimen. Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the nonrecommended high-dose colchicine regimen but did not occur in the recommended COLCRYS 1.8-mg regimen. Abdominal discomfort occurred in 0% and nausea occurred in 17% of patients taking high-dose colchicine
  • The most common adverse reactions reported in the clinical trial with COLCRYS for treatment of gout flares that were greater than placebo were diarrhea (23%) and pharyngolaryngeal pain (3%)1

Study design: In a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 1-week, dose-comparison study, patients were randomly assigned to 3 groups: high-dose colchicine (1.2 mg, then 0.6 mg hourly x 6 hours [4.8 mg total]), low-dose colchicine (1.2 mg, then 0.6 mg in 1 hour [1.8 mg total] followed by 5 placebo doses hourly), or placebo (2 capsules, then 1 capsule hourly x 6 hours). Patients took the first dose within 12 hours of the onset of the flare and recorded pain intensity (11-point Likert scale) and adverse events over 72 hours. The efficacy of colchicine was measured based on response to treatment in the target joint, using patient self-assessment of pain at 24 hours following the time of first dose as recorded in the diary.1,2

GI=gastrointestinal.
*COLCRYS given as two 0.6-mg tablets, followed by one 0.6-mg tablet 1 hour later.1
†High-dose colchicine given as two 0.6-mg tablets, then one 0.6-mg tablet hourly x 6 hours.1

Next: Dosing

Help reduce gout attack pain at 24 hours1,2

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

  2. 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.