Colcrys
COLCRYS- colchicine tablet, film coated
Aphena Pharma Solutions — Tennessee, LLC
1 INDICATIONS AND USAGE
1.1 Gout Flares
COLCRYS® (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.
- Prophylaxis of Gout Flares:
COLCRYS is indicated for prophylaxis of gout flares. - Treatment of Gout Flares: COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2 Familial Mediterranean fever (FMF)
COLCRYS® (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF).
2 DOSAGE AND ADMINISTRATION
The long term use of colchicine is established for FMF and the prophylaxis of gout flares but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for COLCRYS are different for each indication and must be individualized.
The recommended dosage of COLCRYS depends on the patient’s age, renal function, hepatic function, and use of co-administered drugs [see Dose Modification for Co-administration of Interacting Drugs (2.4) ].
COLCRYS tablets are administered orally, without regard to meals.
COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.
2.1 Gout Flares
Prophylaxis of Gout Flares:
The recommended dosage of COLCRYS for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day.
Treatment of Gout Flares:
The recommended dose of COLCRYS for treatment of a gout flare is 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a 1 hour period. COLCRYS may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Wait 12 hours and then resume the prophylactic dose.
2.2 FMF
The recommended dosage of COLCRYS for FMF in adults is 1.2 mg to 2.4 mg daily.
COLCRYS should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily COLCRYS dose may be administered in one to two divided doses.
2.3 Recommended Pediatric Dosage
Prophylaxis and Treatment of Gout Flares:
COLCRYS is not recommended for pediatric use in prophylaxis or treatment of gout flares.
FMF:
The recommended dosage of COLCRYS for FMF in pediatric patients 4 years of age and older is based on age. The following daily doses may be given as a single or divided dose twice daily:
- •
- Children 4 – 6 years: 0.3 mg to 1.8 mg daily
- •
- Children 6 – 12 years: 0.9 mg to 1.8 mg daily
- •
- Adolescents older than 12 years: 1.2 mg to 2.4 mg daily
2.4 Dose Modification for Co-administration of Interacting Drugs
Concomitant Therapy:
Co-administration of COLCRYS with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1). If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown on the table below [see DRUG INTERACTIONS (7) ].
| |||||||
Strong CYP3A4 Inhibitors † | |||||||
Drug | Noted or Anticipated Outcome | Gout Flares | FMF | ||||
Prophylaxis of Gout Flares | Treatment of Gout Flares | Original Intended Dosage | Adjusted Dose | ||||
Original Intended Dosage | Adjusted Dose | Original Intended Dosage | Adjusted Dose | ||||
AtazanavirClarithromycinDarunavir/Ritonavir ‡IndinavirItraconazole KetoconazoleLopinavir/Ritonavir ‡NefazodoneNelfinavirRitonavirSaquinavir TelithromycinTipranavir/Ritonavir ‡ | Significant increase in colchicine plasma levels *; fatal colchicine toxicity has been reported with clarithromycin, a strong CYP3A4 inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other strong CYP3A4 inhibitors. | 0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | 1.2 mg(2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | 0.6 mg(1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 1.2 – 2.4 mg | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
Moderate CYP3A4 Inhibitors | |||||||
Drug | Noted or Anticipated Outcome | Gout Flares | FMF | ||||
Prophylaxis of Gout Flares | Treatment of Gout Flares | Original Intended Dosage | Adjusted Dose | ||||
Original Intended Dosage | Adjusted Dose | Original Intended Dosage | Adjusted Dose | ||||
Amprenavir ‡ AprepitantDiltiazem Erythromycin Fluconazole Fosamprenavir ‡(pro-drug ofAmprenavir)Grapefruit JuiceVerapamil | Significant increase in colchicine plasma concentration is anticipated. Neuromuscular toxicity has been reported with diltiazem and verapamil interactions. | 0.6 mg twice a day0.6 mg once a day | 0.3 mg twice a day or 0.6 mg once a day0.3 mg once a day | 1.2 mg(2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | 1.2 mg(2 tablets) × 1 dose. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 1.2 – 2.4 mg. | Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day) |
P-gp Inhibitors † | |||||||
Drug | Noted or Anticipated Outcome | Gout Flares | FMF | ||||
Prophylaxis of Gout Flares | Treatment of Gout Flares | Original Intended Dosage | Adjusted Dose | ||||
Original Intended Dosage | Adjusted Dose | Original Intended Dosage | Adjusted Dose | ||||
Cyclosporine Ranolazine | Significant increase in colchicine plasma levels *; fatal colchicine toxicity has been reported with cyclosporine, a P-gp inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other P-gp inhibitors. | 0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | 1.2 mg(2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | 0.6 mg(1 tablet) × 1 dose. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 1.2 – 2.4 mg | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
Protease Inhibitor | Clinical Comment | w/Colchicine – Prophylaxis of Gout Flares | w/Colchicine – Treatment of Gout Flares | w/Colchicine – Treatment of FMF | |
Atazanavir sulfate(Reyataz) | Patients with renal or hepatic impairment should not be given colchicine with Reyataz. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Darunavir (Prezista) | Patients with renal or hepatic impairment should not be given colchicine with Prezista/ritonavir. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Fosamprenavir (Lexiva) with Ritonavir | Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Fosamprenavir (Lexiva) | Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. | Original dose | Adjusted dose | 1.2 mg (2 tablets) × 1 dose. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg twice a day or 0.6 mg once a day0.3 mg once a day | ||||
Indinavir (Crixivan) | Patients with renal or hepatic impairment should not be given colchicine with Crixivan. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Lopinavir/Ritonavir (Kaletra) | Patients with renal or hepatic impairment should not be given colchicine with Kaletra. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Nelfinavir mesylate (Viracept) | Patients with renal or hepatic impairment should not be given colchicine with Viracept. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Ritonavir (Norvir) | Patients with renal or hepatic impairment should not be given colchicine with Norvir. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Saquinavir mesylate (Invirase) | Patients with renal or hepatic impairment should not be given colchicine with Invirase/ritonavir. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day | ||||
Tipranavir (Aptivus) | Patients with renal or hepatic impairment should not be given colchicine with Aptivus/ritonavir. | Original dose | Adjusted dose | 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. | Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) |
0.6 mg twice a day0.6 mg once a day | 0.3 mg once a day0.3 mg once every other day |
Treatment of gout flares with COLCRYS is not recommended in patients receiving prophylactic dose of COLCRYS and CYP3A4 inhibitors.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.