COLCRYS- colchicine tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Colchicine (UNII: SML2Y3J35T) (Colchicine - UNII:SML2Y3J35T)

זמין מ:

Takeda Pharmaceuticals America, Inc.

INN (שם בינלאומי):

Colchicine

הרכב:

Colchicine 0.6 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. COLCRYS (colchicine, USP) tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF). Patients with renal or hepatic impairment should not be given COLCRYS in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Risk Summary Available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Colchicine crosses the human placenta. Although animal reproductive and developmental studies were not conducted with COLCRYS (colchicine), published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, Behcet's disease, or familial Mediterranean fever (FMF) treated with colchicine at therapeutic doses during pregnancy. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. Risk Summary Colchicine is present in human milk (see Data) . Adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. There are no data on the effects of colchicine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COLCRYS and any potential adverse effects on the breastfed child from COLCRYS or from the underlying maternal condition. Data Limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. A systematic review of literature reported no adverse effects in 149 breastfed children. In a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants. Infertility Case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. A case report indicated that azoospermia was reversed when therapy was stopped. Case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility. However, since the progression of FMF without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see Nonclinical Toxicology (13.1)] . The safety and efficacy of colchicine in children of all ages with FMF has been evaluated in uncontrolled studies. There does not appear to be an adverse effect on growth in children with FMF treated long-term with colchicine. Safety and effectiveness of colchicine in pediatric patients with gout has not been established. Clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of FMF did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)] . Colchicine is significantly excreted in urine in healthy subjects. Clearance of colchicine is decreased in patients with impaired renal function. Total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis. Prophylaxis of Gout Flares For prophylaxis of gout flares in patients with mild (estimated creatinine clearance Clcr 50 to 80 mL/min) to moderate (Clcr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see Dosage and Administration (2.5)] . Treatment of Gout Flares For treatment of gout flares in patients with mild (Clcr 50 to 80 mL/min) to moderate (Clcr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of COLCRYS. However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. For patients with gout flares requiring repeated courses, consideration should be given to alternate therapy. For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet). For these patients, the treatment course should not be repeated more than once every two weeks [see Dosage and Administration (2.5)] . FMF Although pharmacokinetics of colchicine in patients with mild (Clcr 50 to 80 mL/min) and moderate (Clcr 30 to 50 mL/min) renal impairment is not known, these patients should be monitored closely for adverse effects of colchicine. Dose reduction may be necessary. In patients with severe renal failure (Clcr less than 30 mL/min) and end-stage renal disease requiring dialysis, COLCRYS may be started at the dose of 0.3 mg/day. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of COLCRYS [see Clinical Pharmacology (12.3), Dosage and Administration (2.5)] . The clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment compared to healthy subjects [see Clinical Pharmacology (12.3)] . Prophylaxis of Gout Flares For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. Dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see Dosage and Administration (2.6)] . Treatment of Gout Flares For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended COLCRYS dose is not required, but patients should be monitored closely for adverse effects of COLCRYS. However, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, the treatment course should be repeated no more than once every two weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Dosage and Administration (2.6)] . FMF In patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see Clinical Pharmacology (12.3), Dosage and Administration (2.6)] . Tolerance, abuse or dependence with colchicine has not been reported.

leaflet_short:

COLCRYS (colchicine, USP) tablets 0.6 mg are purple, film-coated, capsule-shaped tablets debossed with "AR 374" on one side and scored on the other side. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

מצב אישור:

New Drug Application

עלון מידע

Takeda Pharmaceuticals America, Inc.
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration
COL243 R4
Revised: May 2020
MEDICATION GUIDE
COLCRYS (KOL-kris)
(colchicine)
tablets, for oral use
Read the Medication Guide that comes with COLCRYS before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
healthcare provider about your medical condition or treatment. You and
your healthcare provider should
talk about COLCRYS when you start taking it and at regular checkups.
What is the most important information that I should know about
COLCRYS?
COLCRYS can cause serious side effects or death if levels of COLCRYS
are too high in your body.
•
Taking certain medicines with COLCRYS can cause your level of COLCRYS
to be too high,
especially if you have kidney or liver problems.
•
Tell your healthcare provider about all your medical conditions,
including if you have kidney or
liver problems. Your dose of COLCRYS may need to be changed.
•
Tell your healthcare provider about all the medicines you take,
including prescription and
nonprescription medicines, vitamins and herbal supplements.
•
Even medicines that you take for a short period of time, such as
antibiotics, can interact with
COLCRYS and cause serious side effects or death.
•
Talk to your healthcare provider or pharmacist before taking any new
medicine.
•
Especially tell your healthcare provider if you take:
•
atazanavir sulfate (Reyataz)
•
cyclosporine (Neoral, Gengraf,
Sandimmune)
•
fosamprenavir (Lexiva) with ritonavir
•
indinavir (Crixivan)
•
ketoconazole (Nizoral)
•
nefazodone (Serzone)
•
ritonavir (Norvir)
•
telithromycin (Ketek)
•
clarithromycin (Biaxin)
•
darunavir (Prezista)
•
fosamprenavir (Lexiva)
•
itraconazole (Sporanox)
•
lopinavir/ritonavir (Kaletra)
•
nelfinavir mesylate (Viracept)
•
saquinavir mesylate (Invirase)
•
tipranavir (Aptivus)
Ask your healthcare provider or pharmacist i

מאפייני מוצר

COLCRYS- COLCHICINE TABLET, FILM COATED
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLCHICINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COLCRYS.
COLCRYS (COLCHICINE, USP) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1961
INDICATIONS AND USAGE
COLCRYS (colchicine, USP) is an alkaloid indicated for:
Prophylaxis and treatment of gout flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or
older (1.2).
DOSAGE AND ADMINISTRATION
GOUT FLARES:
FMF: Adults and children older than 12 years 1.2 – 2.4 mg; children
6 to 12 years 0.9 – 1.8 mg; children
4 to 6 years 0.3 – 1.8 mg (2.2, 2.3).
Give total daily dose in one or two divided doses (2.2).
Increase or decrease the dose as indicated and as tolerated in
increments of 0.3 mg/day, not to
exceed the maximum recommended daily dose (2.2).
Colchicine tablets are administered orally without regard to meals.
See full prescribing information (FPI) for dose adjustment regarding
patients with impaired renal
function (2.5), impaired hepatic function (2.6), the patient's age
(2.3, 8.5) or use of coadministered
drugs (2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 0.6 mg colchicine (3)
CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given COLCRYS
in conjunction with P-gp or strong
CYP3A4 inhibitors (5.3). In these patients, life-threatening and fatal
colchicine toxicity has been reported
with colchicine taken in therapeutic doses (7).
WARNINGS AND PRECAUTIONS
_Fatal overdoses_ have been reported with colchicine in adults and
children. Keep COLCRYS out of the
reach of children (5.1, 10).
_Blood dyscrasias:_ myelosuppression, leukopenia, granulocytopenia,
thrombocytopenia and aplastic
anemia have been reported (5.2).
Monitor for toxicity and if present consider temporary interruption or
discontinuation of colchicine (5.2,
5.3, 5.4, 6, 10).
_Drug interaction P-gp and/or CYP3A4 inhibitors:_ Coadminist