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MINT-CAPECITABINE is a brand name for Capecitabine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Caution: MINT-CAPECITABINE (capecitabine) is a potent drug and should be prescribed only by physicians experienced with cancer chemotherapeutic drugs. MINT-CAPECITABINE (capecitabine) is indicated for: Colorectal Cancer Monotherapy • MINT-CAPECITABINE (capecitabine) is indicated for the adjuvant treatment of patients…
Verbatim from this product's HC label. Tap a section to expand.
). 2 CONTRAINDICATIONS Capecitabine is contraindicated in patients who are hypersensitive to this drug, or 5-fluorouracil or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
5 Post-Market Adverse Reactions). • If patients cannot swallow MINT-CAPECITABINE tablets whole and tablets must be crushed or cut, this should be done by a professional trained in the safe handling of cytotoxic drugs (see 12 SPECIAL HANDLING INSTRUCTIONS).
2 Recommended Dose and Dosage Adjustment • Monotherapy: The recommended dose of MINT-CAPECITABINE (capecitabine) is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a seven day rest period.
For adjuvant treatment of stage III colon cancer, MINT-CAPECITABINE is intended to be given for a total of 8 cycles (or 24 weeks). • Colorectal Cancer, Combination Therapy with Oxaliplatin: In combination with oxaliplatin, the recommended dose of MINT-CAPECITABINE is 1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
The first dose of MINT-CAPECITABINE is given on the evening of day 1 and the last dose is given on the morning of day 15. Given as a 3-weekly schedule, oxaliplatin is administered as a 130 mg/m2 intravenous infusion over 2 hours. Premedication to maintain adequate anti-emesis according to the oxaliplatin Product Monograph should be started prior to oxaliplatin administration for patients receiving the MINT-CAPECITABINE plus oxaliplatin combination.
2 Study Results, Breast Carcinoma). Premedication according to the docetaxel labelling, should be started prior to docetaxel administration for patients receiving the MINT-CAPECITABINE plus docetaxel combination. Dose calculation MINT-CAPECITABINE dose is calculated according to body surface area.
Tables 1 and 2 show examples of the standard and reduced dose calculations for a MINT-CAPECITABINE starting dose of either 1250 mg/m2 or 1000 mg/m2. 19 2300 2 4 1750 1100 Unclassified / Non classifié Dose Modification Guidelines Patients should be carefully monitored for toxicity.
, Endocrine and Metabolism, Dihydropyrimidine dehydrogenase (DPD) deficiency 05/2026 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 05/2026 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ...............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ................................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics .................................................................................................................
5 2 CONTRAINDICATIONS .................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 6 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 5 Missed Dose ..........................................................................................................
11 5 OVERDOSAGE............................................................................................................. 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 11 7 WARNINGS AND PRECAUTIONS .................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Toxicity due to MINT-CAPECITABINE administration may be managed by symptomatic treatment, dose interruptions and adjustment of MINT-CAPECITABINE dose. Once the dose has been reduced, it should not be increased at a later time. For those toxicities considered by the treating physician to be unlikely to become serious or life- threatening, treatment can be continued at the same dose without reduction or interruption.
Dose modifications for the use of MINT-CAPECITABINE are shown in Table 3. 0. For Hand-and-Foot Syndrome and hyperbilirubinemia (see 7 WARNINGS AND PRECAUTIONS). Dosage modifications are not recommended for grade 1 events. Therapy with MINT- CAPECITABINE should be interrupted upon the occurrence of a grade 2 or 3 adverse experience.
Once the adverse event has resolved or decreased in intensity to grade 1, then MINT-CAPECITABINE therapy may be restarted at full dose or as adjusted according to Table 3 for MINT-CAPECITABINE monotherapy. If a grade 4 event occurs, therapy should be […]
1 Special Populations................................................................................................ 1 Pregnant Women ............................................................................................ 2 Breast-feeding .................................................................................................
3 Pediatrics ......................................................................................................... 4 Geriatrics .........................................................................................................
18 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ...................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions ............................................................................ 32 9 DRUG INTERACTIONS ................................................................................................. 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions.......................................................................................... 34 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .......................................................................................
3 Pharmacokinetics ............................................................................................ 35 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 37 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
37 PART II: SCIENTIFIC INFORMATION ........................................................................................ 39 13 PHARMACEUTICAL INFORMATION .............................................................................
39 14 CLINICAL TRIALS ......................................................................................................... 1 Trial Design and Study Demographics ............................................................. 2 Study Results ...................................................................................................
3 Comparative Bioavailability Studies................................................................. 47 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 49 17 SUPPORTING PRODUCT MONOGRAPH .......................................................................
58 PATIENT MEDICATION INFORMATION ................................................................................... 59 Product Monograph MINT-CAPECITABINE Page 4 of 66 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Caution: MINT-CAPECITABINE (capecitabine) is a potent drug and should be prescribed only by physicians experienced with cancer chemotherapeutic drugs.
MINT-CAPECITABINE (capecitabine) is indicated for:
Colorectal Cancer Monotherapy • MINT-CAPECITABINE (capecitabine) is indicated for the adjuvant treatment of patients with stage III (Dukes’ stage C) colon cancer. • […]