Loading…
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: CAPECITABINE (capecitabine) is a potent drug and should be prescribed only by physicians experienced with cancer chemotherapeutic drugs. CAPECITABINE (capecitabine) is indicated for: Colorectal Cancer Monotherapy • CAPECITABINE (capecitabine) is indicated for the adjuvant treatment of patients with stage III…
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 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 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, 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 CAPECITABINE is 1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
The first dose of 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 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 CAPECITABINE plus docetaxel combination. Dose calculation CAPECITABINE dose is calculated according to body surface area.
Tables 1 and 2 show examples of the standard and reduced dose calculations for a CAPECITABINE starting dose of either 1250 mg/m2 or 1000 mg/m2. 19 2300 2 4 1750 1100 Product Monograph CAPECITABINE Page 9 of 65 Unclassified / Non classifié Dose Modification Guidelines Patients should be carefully monitored for toxicity.
04/2026 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 ................................................................................. 1 Special Populations................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Capecitabine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Toxicity due to CAPECITABINE administration may be managed by symptomatic treatment, dose interruptions and adjustment of 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 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 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 CAPECITABINE therapy may be restarted at full dose or as adjusted according to Table 3 for CAPECITABINE monotherapy. If a grade 4 event occurs, therapy should be discontinued or interrupted until resolved or decreased to grade 1, […]
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 Product Monograph CAPECITABINE Page 3 of 65 Unclassified / Non classifié 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 CAPECITABINE Page 4 of 65 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Caution: CAPECITABINE (capecitabine) is a potent drug and should be prescribed only by physicians experienced with cancer chemotherapeutic drugs.
CAPECITABINE (capecitabine) is indicated for:
Colorectal Cancer Monotherapy • CAPECITABINE (capecitabine) is indicated for the adjuvant treatment of patients with stage III (Dukes’ stage C) colon cancer. • CAPECITABINE is also indicated for the first-line treatment of patients with metastatic colorectal cancer.
Combination Therapy CAPECITABINE in combination with oxaliplatin is […]