Loading…
ACH-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: ACH-CAPECITABINE (capecitabine) is a potent drug and should be prescribed only by physicians experienced with cancer chemotherapeutic drugs. ACH-CAPECITABINE (capecitabine) is indicated for: Colorectal Cancer Monotherapy • ACH-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 ACH-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 ACH-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, ACH-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 ACH-CAPECITABINE is 1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
The first dose of ACH-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 ACH-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 ACH-CAPECITABINE plus docetaxel combination. Dose calculation ACH-CAPECITABINE dose is calculated according to body surface area.
Tables 1 and 2 show examples of the standard and reduced dose calculations for a ACH-CAPECITABINE starting dose of either 1250 mg/m2 or 1000 mg/m2. 19 2300 2 4 1750 1100 Product Monograph ACH-CAPECITABINE Page 9 of 65 Dose Modification Guidelines Patients should be carefully monitored for toxicity.
, Endocrine and Metabolism, Dihydropyrimidine dehydrogenase (DPD) deficiency 04/2026 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 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......................................................................................
04/2026 3 SERIOUS WARNING AND PRECAUTIONS BOX 04/2026 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Dihydropyrimidine dehydrogenase (DPD) deficiency 04/2026 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 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
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 ACH-CAPECITABINE administration may be managed by symptomatic treatment, dose interruptions and adjustment of ACH-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 ACH-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 ACH- 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 ACH- CAPECITABINE therapy may be restarted at full dose or as adjusted according to Table 3 for ACH-CAPECITABINE monotherapy. If a grade 4 event occurs, therapy should be discontinued or interrupted until resolved or decreased to grade […]
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 ..................................................................... 5 Post-Market Adverse Reactions ............................................................................................
31 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 MONOGRAPHS ..................................................................... 58 PATIENT MEDICATION INFORMATION ................................................................................... 59 Product Monograph ACH-CAPECITABINE Page 4 of 65 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Caution: ACH-CAPECITABINE (capecitabine) is a potent drug and should […]