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TARO-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: Taro-Capecitabine (capecitabine) is a potent drug and should be prescribed only by physicians experienced with cancer chemotherapeutic drugs. Taro-Capecitabine is indicated for: Colorectal Cancer Monotherapy • Taro-Capecitabine is indicated for the adjuvant treatment of patients with stage III (Dukes’ stage…
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 Taro-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 Taro-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, Taro-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 Taro-Capecitabine is 1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
The first dose of Taro- 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 Taro-Capecitabine plus oxaliplatin combination Taro-Capecitabine (Capecitabine Tablets) Page 7 of 65 Unclassified / Non classifié • Locally advanced and/or Metastatic Breast Cancer, Combination Therapy with Docetaxel: In combination with docetaxel, the recommended starting dose of Taro- Capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period combined with docetaxel 75 mg/m2 administered as a 1-hour intravenous infusion every 3 weeks (see 10 CLINICAL PHARMACOLOGY, 14 CLINICAL TRIALS, Breast Carcinoma).
Premedication according to the docetaxel labelling, should be started prior to docetaxel administration for patients receiving the Taro-Capecitabine plus docetaxel combination. Dose calculation Taro-Capecitabine dose is calculated according to body surface area.
, Endocrine and Metabolism 05/2026 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 05/2026 7 WARNINGS AND PRECAUTIONS, Dihydropyrimidine dehydrogenase (DPD) deficiency 05/2026 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed.
RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS .....................................................................................................................
1 Pediatrics ....................................................................................................................... 2 Geriatrics .......................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................
5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations ...................................................................................................
2 Recommended Dose and Dosage Adjustment............................................................... 5 Missed Dose ................................................................................................................ 1 Special Populations......................................................................................................
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. 5 mL/s). • Complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
Testing for DPD deficiency should be performed prior to initiating Taro-Capecitabine unless immediate treatment is necessary, based on the local availability and current guidelines (see 7 WARNINGS and PRECAUTIONS,Dihydropyrimidine dehydrogenase (DPD) deficiency and Monitoring and Laboratory Tests).
Due to potentially fatal drug interaction, Taro-Capecitabine should not be administered concomitantly with sorivudine1 or its chemically related analogues, such as brivudine. If contraindications exist to any of the agents in a combination regimen, that agent should not be used.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Capecitabine in Canada.
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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.
Tables 1 and 2 show examples of the standard and reduced dose calculations for a Taro-Capecitabine starting dose of either 1250 mg/m2 or 1000 mg/m2. 19 1150 1300 1450 1600 1750 1800 2000 2150 2300 1 2 3 4 5 2 - 1 2 2 2 2 2 2 3 4 4 4 800 1000 1100 1200 1300 1400 1500 1600 1750 600 600 750 800 800 900 1000 1050 1100 Dose Modification Guidelines Patients should be carefully monitored for toxicity.
Toxicity due to Taro-Capecitabine administration may be managed by symptomatic treatment, dose interruptions and adjustment of Taro-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 Taro-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 Taro- 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 Taro-Capecitabine therapy may be restarted at full dose or as adjusted according to Table 3 for Taro-Capecitabine […]
1 Pregnant Women ................................................................................................................................... 2 Breast-feeding........................................................................................................................................
3 Pediatrics ............................................................................................................................................... 4 Geriatrics ................................................................................................................................................
1 Adverse Drug Reaction Overview ................................................................................ 2 Clinical Trial Adverse Drug Reactions ........................................................................... 3 Less Common Clinical Trial Adverse Drug Reactions ....................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ................................................................................................................................... 5 Post-Market Adverse Reactions...................................................................................
4 Drug-Drug Interactions ................................................................................................ 5 Drug-Food Interactions ................................................................................................
1 Mechanism of Action ................................................................................................. 3 Pharmacokinetics ......................................................................................................
1 Trial Design and Study Demographics ....................................................................... 2 Study Results .............................................................................................................
3 Comparative Bioavailability Studies........................................................................... 58 Taro-Capecitabine (Capecitabine Tablets) Page […]