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Xeloda is a brand name for Capecitabine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xeloda is indicated for the treatment of: - for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). - metastatic colorectal cancer (see section 5.1). - first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see…
Verbatim from this product's EMA label. Tap a section to expand.
Xeloda should only be prescribed by a qualified physician experienced in the utilisation of anti- neoplastic medicinal products. Careful monitoring during the first cycle of treatment is recommended for all patients. Treatment should be discontinued if progressive disease or intolerable toxicity is observed.
Standard and reduced dose calculations according to body surface area for starting doses of Xeloda of 1250 mg/m2 and 1000 mg/m2 are provided in tables 1 and 2, respectively. 1): Monotherapy Colon, colorectal and breast cancer Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months. 1). For combination with irinotecan, the recommended starting dose is 800 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period combined with irinotecan 200 mg/m2 on day 1.
The inclusion of bevacizumab in a combination regimen has no effect on the starting dose of capecitabine. Premedication to maintain adequate hydration and anti-emesis according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the capecitabine plus cisplatin combination.
Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination. Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
Breast cancer In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7- day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Premedication with an oral corticosteroid such as dexamethasone according to the docetaxel summary of product characteristics should be started prior to docetaxel administration for patients receiving the capecitabine plus docetaxel combination.
Summary of the safety profile The overall safety profile of capecitabine is based on data from over 3000 patients treated with capecitabine as monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications.
The safety profiles of capecitabine monotherapy for the metastatic breast cancer, metastatic colorectal cancer and adjuvant colon cancer populations are comparable. 1 for details of major studies, including study designs and major efficacy results.
The most commonly reported and/or clinically relevant treatment-related adverse drug reactions (ADRs) were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function, and thrombosis/embolism.
Tabulated list of adverse reactions ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of capecitabine are listed in table 4 for capecitabine given as monotherapy and in table 5 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Capecitabine Monotherapy:
Table 4 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796). ADRs are added to the appropriate frequency grouping according to the overall incidence from the pooled analysis.
4. 5 x 109/L and/or thrombocyte counts of <100 x 109/L should not be treated with capecitabine. 0 x 109/L or that the platelet count drops below 75 x 109/L, treatment with capecitabine should be interrupted. Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine or the other medicinal product(s), then administration of all therapy should be delayed until the requirements for restarting all medicinal products are met.
6 During a treatment cycle for those toxicities considered by the treating physician not to be related to capecitabine, capecitabine should be continued and the dose of the other medicinal product should be adjusted according to the appropriate Prescribing Information.
If the other medicinal product(s) have to be discontinued permanently, capecitabine treatment can be resumed when the requirements for restarting capecitabine are met. This advice is applicable to all indications and to all special populations.
Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Posology adjustments for special populations:
Hepatic impairment Insufficient safety and efficacy data are available in patients with hepatic impairment to provide a dose adjustment recommendation. No information is available on hepatic impairment due to cirrhosis or hepatitis.
5 for drug-drug interaction), • If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Capecitabine in European Union.
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19 2300 2 4 1750 1100 5 Posology adjustments during treatment General Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction). Once the dose has been reduced, it should not be increased at a later time.
g. alopecia, altered taste, nail changes, treatment can be continued at the same dose without reduction or interruption. Patients taking capecitabine should be informed of the need to interrupt treatment immediately if moderate or severe toxicity occurs.
Doses of capecitabine omitted for toxicity are not replaced.
The following are the recommended dose modifications for toxicity:
Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment) Toxicity grades* Dose changes within a treatment cycle Dose adjustment for next cycle/dose (% of starting dose) • Grade 1 Maintain dose level Maintain dose level • Grade 2 -1st appearance Interrupt until resolved to grade 0-1 100% -2nd appearance 75% -3rd appearance 50% -4th appearance Discontinue treatment permanently Not applicable • Grade 3 -1st appearance Interrupt until resolved to grade 0-1 75% -2nd appearance 50% -3rd appearance Discontinue treatment permanently Not applicable • Grade 4 -1st appearance Discontinue permanently or If physician deems it to be in the patient’s best interest to continue, interrupt until resolved to grade 0-1 50% -2nd appearance Discontinue permanently Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse […]
) 15 Body System Very Common All grades Common All grades Uncommon Severe and/or Life- threatening (grade 3-4) or considered medically relevant Rare/Very Rare (Post-Marketing Experience) Muskuloskelet al and connective tissue disorders - Pain in extremity, Back pain, Arthralgia Joint swelling, Bone pain, Facial pain, Musculoskeletal stiffness, Muscular weakness Renal and urinary disorders - - Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased Reproductive system and breast disorders - - Vaginal haemorrhage General disorders and administration site conditions Fatigue, Asthenia Pyrexia, Oedema peripheral, Malaise, Chest pain Oedema, […]
Renal impairment Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockcroft and Gault] at baseline). The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 mL/min at baseline) is increased compared to the overall population.
In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m2 is recommended. In patients with moderate renal impairment at baseline, no dose reduction is required for a starting dose of 1000 mg/m2.
In patients with mild renal impairment (creatinine clearance 51-80 mL/min at baseline) no adjustment of the starting dose is recommended. Careful monitoring and prompt treatment interruption is recommended if the patient develops a grade 2, 3 or 4 adverse event during treatment and subsequent dose adjustment as outlined in table 3 above.
If the calculated creatinine clearance decreases during treatment to a value below 30 mL/min, Xeloda should be discontinued. These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section “Elderly” below).
Elderly During capecitabine monotherapy, no adjustment of the starting dose is needed. However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients. When capecitabine was used in combination with other medicinal products, elderly patients (≥65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation, compared to younger patients.
Careful monitoring of patients ≥60 years of age is advisable. 1). For patients 60 years of age or more, a starting dose reduction of capecitabine to 75% (950 mg/m2 twice daily) is recommended. If no toxicity is observed in patients ≥60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1250 mg/m2 twice daily.
Paediatric population There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer. 7 Method of administration Xeloda tablets should be swallowed whole with water within 30 minutes after a meal.
Xeloda tablets should not be crushed or cut. 5 for drug-drug interaction), • If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used. 4 Special warnings and precautions for use Dose limiting toxicities Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be withheld or reduced. Diarrhoea. Patients […]