Capecitabine Teva

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Capecitabine Teva should only be prescribed by a qualified physician experienced in the utilisation of antineoplastic 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 Capecitabine Teva of 1250 mg/m² and 1000 mg/m² are provided in tables 1 and 2 at the attached doctor’s leaflet, respectively.
Recommended posology:
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.
Combination therapy: Colon, colorectal and gastric cancer: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 -1000 mg/m² when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m² twice daily when administered continuously.
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.
See prescribing information for full details.
Haematology: Patients with baseline neutrophil counts of <1.5 x 10^9/L and/or thrombocyte counts of <100 x 10^9/L should not be treated with capecitabine. If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 10^9 /L or that the platelet count drops below 75 x 10^9 /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.
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 at the attached doctor’s leaflet for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
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.
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 at the attached doctor’s leaflet. If the calculated creatinine clearance decreases during treatment to a value below
30 ml/min, Capecitabine Teva 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.
– In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more. 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.
Method of administration: Capecitabine Teva tablets should be swallowed whole with water within 30 minutes after a meal.
Capecitabine Teva tablets should not be crushed or cut.

Adjuvant Colon Cancer: Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.
Colorectal Cancer: Capecitabine Teva is indicated for the treatment of patients with advanced or metastatic colorectal cancer.
Advanced gastric cancer: Capecitabine Teva is indicated for first line treatment of advanced gastric cancer in combination with chemotherapy.
Breast Cancer Combination Therapy: Capecitabine Teva in combination with docetaxel  is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Breast Cancer Monotherapy: Capecitabine Teva is also indicated for the treatment of advanced or metastatic breast cancer after failure: of standard therapy including a taxane, unless therapy with a taxane is clinically contraindicated.

Hypersensitivity to the active substance or to any of the excipients or fluorouracil.
History of severe and unexpected reactions to fluoropyrimidine therapy.
In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
During pregnancy and lactation.
In patients with severe leukopenia, neutropenia, or thrombocytopenia.
In patients with severe hepatic impairment.
In patients with severe renal impairment (creatinine clearance below 30 ml/min).
Recent or concomitant treatment with brivudine.
If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.

Pregnancy: There are no studies in pregnant women using capecitabine; however, it should be assumed that capecitabine may cause foetal harm if administered to pregnant women. In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity. These findings are expected effects of fluoropyrimidine derivatives. Capecitabine Teva is contraindicated during pregnancy.
Lactation: It is not known whether capecitabine is excreted in human breast milk. No studies have been conducted to assess the impact of capecitabine on milk production or its presence in human breast milk. In lactating mice, considerable amounts of capecitabine and its metabolites were found in milk. As the potential for harm to the nursing infant is unknown, breast-feeding should be discontinued while receiving treatment with capecitabine teva and for 2 weeks after the final dose.

The manifestations of acute overdose include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.