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Benzicap 500 Tablets

Generic Name– Capecitabine
Drug Class– Antineoplastic agent
Capecitabine is a nucleoside metabolic inhibitor used to treat metastatic and advanced forms of breast and colon cancer, often in combination with other agents. It is selectively activated by tumor cells to its cytotoxic moiety, 5-fluorouracil (5-FU). 5-FU acts by inhibiting nucleic acid synthesis, resulting in disruption of RNA, DNA and protein synthesis.

Category

Product Description

Benzicap 500 (Capecitabine) is an oral anticancer drug, available in tablet form.

Indications and Usage

Capecitabine is indicated for:
• Adjuvant colon cancer
• Metastatic colorectal cancer as first line monotherapy, when treatment with fluoropyrimidine therapy alone is preferred
• Metastatic breast cancer, in combination with docetaxel after failure of prior anthracycline containing therapy and as monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen

Dosage and Administration

• Dosage Regimens for Colorectal Cancer
Capecitabine Monotherapy1
Capecitabine 1250 mg/m2 twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles
Capecitabine plus Irinotecan (XELIRI) Regimen4
Irinotecan 250 mg/m2 IV on day 1
Capecitabine 1000 mg/m2 orally twice daily on days 1 to 14, every 3 weeks
Capecitabine plus Irinotecan (CAPIRI) Regimen5
Capecitabine 1000 mg/m2 orally twice daily on day 1-14
Irinotecan 100 mg/m2 IV on day 1 and 8 every 3 weeks
Capecitabine plus Oxaliplatin (CAPOX) Regimen6
Oxaliplatin 130 mg/m2 IVon the first day
Capecitabine 1000 mg/m2 every 12 hours on days 1 and 14
Repeat every 21 days for six to eight cycles
Capecitabine, Oxaliplatin and Irinotecan (COI) Regimen7

Irinotecan 180 mg/m2 IV infused over 90 min on day 1
Oxaliplatin 85 mg/m2 IV in a 3-hr infusion on day 2
Capecitabine 1000 mg/m2/day orally twice daily from days 2 to 6 of a biweekly schedule

• Dosage Regimen for Breast Cancer
Capecitabine plus Docataxel Regimen1
Capecitabine 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period
Docataxel 75 mg/m2 as a 1-hour IV infusion every 3 weeks

• Adjuvant treatment is recommended for a total of 6 months (8cycles)
• Take capecitabine with water within 30 min after a meal1

Dosage Form and Strength
• Supplied as tablets for oral use
• Available in 500mg strength

Clinical Efficacy

• Shows improved tolerability and comparable efficacy in treatment of various metastatic cancers such as colorectal and breast cancer
• Produces overall response rates of 26% in patients with metastatic colorectal cancer
• Reduces the risk of disease progression and death by 35% and 23% respectively, and significantly increases median survival and objective response rates in combination with docetaxel in patients with metastatic breast cancer

Adverse Reactions
• The most common adverse events that may occur after administration of capecitabine are diarrhea, nausea, vomiting, abdominal pain, fatigue/weakness, hand-and-foot syndrome and hyperbilirubinemia

Contraindications
• It is contraindicated in patients with a known hypersensitivity to capecitabine and severe renal impairment

Special Precautions

• Patients with hepatic and renal impairment should be monitored and dose should be reduced by 25% in patients with moderate renal impairment
• Monitor anticoagulant response and adjust anticoagulant dose accordingly in patients with a risk of coagulopathy
• Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated
• Discontinue capecitabine in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity
• Monitor and correct dehydration in patients with potential risk of acute renal failure secondary to dehydration and discontinue capecitabine until dehydration is corrected
• Treatment with capecitabine should be permanently discontinued in patients who experience a severe mucocutaneous reaction and hand-and-foot syndrome possibly attributable to capecitabine treatment.
• Administration of capecitabine should be interrupted immediately until the hyperbilirubinemia resolves or decreases in intensity
• Patients with neutrophil counts <1.5 x 109 /L or thrombocyte counts <100 x 109 /L, should not be treated with capecitabine. Discontinue therapy, if grade 3-4 neutropenia or thrombocytopenia occurs • Care should be exercised while using capecitabine in combination with phenytoin, leucovorin and CYP2C9 substrates, as it can result in potential drug interactions • Women of child bearing potential should be advised to use effective contraception to avoid pregnancy • It is not recommended in pregnant women and nursing mothers1

Benzicap 500 Tablets - ADMAC Life Science