Capixet Tablet

Capixet Tablet is used for: Colorectal Cancer, Breast cancer, Gastric, Esophageal, or Gastroesophageal Junction Cancer, Pancreatic Cancer

Oral Colon Cancer - adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. - perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. - treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. Single agent: 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle for a maximum of 8 cycles. In combination with Oxaliplatin-Containing Regimens: 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2 administered intravenously on day 1 of each cycle. Perioperative Treatment of Rectal Cancer: • With Concomitant Radiation Therapy: 825 mg/m2 orally twice daily • Without Radiation Therapy: 1,250 mg/m2 orally twice daily Unresectable or Metastatic Colorectal Cancer: • Single agent: 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. In Combination with Oxaliplatin: 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2 administered intravenously on day 1 of each cycle. Breast Cancer - treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. - treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. Single agent: 1,000 mg/m2 or 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. (2.2) In combination with docetaxel: 1,000 mg/m2 or 1,250 mg/m2 orally twice daily for the first 14 days of a 21-day cycle, until disease progression or unacceptable toxicity in combination with docetaxel at 75 mg/m2 administered intravenously on day 1 of each cycle Gastric, Esophageal, or Gastroesophageal Junction Cancer - treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. - treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. Unresectable or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Cancer • 625 mg/m2 orally twice daily on days 1 to 21 of each 21-day cycle for a maximum of 8 cycles in combination with platinum-containing chemotherapy. OR • 850 mg/m2 or 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2 administered intravenously on day 1 of each cycle. HER2-overexpressing metastatic adenocarcinoma of the gastroesophageal junction or stomach • 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with cisplatin and trastuzumab. Pancreatic Cancer - adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. 830 mg/m2 orally twice daily for the first 21 days of each 28-day cycle for maximum of 6 cycles in combination with gemcitabine 1,000 mg/m2 administered intravenously on days 1, 8, and 15 of each cycle.

Renal impairment Mild (CrCl 51-80 mL/min): No dose reduction necessary Moderate (CrCl 30-50 mL/min): Reduce dose to 75% of starting dose (ie, from 1250 mg/m2 to 950 mg/m2 BID) Severe (CrCl <30 mL/min): Contraindicated

Swallow with water within 30 min after a meal

History of severe and unexpected reactions to fluoropyrimidine therapy; severe renal impairment; pregnancy, lactation. Hypersensitivity.

• Serious Adverse Reactions from Dihydropyrimidine Dehydrogenase (DPD) Deficiency: Patients with certain homozygous or compound heterozygous variants in the DPYD gene are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions due to Capecitabine (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity). Capecitabine is not recommended for use in patients known to have certain homozygous or compound heterozygous DPYD variants that result in complete absence of DPD activity. Withhold or permanently discontinue based on clinical assessment. No Capecitabine dose has been proven safe in patients with complete absence of DPD activity. • Cardiotoxicity: May be more common in patients with a prior history of coronary artery disease. Withhold Capecitabine for cardiotoxicity as appropriate. The safety of resumption of Capecitabine in patients with cardiotoxicity that has resolved has not been established. • Diarrhea: Withhold Capecitabine and then resume at same or reduced dose, or permanently discontinue, based on severity and occurrence. • Dehydration: Optimize hydration before starting Capecitabine. Monitor hydration status and kidney function at baseline and as clinically indicated. Withhold Capecitabine and then resume at same or reduced dose, or permanently discontinue, based on severity and occurrence. • Renal Toxicity: Monitor renal function at baseline and as clinically indicated. Optimize hydration before starting Capecitabine. Withhold Capecitabine and then resume at same or reduced dose, or permanently discontinue, based on severity and occurrence. • Serious Skin Toxicities: Monitor for new or worsening serious skin reactions. Permanently discontinue Capecitabine in patients who experience a severe cutaneous adverse reaction. • Palmar-Plantar Erythrodysesthesia Syndrome: Withhold Capecitabine then resume at same or reduced dose, or permanently discontinue, based on severity and occurrence. • Myelosuppression: Monitor complete blood count at baseline and before each cycle. Capecitabine is not recommended in patients with baseline neutrophil counts <1.5 x 109/L or platelet counts <100 x 109/L. For grade 3 or 4 myelosuppression, withhold Capecitabine and then resume at same or reduced dose, or permanently discontinue, based on occurrence. • Hyperbilirubinemia: Patients with Grade 3-4 hyperbilirubinemia may resume treatment once the event is Grade 2 or less (<3 x ULN), using the percent of current dose as shown in column 3 of Table 1 • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. MONITORING PARAMETERS ▶ Monitor plasma-calcium concentration. ▶ Monitor for eye disorders (including keratitis and corneal disorders). ▶ Severe skin reactions Monitor for symptoms of severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis)—permanently discontinue treatment immediately if symptoms occur. ▶ Hand-foot syndrome Monitor for symptoms of hand-foot syndrome—interrupt treatment if significant syndrome occurs.

Pregnancy Based on findings in animal reproduction studies and its mechanism of action, fetal harm may occur when administered to pregnant females; limited available human data are not sufficient to inform drug-associated risk during pregnancy Pregnancy testing recommended for females of reproductive potential before initiating therapy Animal studies Therapy in pregnant animals during organogenesis caused embryo lethality and teratogenicity in mice and embryo lethality in monkeys at 0.2 and 0.6 times, respectively, the exposure (AUC) in patients Contraception Females of reproductive potential: Use effective contraception during treatment and for 6 months after last dose Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after last dose Infertility Based on animal studies, may impair fertility in females and males Lactation Data are unavailable regarding presence in human milk, effects on milk production, or effects on breastfed infants; drug metabolites were present in milk of lactating mice Owing to potential for serious adverse reactions from exposure in breastfed infants, advise females not to breastfeed during therapy and for 2 weeks after final dose

Allopurinol: Avoid concomitant use of allopurinol with Capecitabine. • Leucovorin: Closely monitor for toxicities when Capecitabine is coadministered with leucovorin. • CYP2C9 substrates: Closely monitor for adverse reactions when CYP2C9 substrates are coadministered with Capecitabine. • Vitamin K antagonists: Monitor INR more frequently and dose adjust oral vitamin K antagonist as appropriate • Phenytoin: Closely monitor phenytoin levels in patients taking Capecitabine concomitantly with phenytoin and adjust the phenytoin dose as appropriate. • Nephrotoxic drugs: Closely monitor for signs of renal toxicity when Capecitabine is used concomitantly with nephrotoxic drugs. Contraindicated (0) Serious (21) adenovirus types 4 and 7 live, oral axicabtagene ciloleucel brexucabtagene autoleucel cedazuridine ciltacabtagene autoleucel deferiprone enoxaparin erdafitinib etrasimod fexinidazole givinostat idecabtagene vicleucel influenza virus vaccine quadrivalent, adjuvanted influenza virus vaccine trivalent, adjuvanted lefamulin lisocabtagene maraleucel palifermin ropeginterferon alfa 2b siponimod tisagenlecleucel tofacitinib

Side effects of Capecitabine : 10% Diarrhea,Nausea,Anemia,Lymphopenia,Hand and foot syndrome,Edema,Fatigue,Fever,Headache,Pain,Paresthesia,Alopecia,Dermatitis,Abdominal pain,Anorexia,Appetite decreased,Constipation,Dyspepsia,Stomatitis,Vomiting,Neutropenia,Thrombocytopenia,Dyspnea,Bilirubin increased,Eye irritation 1-10% Chest pain,Dermatitis,Pruritus,Rash,Dizziness,Headache,Weakness,Dehydration,Dry mouth,Dyspepsia,Taste disturbance,Back pain Potentially Fatal: Cardiotoxicity, bone-marrow depression and hyperbilirubinaemia.

Capecitabine is a prodrug that is converted to fluorouracil following oral administration, which in turn inhibits thymidylate synthetase, blocking the methylation of deoxyuridylic acid to thymidylic acid, interfering with DNA, and to a lesser degree, RNA synthesis.

Capixet 500 mg Tablet manufactured by Everest Pharmaceuticals Ltd.. Its generic name is Capecitabine. Capixet is availble in Bangladesh. Farmaco BD drug index information on Capixet Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.