Zalobin Tablets 500mg (Capecitabine)

Adult dose

This medicine should be swallowed whole with water within 30 minutes after a meal. Do not cut or crush this medicine. If the patient cannot swallow this medicine whole and the tablet must be cut or crushed, this should be done by a professional trained in the safe handling of cytotoxic drugs. ○ Colorectal cancer, breast cancer The recommended dosage of this medicine is 1,250mg/㎡ twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in 3-week cycles. When used in combination with docetaxel, the recommended dosage of this medicine is 1,250mg/m2 twice daily (approximately 12 hours apart) for 2 weeks, followed by a 1-week rest period, in 3-week cycles; docetaxel 75mg/m2 is administered intravenously over 1 hour every 3 weeks. When this medicine is used in combination with docetaxel, premedication should be given before docetaxel administration in accordance with the prescribing information for docetaxel. For metastatic colorectal cancer, when used in combination with oxaliplatin, the recommended dosage of this medicine is 1000mg/m2 twice daily for 2 weeks, followed by a 1-week rest period, in 3-week cycles. Bevacizumab does not affect the starting dose of this medicine. For adjuvant treatment after surgery for stage III (Dukes‘ C) colon cancer, administer as follows. When this medicine is administered as monotherapy, it is recommended to administer 1,250mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in 3-week cycles, for a total of 8 cycles (24 weeks). When this medicine is used in combination with oxaliplatin, it is recommended to administer this medicine at 1,000mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in 3-week cycles. Oxaliplatin is administered by intravenous infusion over 2 hours at 130mg/m2 on Day 1 of each cycle, before the first dose of this medicine, for a total of 8 cycles (24 weeks). When this medicine is used in combination with oxaliplatin, administration of an antiemetic and premedication before oxaliplatin is recommended in accordance with the prescribing information for oxaliplatin. ○ Gastric cancer 1) Unresectable advanced or metastatic gastric cancer The recommended dosage of this medicine is 1,250mg/㎡ twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in 3-week cycles. 2) First-line treatment of advanced gastric cancer in combination with a platinum-based regimen It is recommended to administer a starting dose of 1,000mg/m2 twice daily orally for 2 weeks, followed by a 1-week rest period, in 3-week cycles, or 625mg/m2 twice daily continuously for 3 weeks. When this medicine is used in combination with cisplatin, premedication should be given before cisplatin administration in accordance with the prescribing information for cisplatin. ① When used in combination with cisplatin, the recommended dosage of this medicine is 1,000mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in 3-week cycles; cisplatin 80mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks. ② When used in combination with cisplatin and epirubicin, the recommended dosage of this medicine is 625mg/m2 twice daily (morning and evening) continuously for 3 weeks in 3-week cycles; cisplatin 60mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks, and epirubicin 50mg/m2 is administered intravenously as a bolus every 3 weeks. ③ When used in combination with oxaliplatin and epirubicin, the recommended dosage of this medicine is 625mg/m2 twice daily (morning and evening) continuously for 3 weeks in 3-week cycles; oxaliplatin 130mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks, and epirubicin 50mg/m2 is administered intravenously as a bolus every 3 weeks. 3) When used in combination with oxaliplatin as adjuvant treatment after surgery for stage Ⅱ, Ⅲ gastric cancer, the recommended dosage of this medicine is 1000 mg/m2 orally twice daily for 2 weeks, followed by a 1-week rest period, in 3-week cycles. Oxaliplatin 130 mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks. ○ The following table shows the total dose per administration according to body surface area and the number of tablets to take at each administration. Dose calculation based on body surface area (1250mg/m2) 1250mg/m2 per dose (twice daily) 1250mg/m2 Number of tablets to take at each dose (morning, evening) (75% dose) 950mg/m2 (50% dose) 625mg/m2 Body surface area (m2) Dose per administration (mg) 150mg 500mg Dose per administration (mg) Dose per administration (mg) ≤1.26: 1500, 0, 3, 1150, 800 1.27～1.38: 1650, 1, 3, 1300, 800 1.39～1.52: 1800, 2, 3, 1450, 950 1.53～1.66: 2000, 0, 4, 1500, 1000 1.67～1.78: 2150, 1, 4, 1650, 1000 1.79～1.92: 2300, 2, 4, 1800, 1150 1.93～2.06: 2500, 0, 5, 1950, 1300 2.07～2.18: 2650, 1, 5, 2000, 1300 ≥2.19: 2800, 2, 5, 2150, 1450 Dose calculation based on body surface area (1000mg/m2) 1000mg/m2 per dose (twice daily) 1000mg/m2 Number of tablets to take at each dose (morning, evening) (75% dose) 750mg/m2 (50% dose) 500mg/m2 Body surface area (m2) Dose per administration (mg) 150mg 500mg Dose per administration (mg) Dose per administration (mg) ≤1.26: 1150, 1, 2, 800, 600 1.27～1.38: 1300, 2, 2, 1000, 600 1.39～1.52: 1450, 3, 2, 1100, 750 1.53～1.66: 1600, 4, 2, 1200, 800 1.67～1.78: 1750, 5, 2, 1300, 800 1.79～1.92: 1800, 2, 3, 1400, 900 1.93～2.06: 2000, 0, 4, 1500, 1000 2.07～2.18: 2150, 1, 4, 1600, 1050 ≥2.19: 2300, 2, 4, 1750, 1100 ○ Dosage adjustment guidelines: Patients should be carefully monitored for toxicity. Toxicity due to this medicine may be managed with symptomatic treatment, temporary interruption of treatment, and dose adjustment. Once the dose has been reduced, it should not be increased subsequently. If toxicity that the attending physician considers non-serious or non-life-threatening occurs (e.g., alopecia, taste changes, nail changes), treatment may be continued at the same dose without dose reduction or interruption. Patients should be informed that treatment may need to be discontinued immediately if moderate or severe toxicity occurs. Dose adjustment during treatment with this medicine Toxicity grade* During treatment cycle Dose adjustment for the next cycle (% of starting dose) Grade 1: Maintain dose / Maintain dose Grade 2 •First occurrence: Temporarily interrupt treatment until it resolves to Grade 0-1 / 100% •Second occurrence: Temporarily interrupt treatment until it resolves to Grade 0-1 / 75% •Third occurrence: Temporarily interrupt treatment until it resolves to Grade 0-1 / 50% •Fourth occurrence: Permanently discontinue treatment Grade 3 •First occurrence: Temporarily interrupt treatment until it resolves to Grade 0-1 / 75% •Second occurrence: Temporarily interrupt treatment until it resolves to Grade 0-1 / 50% •Third occurrence: Permanently discontinue treatment Grade 4 •First occurrence: Permanently discontinue treatment, or, if continuing treatment is considered to be in the patient's best interest, temporarily interrupt treatment until it resolves to Grade 0-1 / 50% •Second occurrence: Permanently discontinue treatment * The NCIC CTG Common Toxicity Criteria and the CTCAE of the Cancer Therapy Evaluation Program were used. Hematology: This medicine should not be taken by patients with a baseline neutrophil count below 1.5×109/L and/or a platelet count below 100×109/L. If laboratory values during a treatment cycle fall to a neutrophil count of 1.0×109/L or less or a platelet count of 75×109/L or less, treatment with this medicine should be interrupted. Dosage adjustment guidelines for toxicity when this medicine is administered in 3-week cycles in combination with other drugs: When this medicine is administered in 3-week cycles in combination with other drugs, adjustments should be made according to the dosage adjustment guidelines for this medicine and the prescribing information for the concomitant drug. - If administration of this medicine and another drug is temporarily interrupted due to toxicity occurring early in a treatment cycle, treatment should not be resumed until the requirements for resuming both the concomitant drug and this medicine are met. - If toxicity considered unrelated to this medicine occurs during a treatment cycle, administration of this medicine should continue and the dose of the other drug should be adjusted according to its prescribing information. - If treatment with the other drug is permanently discontinued, this medicine may be continued if the requirements for resuming treatment are met. The above applies to all patient groups receiving treatment for all approved indications. Dosage adjustment guidelines for toxicity when this medicine is administered continuously in combination with other drugs: When this medicine is administered continuously in combination with other drugs, the recommended dosage for toxicity should be adjusted according to the dosage adjustment guidelines for this medicine and the prescribing information for the concomitant drug. ○ Dosage and administration in special populations Patients with hepatic impairment There are insufficient safety and efficacy data on the effects of this medicine in patients with hepatic impairment, and no information is available on hepatic impairment due to cirrhosis or hepatitis. Patients with renal impairment This medicine should not be taken by patients with severe renal impairment (creatinine clearance below 30mL/min). The incidence of Grade 3 or 4 adverse reactions was found to be increased in patients with moderate renal impairment (creatinine clearance 30-50mL/min). For patients with moderate renal impairment, the dose should be reduced to 75% of 1250mg/m2; no adjustment is required for the 1000mg/m2 dose. No dose adjustment is required for patients with mild renal impairment (creatinine clearance 51-80mL/min). Patients who develop Grade 2, 3, or 4 adverse reactions during treatment should be closely monitored, and subsequent doses should preferably be adjusted with reference to the dosage adjustment guidelines for this medicine. If creatinine clearance falls below 30mL/min during treatment, this medicine should be discontinued. Dose adjustment in patients with renal impairment applies to both monotherapy and combination therapy. Older adults No dose adjustment is required when this medicine is used as monotherapy. However, the incidence of treatment-related Grade 3 or 4 adverse reactions was higher in older adults aged 60 years or older. In older adults aged 65 years or older who took this medicine in combination with other anticancer drugs, the incidence of Grade 3 or 4 adverse reactions leading to treatment discontinuation was higher. Therefore, patients aged 60 years or older should be closely monitored when treated with this medicine. - Combination therapy with docetaxel: The incidence of treatment-related Grade 3 or 4 adverse reactions and serious adverse reactions was increased in patients aged 60 years or older. When this medicine is administered in combination with docetaxel to patients aged 60 years or older, administer 75% of the dose (950mg/m2 twice daily). If no toxicity occurs at the 75% dose, the dosage may be increased to 1250mg/m2 twice daily.

Child dose

There is no experience with administration in patients under 18 years of age.

This medication may cause diarrhea, and severe diarrhea may lead to dehydration and electrolyte imbalance, requiring careful monitoring. If severe diarrhea occurs, immediately discontinue the medication and receive appropriate treatment. Symptoms of dehydration may occur; therefore, attention should be given to fluid and electrolyte supplementation when symptoms such as nausea, vomiting, or loss of appetite arise. Patients with impaired kidney function or those taking nephrotoxic drugs should take extra caution as acute renal failure may occur. It is important to test for DPD enzyme deficiency before taking this medication. Patients with DPD deficiency are at higher risk of serious side effects, necessitating dose adjustment or discontinuation. Hand and foot pain, swelling, rash, etc., may occur as hand-foot syndrome, and if the symptoms are severe, they may interfere with daily life, so consult a healthcare professional immediately if symptoms appear. Patients with a history of heart disease may experience cardiac-related side effects such as myocardial infarction, angina, or arrhythmia, so caution is warranted when administering. Patients with abnormal calcium levels may experience changes in blood calcium levels during this medication, necessitating regular checks. Patients with central nervous system or peripheral nervous system diseases should be cautious as neurological side effects may worsen. Patients with diabetes or electrolyte abnormalities should regularly monitor their condition, as symptoms may worsen due to this medication. This medication may increase the risk of bleeding when used with anticoagulants such as warfarin, so coagulation indices should be monitored frequently, and dose adjustment may be necessary. Patients with impaired liver function should have liver function thoroughly examined before administering this medication, and if liver enzyme levels rise significantly, administration should be stopped. Patients with moderate to severe impaired kidney function should be carefully administered due to a higher risk of side effects. This medication can cause serious skin reactions, so if rash or skin abnormalities occur, discontinue use immediately and consult a healthcare professional. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use effective contraception during and for a certain period after treatment. Elderly individuals may experience more severe adverse effects, so they should be monitored more closely. Symptoms such as dizziness, fatigue, and nausea may occur during the treatment, so caution is necessary when driving or operating machinery. This medication should be stored away from temperatures above 30 degrees Celsius and kept out of reach of children. It is a cytotoxic drug, so appropriate protective equipment should be used when handling. It is recommended to take this medication within 30 minutes after a meal, and if side effects occur, inform a healthcare professional immediately and receive appropriate measures.

• Diarrhea
• necrotizing enterocolitis
• dehydration
• stomatitis
• neutropenia
• neurotoxicity
• hand-foot syndrome
• myocardial infarction
• ischemia
• angina

This medication should be stored in an airtight container in a well-ventilated area, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. This manner of storage helps maintain the medication’s effectiveness for a longer time.

Appearance

Pink oblong film-coated tablet

Package unit

120 tablets (10 tablets/PTPX12)