Jelokan Tablet 150 mg (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 for this medicine is 1,250mg/㎡ twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in each 3-week cycle. When used in combination with docetaxel, the recommended dosage for this medicine is 1,250mg/m2 twice daily (approximately 12 hours apart) for 2 weeks, followed by a 1-week rest period, in each 3-week cycle; docetaxel 75mg/m2 is administered by intravenous infusion over 1 hour every 3 weeks. For metastatic colorectal cancer, when used in combination with oxaliplatin, the recommended dosage for this medicine is 1000mg/m2 twice daily for 2 weeks, followed by a 1-week rest period, in each 3-week cycle. Concomitant use with bevacizumab does not affect the initial 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, the recommended regimen is 1,250mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in each 3-week cycle, for a total of 8 cycles (24 weeks). When this medicine is used in combination with oxaliplatin, the recommended regimen is 1,000mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in each 3-week cycle. Oxaliplatin 130mg/m2 is infused intravenously over 2 hours on day 1 of each cycle, before the first dose of this medicine. A total of 8 cycles (24 weeks) is recommended. ○ Gastric cancer 1) Unresectable advanced or metastatic gastric cancer The recommended dosage for this medicine is 1,250mg/㎡ twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in each 3-week cycle. 2) First-line treatment of advanced gastric cancer in combination with platinum-based therapy The recommended regimen is to administer an initial dose of this medicine of 1,000mg/m2 twice daily for 2 weeks, followed by a 1-week rest period, in each 3-week cycle, or 625mg/m2 twice daily continuously for 3 weeks. ① When used in combination with cisplatin, the recommended dosage for this medicine is 1,000mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in each 3-week cycle; 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 for this medicine is 625mg/m2 twice daily (morning and evening) continuously for 3 weeks in each 3-week cycle; cisplatin 60mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks, and epirubicin 50mg/m2 is administered as an intravenous bolus every 3 weeks. ③ When used in combination with oxaliplatin and epirubicin, the recommended dosage for this medicine is 625mg/m2 twice daily (morning and evening) continuously for 3 weeks in each 3-week cycle; oxaliplatin 130mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks, and epirubicin 50mg/m2 is administered as an intravenous 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 for this medicine is 1000 mg/m2 orally twice daily for 2 weeks in each 3-week cycle, followed by a 1-week rest period; oxaliplatin 130 mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks. ○ Dosage modification guidelines: Monitor carefully for toxicity. Toxicity may be managed with symptomatic treatment, temporary interruption of treatment, and dose adjustment. Once the dose has been reduced, do not increase it later. If toxicity considered by the treating physician to be 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 stopped immediately if moderate or severe toxicity occurs. Grade 1: Maintain the dose during the treatment cycle; maintain the dose in the next cycle. Grade 2 first occurrence: Temporarily interrupt treatment until the toxicity resolves to grade 0-1; 100% in the next cycle; second occurrence: Temporarily interrupt treatment until the toxicity resolves to grade 0-1; 75% in the next cycle; third occurrence: Temporarily interrupt treatment until the toxicity resolves to grade 0-1; 50% in the next cycle; fourth occurrence: Permanently discontinue treatment. Grade 3 first occurrence: Temporarily interrupt treatment until the toxicity resolves to grade 0-1; 75% in the next cycle; second occurrence: Temporarily interrupt treatment until the toxicity resolves to grade 0-1; 50% in the next cycle; 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 the toxicity resolves to grade 0-1; 50% in the next cycle; second occurrence: Permanently discontinue treatment. Hematology: Patients with a baseline neutrophil count below 1.5×109/L and/or platelet count below 100×109/L should not take this medicine. 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. Patients with renal impairment: Patients with severe renal impairment (creatinine clearance less than 30mL/min) should not take this medicine. For patients with moderate renal impairment (creatinine clearance 30-50mL/min), reduce the dose to 75% of 1250mg/m2; no adjustment is required for a dose of 1000mg/m2. No dose adjustment is required for patients with mild renal impairment (creatinine clearance 51-80mL/min). Patients who experience grade 2, grade 3, or grade 4 adverse reactions during treatment should be monitored closely, and subsequent doses should preferably be adjusted according to the dosage modification guidelines for this medicine. If creatinine clearance falls below 30mL/min during treatment, this medicine should be discontinued. Children: There is no experience with administration to patients under 18 years of age. Older adults: No dose adjustment is required when this medicine is used as monotherapy. However, the incidence of treatment-related grade 3 or grade 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 agents, the incidence of grade 3 or grade 4 adverse reactions resulting in treatment discontinuation was higher. Therefore, patients aged 60 years or older receiving this medicine should be monitored closely. Combination therapy with docetaxel: When this medicine is administered in combination with docetaxel to patients aged 60 years or older, administer at 75% of the dose (950mg/m2 twice daily). If no toxicity occurs at the 75% dose, the dose may be increased to 1250mg/m2 twice daily.

This medication can cause diarrhea, and in some cases, very severe diarrhea may occur. If diarrhea worsens, treatment should be stopped immediately, and appropriate care is necessary. Dehydration may occur, so it is essential to prevent dehydration, and if it occurs, immediate fluid and electrolyte replacement is necessary. Patients with certain enzyme deficiencies may experience severe side effects, so it is important to check for enzyme deficiency before using this medication. Hand and foot syndrome may occur, presenting with pain, swelling, rashes, etc. If symptoms are severe, treatment should be stopped or the dosage reduced. Patients with heart disease may be at risk of cardiac side effects and should be observed closely. There may be variations in calcium levels, so caution is needed in patients with hypocalcemia or hypercalcemia. Patients with central nervous system or peripheral nerve diseases require caution due to the possibility of neurological side effects. Patients with diabetes or electrolyte imbalances should be cautious, as symptoms may worsen. This medication may interact with certain anticoagulants or anticonvulsants, so close monitoring such as blood tests is necessary when taken together. Patients with impaired liver or kidney function are at a higher risk of side effects from this medication, so dosage adjustments and careful monitoring are needed. Severe skin reactions may occur, so if skin abnormalities appear, treatment should be stopped immediately. Pregnant or breastfeeding women should not take this medication as it may harm the fetus or newborn. Safety in children has not been established, therefore it should not be administered to patients under 18 years old. Elderly patients may experience more severe side effects, requiring closer monitoring. If dizziness, fatigue, nausea, or other symptoms occur during treatment, it is advisable to avoid driving or operating machinery. This medication should not be stored at temperatures above 30 degrees Celsius and must be kept out of reach of children. Patients should be fully aware of the potential for side effects and how to respond if symptoms arise, and should consult healthcare professionals immediately if any abnormal symptoms occur.

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

This medication should be stored in a sealed container to prevent air from entering, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's effectiveness and safety.

Appearance

Pale pink oval film-coated tablet

Package unit

60 tablets (10 tablets/PTP) x 6