Jeloda Tablet 500 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 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 by intravenous injection over 1 hour every 3 weeks. When this medicine is used in combination with docetaxel, premedication must be given before docetaxel administration in accordance with the approved 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 administered as monotherapy, this medicine is recommended at 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, this medicine is administered 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 at 130mg/m2 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. When this medicine is used in combination with oxaliplatin, it is recommended that antiemetics and premedication be given before oxaliplatin administration in accordance with the approved prescribing information for oxaliplatin. ○ Gastric cancer 1) Inoperable 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 The recommended starting dose of this medicine is 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 must be given before cisplatin administration in accordance with the approved 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 in 3-week cycles, followed by a 1-week rest period; oxaliplatin 130 mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks. ○ 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 dosage adjustment. Once the dose has been reduced, it should not subsequently be increased. If toxicity that the treating physician considers non-serious or non-life-threatening occurs (e.g., alopecia, taste alteration, nail changes), treatment may continue at the same dose without dose reduction or treatment interruption. Patients should be informed that treatment may need to be stopped immediately if moderate or severe toxicity occurs. Dosage 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 continuation 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 Hematologic: 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 fall to a neutrophil count of 1.0×109/L or less or a platelet count of 75×109/L or less during a treatment cycle, this medicine should be discontinued. 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, dosage should be adjusted according to the dosage adjustment guidelines for this medicine and the approved prescribing information for the concomitant drug. If administration of this medicine and the other drug is temporarily interrupted due to toxicity occurring early in a treatment cycle, treatment should not be resumed until the criteria for resuming both the concomitant drug and this medicine are met. If toxicity considered unrelated to this medicine occurs during a treatment cycle, this medicine should be continued and the dose of the other drug should be adjusted in accordance with its approved prescribing information. If treatment with the other drug is permanently discontinued, this medicine may be continued if the criteria for resuming treatment are met. 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 approved prescribing information for the concomitant drug. ○ Dosage 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 Patients with severe renal impairment (creatinine clearance below 30mL/min) should not take this medicine. 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). In patients with moderate renal impairment, reduce the dose to 75% of 1250mg/m2; no adjustment is required for the 1000mg/m2 dose. No dose adjustment is required in 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 by referring to the dosage adjustment guidelines for this medicine. If creatinine clearance falls below 30mL/min during treatment, this medicine should be discontinued. Dose adjustment for patients with renal impairment applies to both monotherapy and combination therapy. Elderly patients 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 patients aged 60 years or older. In patients 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 receiving this medicine should be closely monitored. Combination therapy with docetaxel: The incidence of treatment-related Grade 3 or 4 adverse reactions and serious adverse reactions 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 can cause diarrhea, and in severe cases, it may lead to dehydration; therefore, careful monitoring is necessary. Severe diarrhea may require fluid and electrolyte replenishment. Additionally, if dehydration symptoms appear during this medication, immediate treatment is required, especially in patients with poor kidney function, where there is a risk of renal failure. This medication can cause serious toxicity in patients with DPD enzyme deficiency, so it is crucial to test for DPD deficiency before use. Hand and foot syndrome may occur manifesting as pain or swelling in the hands and feet; if symptoms are severe, the administration of the drug should be halted or dosage adjusted. Patients with heart disease or issues related to heart function should exercise caution, as there is a risk of cardiac toxicity while using this drug. Patients with abnormal calcium levels need to be more cautious when taking this medication, and careful use is also required in patients with central or peripheral nervous system diseases. Those with diabetes or electrolyte imbalances may experience worsening conditions while on this medication, thus caution is necessary. This drug may interact when used concurrently with anticoagulants such as warfarin or phenytoin, so careful monitoring through blood tests is required during treatment. Patients with impaired liver or kidney function should consult a doctor for appropriate dosage adjustments before taking this drug. There may be severe skin reactions, so if any abnormal skin symptoms occur, it is essential to inform healthcare personnel immediately. Pregnant or breastfeeding women should avoid taking this medication, and fertile women and men must practice effective contraception during and for a period after treatment. Elderly patients may exhibit more severe side effects, thus close monitoring is needed. Dizziness or fatigue may occur with this medication, requiring attention when driving or operating machinery. The safety and efficacy of this drug have not been established in children, and it should only be taken under the prescription and guidance of an experienced physician. It is important to consult with medical personnel immediately if side effects arise.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1°C and 30°C. Additionally, because moisture can reduce the drug's effectiveness, it is essential to keep it in its original packaging.

Appearance

Pink oval film-coated tablet

Package unit

120 tablets (10 tablets/PTP packaging x 12)