Jelobic 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 a 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 dose and administration of this medicine is 1,250mg/㎡ twice daily (morning and evening), at a dose of 1,250mg/㎡ each time, taken orally for 2 weeks followed by a 1-week rest period, in 3-week cycles. When used in combination with docetaxel, the recommended dose and administration 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, and 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 according to the prescribing information for docetaxel. For metastatic colorectal cancer, when used in combination with oxaliplatin, the recommended dose and administration of this medicine is 1000mg/m2 twice daily for 2 weeks, followed by a 1-week rest period, in 3-week cycles. When used in combination with bevacizumab, the initial dose of this medicine is not affected. As adjuvant therapy after surgery for stage III(Dukes‘ C) colon cancer, administer as follows. When this medicine is administered as monotherapy, it is recommended that 1,250mg/m2 be taken orally 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 that 1,000mg/m2 of this medicine be taken orally twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in 3-week cycles, and that oxaliplatin 130mg/m2 be administered by intravenous infusion over 2 hours 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, it is recommended that antiemetics and premedication be given before oxaliplatin administration according to the prescribing information for oxaliplatin. ○ Gastric cancer 1) Unresectable advanced or metastatic gastric cancer The recommended dose and administration of this medicine is 1,250mg/㎡ twice daily (morning and evening), at a dose of 1,250mg/㎡ each time, taken orally 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 that the initial dose of this medicine be administered either at 1,000mg/m2 twice daily for 2 weeks followed by a 1-week rest period, in 3-week cycles, or at 625mg/m2 twice daily continuously for 3 weeks. When this medicine is used in combination with cisplatin, premedication should be given before cisplatin administration according to the prescribing information for cisplatin. ① When used in combination with cisplatin, the recommended dose and administration 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, and 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 dose and administration 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 dose and administration 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 therapy after surgery for stage Ⅱ, Ⅲ gastric cancer, the recommended dose and administration of this medicine is 1000 mg/m2 orally twice daily for 2 weeks, followed by a 1-week rest period, in 3-week cycles, and 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 be taken at each dose. Dose calculation based on body surface area (1250mg/m2) 1250mg/m2 per dose (twice daily), (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), (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 administration of 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 treating physician considers non-serious or non-life-threatening occurs (e.g., alopecia, taste changes, nail changes), treatment may continue 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 administration of 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: 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, administration of this medicine should be stopped. Dose adjustment guidelines according to toxicity when this medicine is administered in combination with other drugs in 3-week cycles: When this medicine is administered in combination with other drugs in 3-week cycles, adjust the dose according to the dose adjustment guidelines for this medicine and the 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, continue administering this medicine and adjust the dose of the other drug according to its prescribing information. - If treatment with the other drug is permanently discontinued, administration of this medicine may continue if the criteria for resuming treatment are met. The above applies to all patient groups receiving treatment for all approved indications. Dose adjustment guidelines according to 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 dose and administration according to toxicity should be adjusted according to the dose 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 administering this medicine to 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 Grade 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, reduce the dose 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, Grade 3, or Grade 4 adverse reactions during treatment should be carefully monitored, and subsequent doses should preferably be adjusted by referring to the dose adjustment guidelines for this medicine. If creatinine clearance falls below 30mL/min during treatment, administration of this medicine should be stopped. 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 Grade 4 adverse reactions was higher in older adults aged 60 years or older. ◆ Since the incidence of Grade 3 or Grade 4 adverse reactions leading to treatment discontinuation was higher in older adults aged 65 years or older who took this medicine in combination with other anticancer agents, patients aged 60 years or older should be carefully monitored when given this medicine. - Combination therapy with docetaxel: The incidence of treatment-related Grade 3 or Grade 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 dose 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, which can sometimes be severe, and you should immediately consult a doctor if it worsens. Severe diarrhea can lead to dehydration, so fluid and electrolyte replenishment is necessary. This medication can cause dehydration, thus patients with dehydration symptoms should be particularly careful, and patients with weak renal function are at risk for acute renal failure. Patients with DPD enzyme deficiency may exhibit severe toxicity when taking this medication, so they should be tested in advance. Hand and foot syndrome, characterized by pain or swelling in the hands and feet and changes in the skin, may occur, and in severe cases, it can interfere with daily life. This medication may affect the heart, so patients with a history of heart disease should be cautious. Calcium levels may be abnormal, and patients with issues related to calcium concentration should be cautious during use. Patients with central nervous system or peripheral nervous system diseases may experience worsening neurological symptoms when taking this medication, so vigilance is required. Patients with diabetes or electrolyte abnormalities should be careful, as their conditions may worsen during treatment. This medication may interact with anticoagulants like warfarin or phenytoin, necessitating frequent blood tests if taken together. Patients with impaired liver function should closely monitor their liver function before and after taking this medication, and it should be avoided in cases of severe liver damage. Patients with moderate or greater impairment of kidney function may have higher risk of side effects when taking this medication. This medication can rarely cause serious skin reactions, so any unusual skin symptoms should lead to immediate discontinuation. It should not be administered to patients with allergies to capecitabine or its additives, pregnant or breastfeeding women, or patients with severe renal failure. It must be taken according to a doctor's instructions, and any adverse reactions should be immediately reported to healthcare professionals. There may be dizziness or fatigue while driving or operating machinery during treatment, so caution is advised. Store this medication in a cool place below 30 degrees Celsius and out of the reach of children. Patients and caregivers must be thoroughly informed of the side effects and precautions when taking this medication, and they should inform health professionals immediately if any side effects arise.

• Diarrhea
• dehydration
• stomatitis
• neutropenia
• neurotoxicity
• hand-foot syndrome
• myocardial infarction
• angina pectoris
• arrhythmia
• cardiogenic shock

This medication should be kept in a sealed container to prevent air from entering and is best stored at room temperature between 1 and 30 degrees Celsius. This helps to maintain the medication's efficacy and prevent degradation.

Appearance

Pink oval film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTP) × 6], 120 tablets/box [(10 tablets/PTP) × 12]