Gelocan 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 infusion over 1 hour every 3 weeks. When this medicine is used in combination with docetaxel, premedication must be given before docetaxel administration according to 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. When used in combination with bevacizumab, the initial dose of this medicine is not affected. For adjuvant treatment after surgery for stage III (Dukes‘ C) colon cancer, administer as follows. When this medicine is administered as monotherapy, the recommended dosage is 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, the recommended dosage is 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, administration of antiemetics and premedication before oxaliplatin is recommended according to the 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 initial 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 according to 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 therapy 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 and the number of tablets to be taken at each dose according to body surface area. Dose calculation by body surface area (1250mg/m2) 1250mg/m2 per dose (twice daily) Number of tablets to take per dose at 1250mg/m2 (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 by body surface area (1000mg/m2) 1000mg/m2 per dose (twice daily) Number of tablets to take per dose at 1000mg/m2 (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 caused by this medicine may be managed with symptomatic treatment, temporary interruption of treatment, and dose adjustment. Once the dose has been reduced, it should not subsequently be increased. If toxicity considered by the attending physician to be non-serious or nonfatal occurs (e.g., alopecia, taste alteration, 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 interrupted 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 temporarily interrupt treatment until it resolves to Grade 0-1 if continuing treatment is considered to be in the patient's best interest / 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 a 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. Dosage adjustment guidelines based on 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 dosage according to the dosage 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 resumption criteria for both the concomitant drug and this medicine are met. - If toxicity considered unrelated to this medicine occurs during a treatment cycle, continue this medicine and adjust the dose of the other drug according to its prescribing information. - If treatment with the other drug is permanently discontinued, this medicine may be continued if the criteria for resuming treatment are met. The above applies to all patient groups receiving treatment for all approved indications. Dosage adjustment guidelines based on toxicity when this medicine is administered in continuous therapy in combination with other drugs: When this medicine is administered in continuous therapy in combination with other drugs, the recommended dosage based on toxicity should be adjusted according to the dosage adjustment guidelines for this medicine and the prescribing information for the concomitant drug. ○ Dosage in special patient 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 less than 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). For patients with moderate renal impairment, reduce the dose to 75% of 1250mg/m2; no adjustment is needed for the 1000mg/m2 dose. No dose adjustment is needed 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 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 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 drugs, the incidence of Grade 3 or Grade 4 adverse reactions leading to treatment discontinuation was higher; therefore, patients aged 60 years or older should be closely monitored when receiving 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 drug can cause diarrhea, which can sometimes be very severe; if diarrhea worsens, treatment should be stopped immediately and appropriate care should be sought. Dehydration symptoms may occur, so it is important to prevent or promptly treat dehydration in case of vomiting or diarrhea, and patients with weakened kidney function should be especially careful. Patients with a deficiency of the enzyme DPD, which breaks down this drug, have a higher risk of severe side effects; thus, it is recommended to test for DPD deficiency before administering. Hand and foot syndrome, characterized by pain in the hands and feet, rash, and swelling may occur; if symptoms are severe, treatment should be stopped or dosage should be reduced. This drug may burden the heart, so patients with a history of heart disease should be cautious, as symptoms such as myocardial infarction, angina, or arrhythmia may appear. Patients with abnormal calcium levels should be careful when taking this drug, as well as those with central nervous system or peripheral nervous system disorders. Patients with diabetes or electrolyte abnormalities may find their conditions worsen while taking this medicine, so caution is needed. When this drug is taken together with anticoagulants such as warfarin, the risk of bleeding may increase; therefore, it is important to frequently check coagulation status and adjust dosages. Patients with impaired liver or kidney function face a higher risk of side effects from this drug, necessitating regular testing, and treatment should be stopped in case of severe damage. Severe skin reactions may occur, so if skin rashes, blisters, or erythema worsen, treatment should be stopped immediately. Women who are pregnant or breastfeeding should not use this drug, and women of childbearing age should avoid pregnancy during and for a certain period after taking this medicine. Elderly patients may experience more severe side effects, so careful monitoring is essential. Overdosage may result in nausea, vomiting, diarrhea, and bone marrow suppression, so the prescribed dosage must be strictly followed. If symptoms such as dizziness or fatigue occur during treatment, it is advisable to avoid driving or operating machinery.

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

This medication should be stored in a sealed container to prevent air exposure, and it is best to store it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy and ensures safe use.

Appearance

Pale pink oval film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6), 120 tablets (10 tablets/PTP x 12)