Gelcatabin 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, and docetaxel 75mg/m2 is administered by intravenous injection 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. 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 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 regimen 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 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 The recommended regimen is an initial dose of this medicine 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 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. ○ Dose calculation based on body surface area (1250mg/m2) 1250mg/m2 per dose (twice daily), number of tablets to take per dose (morning, evening), 1250mg/m2, (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), number of tablets to take per dose (morning, evening), 1000mg/m2, (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 associated with 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 considered by the attending physician to be non-serious or non-life-threatening (e.g., alopecia, taste alteration, nail changes) occurs, 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. 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 reduced to Grade 0-1 | 100% ∙Second occurrence | Temporarily interrupt treatment until reduced to Grade 0-1 | 75% ∙Third occurrence | Temporarily interrupt treatment until reduced to Grade 0-1 | 50% ∙Fourth occurrence | Permanently discontinue treatment Grade 3 ∙First occurrence | Temporarily interrupt treatment until reduced to Grade 0-1 | 75% ∙Second occurrence | Temporarily interrupt treatment until reduced to Grade 0-1 | 50% ∙Third occurrence | Permanently discontinue treatment Grade 4 ∙First occurrence | Permanently discontinue treatment, or temporarily interrupt treatment until reduced 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 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 discontinued. 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, dose adjustments should be made in accordance with the dosage adjustment guidelines for this medicine and the prescribing information for the concomitant drug. - If treatment with 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, treatment with this medicine should continue, and the dose of the other drug should be adjusted in accordance with its prescribing information. - If treatment with the other drug is permanently discontinued, treatment with this medicine may continue if the criteria for resuming treatment are met. The above applies to all patient populations treated for all approved indications. Dosage adjustment guidelines based on 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 based on toxicity should be adjusted in accordance with 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 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). 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 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 decreases to less than 30mL/min during treatment, this medicine should be discontinued. Dose adjustment in 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 Grade 4 adverse reactions was higher in elderly patients aged 60 years or older. ◆ In elderly patients 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 receiving this medicine should be closely monitored. - 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 at 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, which can sometimes be severe, thus hydration and electrolyte supplementation may be necessary to prevent dehydration if diarrhea is severe. As dehydration can occur during treatment, symptoms of dehydration should be treated immediately, and caution is required for patients with impaired kidney function as the risk of renal failure is increased. This medication can cause serious side effects in patients with certain enzyme deficiencies, making it important to test for enzyme deficiencies before use. Hand-and-foot syndrome may occur, which could manifest as pain, swelling, or rash in the hands and feet, and if symptoms worsen, the medication should be discontinued or the dosage reduced. Patients with a history of heart disease should be cautious as heart-related side effects such as myocardial infarction, angina, or arrhythmia may occur. Patients with abnormal calcium levels should exercise additional caution when taking this medication, and patients with central or peripheral nervous system disorders should be treated carefully. Patients with diabetes or electrolyte abnormalities should be aware that their condition may worsen with this medication. This medication may alter the effects of specific drugs like warfarin or phenytoin, so careful monitoring through blood tests is necessary when taken together. Patients with impaired liver or kidney function should consult a doctor before taking this medication and should stop taking it if liver function tests are significantly elevated. This medication may cause serious skin reactions. If any abnormal skin symptoms occur, it is crucial to inform a doctor immediately. Pregnant or breastfeeding women should not take this medication, and women and men of childbearing age should use effective contraception during and for some time after treatment. Elderly patients should be monitored more closely for side effects, as they may experience more severe reactions to this medication. Overdose may result in symptoms such as nausea, vomiting, diarrhea, bone marrow suppression, requiring immediate medical attention. Patients should refrain from driving or operating machinery if experiencing dizziness or fatigue during treatment. This medication should not be stored above 30 degrees Celsius and should be kept out of reach of children, with safe handling and disposal required. Patients should receive sufficient guidance regarding potential side effects from this medication and the appropriate responses to them, particularly if symptoms such as diarrhea, nausea, vomiting, or hand-and-foot syndrome occur, and should consult a doctor immediately in such cases.

• Diarrhea
• necrotizing enterocolitis
• dehydration
• nausea
• vomiting
• stomatitis
• neutropenia
• neurotoxicity
• hand-foot syndrome
• myocardial infarction

This medication should be stored in a tightly sealed container to prevent air exposure and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy.

Appearance

Pink oval film-coated tablet

Package unit

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