Gelodav 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 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 intravenously 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 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. 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 to administer 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, it is recommended to administer this medicine at 1,000mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 1-week rest period, in 3-week cycles, and to infuse oxaliplatin intravenously at 130mg/m2 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, administration of antiemetics 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 It is recommended 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 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 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, 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 dosage of this medicine is 625mg/m2 twice daily (morning and evening) continuously for 3 weeks, in 3-week cycles, and 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, and 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, and oxaliplatin 130 mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks. Dose calculation based on body surface area (1250mg/m2), dose per administration 1250mg/m2 (twice daily), number of tablets to take per dose (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 based on body surface area (1000mg/m2), dose per administration 1000mg/m2 (twice daily), number of tablets to take per dose (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 signs of toxicity. Toxicity due to 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 considered by the treating physician to be non-serious or non-fatal (e.g., alopecia, taste changes, nail changes) occurs, treatment may continue 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. Dosage adjustment for administration of this medicine: Toxicity grade*, during treatment cycle, dose adjustment for next cycle (% of starting dose). Grade 1: Maintain dose, maintain dose. Grade 2: First occurrence, temporarily interrupt treatment until toxicity resolves to Grade 0-1, 100%; second occurrence, temporarily interrupt treatment until toxicity resolves to Grade 0-1, 75%; third occurrence, temporarily interrupt treatment until toxicity resolves to Grade 0-1, 50%; fourth occurrence, permanently discontinue treatment. Grade 3: First occurrence, temporarily interrupt treatment until toxicity resolves to Grade 0-1, 75%; second occurrence, temporarily interrupt treatment until toxicity resolves to Grade 0-1, 50%; third occurrence, permanently discontinue treatment. Grade 4: First occurrence, permanently discontinue treatment or, if continuation of treatment is considered to be in the patient's best interest, temporarily interrupt treatment until toxicity 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, during a treatment cycle, laboratory values 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 interrupted. 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, adjust the dosage in accordance with 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 because of toxicity occurring early in the treatment cycle, treatment should not be resumed until the criteria for resuming both the concomitant drug and this medicine are met. - If toxicity not considered to be associated with this medicine occurs during a treatment cycle, continue administering this medicine and adjust the dose of the other drug in accordance with 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 populations treated for all approved indications. 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 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 administering this medicine to patients with hepatic impairment, and no information is available regarding 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. An increased incidence of Grade 3 or 4 adverse reactions was observed 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 develop 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 below 30mL/min during treatment, administration of 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 necessary 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. ◆ Because the incidence of Grade 3 or 4 adverse reactions leading to treatment discontinuation was higher in patients aged 65 years or older who received this medicine in combination with other anticancer drugs, patients aged 60 years or older should be closely monitored when this medicine is administered. - 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 drug may cause diarrhea upon administration, and severe diarrhea may occasionally occur, requiring caution. If severe diarrhea occurs, rehydration and electrolyte supplementation may be necessary to prevent dehydration. If symptoms of dehydration appear during treatment, immediate medical attention is required, especially for patients with impaired renal function or those taking nephrotoxic medications, as they may be at risk for acute renal failure. This medication can cause severe toxicity in patients deficient in a specific enzyme, DPD, so it is important to test for DPD deficiency before use. Symptoms such as pain, swelling, and erythema in the hands and feet can occur, known as hand-foot syndrome, and if these symptoms worsen, discontinuation or dosage adjustment may be necessary. Cardiac-related side effects such as angina, arrhythmias, and heart failure have been reported, thus patients with a history of heart disease require special caution. Patients with abnormal calcium levels should be administered this drug carefully, and those with central nervous system or peripheral nervous system disorders should also be cautious. Patients with diabetes or electrolyte disturbances may experience worsening symptoms while taking this medication, requiring close monitoring. This drug may interact with specific anticoagulants, such as warfarin, so when used concurrently, the blood coagulation status must be frequently monitored and the dosage adjusted. Patients with impaired liver or kidney function must be closely monitored before and after administration of this drug, and if functional deterioration occurs, the use or dosage should be adjusted accordingly. This drug can cause severe skin reactions, and if rashes or blisters occur, patients should consult a physician immediately. Pregnant or breastfeeding women should not take this medication, and women and men of childbearing age should use effective contraception during treatment. The safety and efficacy of this drug in patients under 18 years of age have not been established. Elderly patients may experience more severe side effects than younger patients and should be observed more closely while taking it. In cases of overdose, symptoms such as nausea, vomiting, diarrhea, and bone marrow suppression may occur, and appropriate treatment is necessary based on the symptoms. If dizziness or fatigue occurs during treatment, patients should refrain from driving or operating machinery. This drug should not be stored above 30 degrees Celsius and must be kept out of reach of children, as it is a cytotoxic medication requiring special caution during handling. Patients and caregivers should be thoroughly informed about potential side effects and management strategies, and prompted to consult medical personnel immediately if abnormal symptoms arise.

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

This medication is sensitive to air and moisture, so it must be stored in a sealed container in its original packaging. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the drug's effectiveness for an extended period.

Appearance

Pale pink oval film-coated tablet

Package unit

60 tablets (10 tablets/PTP packaging x 6)