Jalbo Binjeong 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 a 3-week cycle. 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 a 3-week cycle; docetaxel 75mg/m2 is administered by intravenous infusion 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 a 3-week cycle. When used in combination with bevacizumab, the initial dose of this medicine is not affected. For 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 a 3-week cycle, 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 a 3-week cycle; 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, for a total of 8 cycles (24 weeks). When this medicine is used in combination with oxaliplatin, it is recommended to administer antiemetics and premedication before oxaliplatin administration 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 a 3-week cycle. 2) First-line treatment of advanced gastric cancer in combination with a platinum-based regimen The recommended dosage is an initial dose of this medicine of 1,000mg/m2 twice daily for 2 weeks, followed by a 1-week rest period, in a 3-week cycle, 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 a 3-week cycle; 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 a 3-week cycle; cisplatin 60mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks, and epirubicin 50mg/m2 is administered as an intravenous 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 a 3-week cycle; oxaliplatin 130mg/m2 is administered by intravenous infusion over 2 hours every 3 weeks, and epirubicin 50mg/m2 is administered as an intravenous 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 a 3-week cycle; 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 with each dose. Dose calculation by body surface area (1250mg/m2) 1250mg/m2 per dose (twice daily) 1250mg/m2 Number of tablets to take each time (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) 1000mg/m2 Number of tablets to take each time (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 modification 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 modification. Once the dose has been reduced, it should not subsequently be increased. If toxicity is considered by the attending physician to be non-serious or non-life-threatening (e.g., alopecia, taste changes, 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. Dosage modifications during treatment with this medicine Toxicity grade* During the treatment cycle Dose modification for the next cycle (% of starting dose) Grade 1 Maintain the dose Maintain the dose Grade 2 •First occurrence Temporarily interrupt treatment until the toxicity resolves to Grade 0-1 100% •Second occurrence Temporarily interrupt treatment until the toxicity resolves to Grade 0-1 75% •Third occurrence Temporarily interrupt treatment until the toxicity resolves to Grade 0-1 50% •Fourth occurrence Permanently discontinue treatment Grade 3 •First occurrence Temporarily interrupt treatment until the toxicity resolves to Grade 0-1 75% •Second occurrence Temporarily interrupt treatment until the toxicity 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 the toxicity resolves to Grade 0-1 50% •Second occurrence Permanently discontinue treatment * The general toxicity criteria of NCIC CTG 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, 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 discontinued. Dosage modification guidelines for toxicity when this medicine is administered in combination with other drugs in a 3-week cycle: When this medicine is administered in combination with other drugs in a 3-week cycle, dose modifications should be made according to the dosage modification 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 requirements for resuming both the concomitant drug and this medicine are met. - If toxicity considered unrelated to this medicine occurs during a treatment cycle, administration of this medicine should continue and the dose of the other drug should be modified in accordance with its prescribing information. - If treatment with the other drug is permanently discontinued, administration of this medicine may continue if the requirements for resuming treatment are met. The above applies to all patient groups receiving treatment for all approved indications. Dosage modification 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 modified according to the dosage modification guidelines for this medicine and the prescribing information for the concomitant drug. ○ Dosage in special populations Patients with hepatic impairment There are insufficient safety and efficacy data regarding 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 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, the dose should be reduced 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 by referring to the dosage modification guidelines for this medicine. If creatinine clearance falls below 30mL/min during treatment, administration of 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 necessary when this medicine is used as monotherapy. However, the incidence of treatment-related Grade 3 or Grade 4 adverse reactions was higher in patients aged 60 years or older. ◆ Because the incidence of Grade 3 or Grade 4 adverse reactions resulting in treatment discontinuation was higher in patients aged 65 years or older who took 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 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 to patients under 18 years of age.

This medication may cause diarrhea, and severe diarrhea poses a risk of dehydration, necessitating careful monitoring. If dehydration occurs, fluid and electrolyte replacement may be required. This medication can cause dehydration, so preventing and promptly treating dehydration is crucial for patients experiencing anorexia, weakness, nausea, vomiting, or diarrhea. Special caution is required if used in patients with compromised renal function or concurrently with nephrotoxic drugs due to increased risk of renal failure. Some patients may experience severe toxicity due to DPD enzyme deficiency; therefore, testing for the enzyme's activity is recommended. Patients with DPD deficiency should not use this medication or may require dose adjustments. Symptoms of hand-foot syndrome, including pain, swelling, and rash on the hands and feet, may occur. If symptoms are severe, drug administration should be discontinued or dosage reduced. Vitamin B6 administration is not recommended for the prevention of hand-foot syndrome, while the use of dexpanthenol may be beneficial. Patients with a history of heart disease may experience cardiac-related side effects such as angina, arrhythmia, or heart failure, requiring caution. Patients with hypocalcemia or hypercalcemia should use this medication carefully as their conditions may worsen. Patients with a history of central or peripheral nervous system issues may have worsened neurological symptoms when using this medication, requiring close monitoring. Patients with diabetes or electrolyte disturbances may experience exacerbation of symptoms when taking this medication, warranting monitoring. This medication can interact with anticoagulants like warfarin or phenytoin, so blood tests and monitoring of drug concentrations are necessary when taken together. Patients with impaired liver function may experience deterioration in liver function from this medication; therefore, frequent liver function tests should be conducted, and administration should be ceased if liver enzyme levels are elevated. Patients with moderate renal impairment are at a heightened risk for serious side effects and require dosage adjustments and careful monitoring. This medication can cause severe skin reactions, so administration should be stopped immediately if skin rashes or blisters occur. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing age must use effective contraception during treatment and for some time afterwards. Use in children under 18 years is not recommended as safety and efficacy in this age group have not been established. Elderly patients may experience more severe side effects from this medication, necessitating closer observation. Overdose may result in symptoms including nausea, vomiting, diarrhea, and bone marrow suppression, and medical personnel should be consulted immediately if these symptoms occur. While taking this medication, if dizziness, fatigue, or nausea occurs, it is safer to avoid driving or operating machinery. This medication should not be stored at temperatures above 30 degrees Celsius and should be kept out of reach of children. Additionally, safety equipment should be worn when handling the medication and disposal procedures should be followed.

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

This medication should be stored in a tightly closed container to prevent the ingress of air or moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage helps to retain the medication's effectiveness for a longer duration.

Appearance

Light pink oval film-coated tablet

Package unit

60 tablets (10 tablets/PTP*6)