TS-ONE Dosage/Direction for Use

The initial recommended dose of TS-ONE when given as monotherapy or combination therapy is provided as follows. The dose can be decreased according to the patient's tolerance to the medication. (See Tables 6 and 7.)

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Monotherapy: TS-ONE should be administered twice daily, after breakfast and after the evening meal, for 28 consecutive days, followed by a 14-day rest. This is regarded as one course of the regimen. When used for postoperative adjuvant chemotherapy, the maximum treatment duration is 1 year for gastric cancer and 6 months for pancreatic cancer and biliary tract cancer.
Combination Therapy: Gastric Cancer: TS-ONE with cisplatin: TS-ONE is recommended to be administered twice daily, after meals, for 21 consecutive days and 60 mg/m² intravenous infusion of cisplatin on Day 8, followed by a 14-day rest. This treatment is repeated every 5 weeks.
TS-ONE with docetaxel: TS-ONE is recommended to be administered twice daily, after meals, for 14 consecutive days and intravenous infusion of docetaxel (40 mg/m² body surface area) on Day 1, followed by a 7-day rest. This treatment is repeated every 3 weeks.
When used for postoperative adjuvant chemotherapy, administer TS-ONE monotherapy on days 1 to 14 of a 3-week cycle during the first course. During the second to seventh courses, administer TS-ONE in combination with docetaxel. After the eighth course, continue treatment with TS-ONE monotherapy on days 1 to 28 of 6-week cycles for up to 1 year.
TS-ONE with oxaliplatin: TS-ONE is recommended to be administered twice daily, after meals, for 14 consecutive days and intravenous infusion of oxaliplatin (130 mg/m² in the adjuvant setting; 100 mg/m² in the advanced setting) on Day 1, followed by a 7-day rest. This treatment is repeated every 3 weeks.
When used for postoperative adjuvant chemotherapy, the maximum treatment duration is 6 months.
Non-Small Cell Lung Cancer: TS-ONE with carboplatin: TS-ONE is recommended to be administered twice daily, after meals, for 14 consecutive days, in combination with carboplatin (AUC 5) on Day 1, followed by a 7-day rest. This treatment is repeated every 3 weeks.
TS-ONE with cisplatin: TS-ONE is recommended to be administered twice daily, after meals, for 21 consecutive days and 60 mg/m² intravenous infusion of cisplatin on Day 8, followed by a 14-day rest. This treatment is repeated every 5 weeks.
Colorectal Cancer: For first-line treatment, TS-ONE is recommended to be administered twice daily, after meals, for 14 consecutive days, in combination with oxaliplatin 130 mg/m² on Day 1 as a 2-hour intravenous infusion, followed by a 7-day rest. This treatment is repeated every 3 weeks.
For second-line treatment, TS-ONE is recommended to be administered twice daily, after meals, from Day 1 to 14, in combination with irinotecan 125 mg/m² on Days 1 and 15, followed by a 14-day rest. This treatment is repeated every 4 weeks.
Biliary Tract Cancer: TS-ONE with gemcitabine and cisplatin: TS-ONE is recommended to be administered twice daily, after meals, for 7 consecutive days and intravenous infusion of 1,000 mg/m² gemcitabine and 25 mg/m² cisplatin on day 1, followed by a 7-day rest. This treatment is repeated every 2 weeks. Initial TS-ONE dose is as per Table 6.
TS-ONE with gemcitabine: TS-ONE is recommended to be administered twice daily, after meals, for 14 consecutive days and intravenous infusion of 1,000 mg/m² gemcitabine on days 1 and 8, followed by a 7-day rest. This treatment is repeated every 3 weeks. Initial TS-ONE dose is as per Table 7.
Use in the Elderly: Since elderly patients often have decreased physiological functions, TS-ONE should be administered with care.
Pediatric Use: The safety of TS-ONE in low birth weight infants, neonates, infants or children has not been established. [There is no clinical data. When TS-ONE must be administered to children, special attention must be paid to the development of adverse reactions, taking the effect of TS-ONE on the gonads into account.]