TS-ONE

Adults w/ adjuvant & advanced gastric, pancreatic & biliary tract cancer; advanced NSCLC; locally advanced or unresectable or metastatic CRC in combination w/ oxaliplatin as 1st-line treatment or in combination w/ irinotecan as 2nd-line treatment; metastatic HER-2 -ve breast cancer as monotherapy.

Initial dose: Monotherapy or combination therapy except for biliary tract cancer when combined w/ gemcitabine Adult w/ BSA ≥1.5 m² 60 mg bid, 1.25 to <1.5 m² 50 mg bid, <1.25 m² 40 mg bid. Monotherapy: Administer bid for 28 consecutive days, followed by 14-day rest. Max treatment duration as post-op adjuvant chemotherapy: 1 yr for gastric cancer, 6 mth for pancreatic & biliary tract cancer. Gastric cancer Combination w/ cisplatin: Administer bid for 21 consecutive days & cisplatin 60 mg/m² IV infusion on day 8, followed by 14-day rest. Repeat every 5 wk. Combination w/ docetaxel: Administer bid for 14 consecutive days & docetaxel 40 mg/m² IV infusion on day 1, followed by 7-day rest. Repeat every 3 wk. Post-op adjuvant chemotherapy: Administer as monotherapy on days 1-14 of 3-wk cycle (1st course), then w/ docetaxel for 2nd-7th courses. After the 8th course, continue as monotherapy on days 1-28 of 6-wk cycles for up to 1 yr. Combination w/ oxaliplatin: Administer bid for 14 consecutive days & oxaliplatin 130 mg/m² IV infusion in adjuvant setting; 100 mg/m² in advanced setting on day 1, followed by 7-day rest. Repeat every 3 wk. Max treatment duration as post-op adjuvant chemotherapy: 6 mth. NSCLC Combination w/ carboplatin: Administer bid for 14 consecutive days & carboplatin AUC 5 on day 1, followed by 7-day rest. Repeat every 3 wk. Combination w/ cisplatin: Administer bid for 21 consecutive days & cisplatin 60 mg/m² IV infusion on day 8, followed by 14-day rest. Repeat every 5 wk. CRC 1st-line treatment: Administer bid for 14 consecutive days in combination w/ oxaliplatin 130 mg/m² as 2-hr IV infusion on day 1, followed by 7-day rest. Repeat every 3 wk. 2nd-line treatment: Administer bid from day 1-14 in combination w/ irinotecan 125 mg/m² on days 1 & 15, followed by 14-day rest. Repeat every 4 wk. Biliary tract cancer Combination w/ gemcitabine: Initial dose: Adult w/ BSA ≥1.5 m² 50 mg bid, 1.25 to <1.5 m² 40 mg bid, <1.25 m² 40 mg in the morning, 20 mg in the evening. Administer bid for 14 consecutive days & gemcitabine 1,000 mg/m² IV infusion on days 1 & 8, followed by 7-day rest. Repeat every 3 wk. Combination w/ gemcitabine & cisplatin: Administer bid for 7 consecutive days & gemcitabine 1,000 mg/m² & cisplatin 25 mg/m² IV infusion on day 1, followed by 7-day rest. Repeat every 2 wk.

Should be taken with food.

History of hypersensitivity. Severe bone marrow depression. Patients receiving treatment w/ other fluoropyrimidine-group anti-cancer drugs including combination therapies & flucytosine. Severe renal & hepatic disorder. Known or suspected pregnancy.

Discontinue immediately if jaundice occurs; in onset or progression of interstitial pneumonia. Avoid appearance or aggravation of infection or bleeding tendency. HBV reactivation in HBV carriers, HBs antigen -ve & HBc Ab +ve patients, or HBs antigen -ve & HBs Ab +ve patients; follow-up monitoring of hepatic function test or viral markers are recommended. Acute leukemia or myelodysplastic syndrome. Stomatitis, diarrhea, blood dyscrasia & neuropathy in patients w/ deficiency of dihydropyrimidine dehydrogenase. Cerebral infarction. Remarkable decrease in gastric pH. May cause bulbar conjunctival & scleral pigmentation & nebula in repeated administration. Patients w/ bone marrow depression, infectious disease, abnormal glucose tolerance; current or previous history of interstitial pneumonia & heart disease; GI ulcer or hemorrhage; varicella. Closely monitor hepatic functions by periodic hepatic function tests to detect hepatic disorder early. Perform lab tests (hematological tests, liver & renal function tests) before start of each course & at least once every 2 wk during dosing; frequently when 1 course of regimen is conducted & dose is increased. Provide min washout period of 7 days after w/drawal if in combination w/ other fluoropyrimidine-group anti-cancer drug or other antifungal agent flucytosine. Fluid replacement if dehydration secondary to severe enteritis occurs. Examine patients for presence of interstitial pneumonia prior to therapy & monitor properly for resp status & onset of symptoms eg, cough & fever. Monitor chest X-ray exam. Confirm status of previous exposure to hepatitis infection. Avoid concomitant use w/ other fluoropyrimidine-group anti-cancer drugs, combination therapies eg, folinate + tegafur-uracil combination therapy; antifungal agent flucytosine. Combination w/ chest or abdominal radiation. Moderate influence on ability to drive & use machines. Renal & hepatic disorder. Potential gonadic effects in patients w/ reproductive potential. Contraindicated in known or suspected pregnancy. Discontinue in lactation. Low birth wt infants, neonates, infants or childn. Elderly.

Leukopenia, neutropenia, thrombocytopenia, erythrocytopenia, decreased Hb, decreased hematocrit value, lymphopenia; increased AST (GOT), ALT (GPT), bilirubin & Al-P; anorexia, nausea/vomiting, diarrhea, stomatitis, taste abnormality; pigmentation; rash; general malaise; increased LDH, decreased total protein & albumin. TEN, SJS.

Increased blood conc of fluorouracil; phenytoin. Serious blood dyscrasia & GI disorder w/ fluorouracil, tegafur/uracil, tegafur, doxifluridine, capecitabine, folinate/tegafur-uracil, levofolinate/fluorouracil, flucytosine. Enhanced effect of warfarin K. Aggravated adverse reactions w/ other anti-cancer drugs or RT.

Cytotoxic Chemotherapy

L01BC53 - tegafur, combinations ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

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