TS-ONE

Per 20 mg cap Tegafur 20 mg, gimeracil 5.8 mg, oteracil K 19.6 mg. Per 25 mg cap Tegafur 25 mg, gimeracil 7.25 mg, oteracil K 24.5 mg

Adults w/ unresectable advanced gastric cancer in combination w/ cisplatin or as monotherapy for patients intolerant to cisplatin; locally advanced gastric cancer as monotherapy for post-op adjuvant treatment; locally advanced or unresectable or metastatic NSCLC in combination w/ carboplatin; NSCLC as monotherapy in those who have received platinum-based treatment; locally advanced or unresectable or metastatic CRC in combination w/ oxaliplatin as 1st-line treatment or in combination w/ irinotecan as 2nd-line treatment; locally advanced or unresectable or metastatic pancreatic cancer as monotherapy; pancreatic cancer & monotherapy for post-op adjuvant chemotherapy; metastatic HER-2 -ve breast cancer as monotherapy.

Adult ≥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. Combination therapy: NSCLC Administer bid for 14 consecutive days, in combination w/ carboplatin on day 1. Repeat every 3 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. Repeat every 3 wk. 2nd line of treatment: Administer bid from day 1-14, in combination w/ irinotecan 125 mg/m² on days 1 & 15. Repeat every 4 wk. Gastric cancer Administer bid for 21 consecutive days & cisplatin 60 mg/m² IV infusion on day 8, followed by 14 days rest. Repeat every 5 wk.

Should be taken with food: Take after breakfast & evening meals.

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. Acute leukemia. Remarkable decrease in gastric pH. May cause bulbar conjunctival & scleral pigmentation & nebula in repeated administration. HBV reactivation. 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. 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 the presence of interstitial pneumonia prior to therapy & monitor properly for resp status & onset of symptoms eg, cough & fever. Monitor for hepatic function tests or viral markers. Avoid concomitant use w/ other fluoropyrimidine-group anti-cancer drugs, combination therapies eg, folinate + tegafur-uracil combination therapy; antifungal agent flucytosine. May affect ability to drive & use machines. Renal & hepatic disorder. Potential gonadic effects in patients w/ reproductive potential. Contraindicated in pregnancy. Discontinue in lactation. Elderly.

Leukopenia, neutropenia, decreased Hb, thrombocytopenia, increased AST (GOT) & ALT (GPT), anorexia, nausea, vomiting, diarrhea, general malaise, stomatitis, pigmentation, rash; pneumonitis, dyspnea, resp failure. Peripheral neuropathy.

Increased blood conc of fluorouracil. Serious blood dyscrasia & GI disorder w/ fluorouracil, tegafur/uracil, tegafur, doxifluridine, capecitabine, folinate/tegafur-uracil, levofolinate/fluorouracil, flucytosine. Increased blood conc of phenytoin. 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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