TS-One

TS-One

tegafur + gimeracil + oteracil

Manufacturer:

Taiho

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Per 20 mg cap Tegafur 20 mg, oteracil K 19.6 mg, gimeracil 5.8 mg. Per 25 mg cap Tegafur 25 mg, oteracil K 24.5 mg, gimeracil 7.25 mg
Indications/Uses
Post-op adjuvant chemotherapy for locally advanced stage II (excluding T1), IIIA or IIIB gastric cancer.
Dosage/Direction for Use
Taken for 28 consecutive days, followed by a 14-day rest. Initial dose can be decreased according to patient's condition. Lower limit: 40 mg. Adult BSA ≥1.5 m2 Initially 60 mg bd, 1.25 to <1.5 m2 Initially 50 mg bd, <1.25 m2 Initially 40 mg bd.
Administration
Should be taken with food: Take after breakfast & evening meals.
Contraindications
Hypersensitivity. Patients receiving other fluoropyrimidine-group anticancer drugs &/or flucytosine. Patients w/ severe bone marrow depression; complete dihydropyrimidine dehydrogenase (DPD) deficiency; severe renal &/or severe hepatic impairment. Pregnancy.
Special Precautions
Provide a min washout period of 7 days when other fluoropyrimidine-group anticancer drugs or flucytosine are used after TS-One w/drawal. Provide an appropriate washout period when TS-One is used after w/drawal of other fluoropyrimidine-group anticancer drugs or flucytosine. Carefully monitor patients w/ bone marrow suppression; diarrhea; dehydration. Prevent or correct at onset dehydration & any associated electrolyte disturbances. Closely monitor renal parameters & hepatic function. Increased risk of fluoropyrimidine-related toxicity in patients w/ DPD deficiency. Testing for DPD deficiency prior to treatment initiation is recommended. Avoid appearance or aggravation of infection or bleeding tendency. Potential gonadic effects. May cause or aggravate interstitial pneumonia. Reactivation of hepatitis B. Reports of acute leukemia or myelodysplastic syndrome; cerebral infarction. Risk of ocular toxicity. Concomitant use w/ oral coumarin-derivative anticoagulant. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption. Patients w/ bone marrow depression; infectious disease; abnormal glucose tolerance; current or previous history of interstitial pneumonia; current or previous history of heart disease; GI ulcer or hemorrhage; renal &/or hepatic impairment. Elderly. Discontinue breastfeeding. Safety in low birth wt infants, neonates, infants or childn has not been established.
Adverse Reactions
Bone marrow depression, hemolytic anemia; disseminated intravascular coagulation; fulminant hepatitis; dehydration; severe enteritis; interstitial pneumonia; MI, angina pectoris, arrhythmia, cardiac failure; severe stomatitis, GI ulcer, hemorrhage & perforation; acute kidney injury, nephrotic syndrome; TEN, SJS; leukoencephalopathy; acute pancreatitis; rhabdomyolysis; anosmia; lacrimal duct obstruction. Tegafur: Hepatic cirrhosis.
Drug Interactions
Increased risk of blood dyscrasia & GI disorder (eg, diarrhea & stomatitis) w/ fluoropyrimidine-group anticancer drugs (eg, 5-FU, tegafur/uracil, tegafur, doxifluridine, capecitabine, carmofur); folinate + tegafur/uracil combination therapy, levofolinate/5-FU combination therapy; fluoropyrimidine-group antifungal agent (eg, flucytosine). Increased blood conc of phenytoin. May enhance effect of warfarin K. Aggravated adverse reactions w/ other anticancer drugs or RT.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC53 - tegafur, combinations ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
TS-One cap 20 mg
Packing/Price
56's
Form
TS-One cap 25 mg
Packing/Price
56's
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