TS-ONE Warnings

Cancer chemotherapy with TS-ONE, as a single drug or in combination, should be administered only to patients for whom treatment with TS-ONE has been judged appropriate, under the supervision of experienced physicians who are familiar with cancer chemotherapy and who are based in medical institutions with adequate facilities. A patient who will receive chemotherapy that includes TS-ONE should be carefully selected with reference to the package insert of each concomitant drug. TS-ONE should only be administered after the effectiveness and risks have been explained, informed consent has been given by the patient or by the patient's guardian before chemotherapy is started.
Since the dose-limiting toxicity (DLT) of TS-ONE is bone marrow depression (See Adverse Reactions), in which is different from conventional oral fluorouracil-group drugs, it is necessary to pay attention for changes in the laboratory data. Laboratory tests should be conducted frequently.
In as much as there may occur severe hepatic disorders, such as fulminant hepatitis, the patient's hepatic functions should be monitored closely by periodic hepatic function tests to detect hepatic disorder early. Close monitoring should be given to detect possible malaise accompanied by anorexia, in which is thought to be a sign or subjective symptom of hepatic disorder. If jaundice (yellow ocular coloring) appears, TS-ONE should be discontinued immediately, and appropriate measures should be taken.
TS-ONE should not be combined with other fluoropyrimidine-group anti-cancer drugs, combination therapies with them (such as folinate plus Tegafur-Uracil combination therapy), or the antifungal agent flucytosine because there is a possibility that combination with these drugs may cause adverse reactions such as serious blood dyscrasia (See Interactions).
Read this package insert carefully before using TS-ONE. In addition, TS-ONE should be administered in strict conformity with the Dosage and Administration.
Based on the Ministry of Public Health's Announcement: This drug may cause serious harm, should be used under the supervision of a physician.