General Precautions: Because there may occur severe adverse reactions such as bone marrow depression, patients' hematological, hepatic, and renal function should be monitored closely by frequent laboratory examinations. If abnormalities appear, proper treatments should be taken such as dose reduction or discontinuation. Long-term administration should be conducted with great caution because of the potentiality of severe and delayed adverse reactions.
Because there may occur severe liver dysfunction, such as fulminant hepatitis, patients' hepatic function should be monitored closely by regular laboratory examinations, especially in the early stage of administration to detect the liver damage as early as possible. Close monitoring should be given to detect possible fatigue accompanied by anorexia, which is thought to be a signal or subjective symptom of liver dysfunction. If jaundice (yellow ocular coloring) appears, discontinue administration immediately.
There may occur dehydration and severe enteritis (hemorrhagic enteritis, ischemic enteritis, necrotic enteritis, etc.). Accordingly, close observation is necessary. If severe symptoms appear such as severe abdominal pain or diarrhea, discontinue administration and take proper treatments. In case of dehydration, proper fluid supplementation should be taken.
Care should be taken to avoid the manifestation or progression of infections or bleeding tendencies.
The concomitant use of the antiviral drug sorivudine and the fluorouracil-group drug (tegafur, doxifluridine, 5-FU, etc.) may cause severe hematological disease by the inhibition of the metabolism of fluorouracil-group drug. The result may be serious blood dyscrasia. Accordingly, be sure that the patient is not given sorivudine when any fluorouracil-group drug is used.
Administration to children should be conducted with great caution, paying attention to manifestations of adverse reactions.
Administration to children and reproducible patients should be performed with consideration of potential gonadic effects.
Folinate plus Tegafur-Uracil combination therapy: This combination therapy may cause serious diarrhea or enteritis, sometimes leading to fatal outcome. Patients should be closely observed and if symptoms of severe abdominal pain or diarrhea develop, discontinue the chemotherapy and take proper measures. Dehydration should be managed with fluid replacement or other appropriate treatments.
This combination therapy may cause fulminant hepatitis or serious bone marrow depression, sometimes leading to fatal outcome. The patients' conditions should be closely observed by regular monitoring of hepatic and hematologic parameters (at least once a course, plus additional tests prior to first and second courses). If any abnormalities are detected, take appropriate measures, eg, dose reduction or withdrawal.
Pediatric use: The safety of this product in children has not been established.
Use in the elderly: Care should be exercised in administration to elderly patients whose physiological functions are generally in a diminished state.
Others: It is reported that changes have been observed in cerebral tissues, such as in the columna fornicis and the commissura anterior, during long-term (nine-months) administration of high dose to dogs.