DBL Fluorouracil

Alone or in combination for palliative treatment of malignant tumours, particularly of breast, colon or rectum. Gastric, primary hepatic, pancreatic, uterine (cervical), ovarian & bladder carcinomas.

IV infusion 15 mg/kg in 300-500 mL of 5% glucose over 4 hr, may be continued daily until 1st GI side effects occur. Discontinue treatment until side effects recede then place on maintenance therapy. IV inj 12 mg/kg daily for 3 consecutive days, followed by 6 mg/kg on 5th, 7th & 9th day, then place on maintenance therapy: 5-10 mg/kg once wkly.

Hypersensitivity. Bone marrow depression following RT or other antineoplastic agents (leucocyte <5,000/mm³ & platelet <100,000/mm³), suffering from potentially serious infection, known complete dihydropyrimidine dehydrogenase (DPD) deficiency, poor nutritional state, debilitated. Not to be taken w/in 4 wk of brivudine, sorivudine or chemically-related analogues. Pregnancy.

Not to be re-administered after documented CV reaction (arrhythmia, angina, ST segment changes). Discontinue use if leucopenia, thrombocytopenia, stomatitis, oesophagopharyngitis, intractable vomiting, diarrhoea, melaena, haemorrhage, oral ulceration, GI ulceration or bleeding, multifocal inflammatory leukoencephalopathy (MILE) occurs. Myelosuppression; unusual stress, cardiotoxicity, history of heart disease; bone marrow depression; palmar-plantar erythrodysesthesia; Wernicke's encephalopathy; tumor lysis syndrome. Monitor platelets & WBC counts daily. Not to be used in patients w/ complete DPD deficiency. Avoid prolonged exposure to sunlight. Interference w/ diagnostic thyroid function tests. High-dose pelvic irradiation, previous treatment w/ alkylating agents. Avoid use w/ live or live-attenuated vaccine. Concomitant use w/ phenytoin, other chemotherapeutic agents, folinic acid. Renal & hepatic impairment; jaundice. May affect fertility. Women of childbearing potential & male partners should use adequate contraception. Not to be used during pregnancy & lactation. Elderly ≥70 yr.

Nausea, vomiting, diarrhoea, stomatitis, proctitis, malaena, GI haemorrhage & ulcer, oesophagitis; hepatocellular injury; dehydration, decreased appetite, tumour lysis syndrome; anaphylactic reaction, hypersensitivity; dermatological reactions; leucopenia, granulocytopenia; chest pain, tachycardia, breathlessness, arrhythmia, ECG changes, angina pectoris, myocardial ischaemia, MI, cardiac shock & failure, myocarditis, cardiomyopathy & stress cardiomyopathy, pericarditis, thrombophlebitis, haemorrhage; ocular toxicity; neurological, neurotoxicity effects; infections & infestations; local inj site reaction, fever.

Increased hematotoxicity w/ myelosuppressive drugs. Increased GI toxicity w/ folinic acid (leucovorin). Decreased bone marrow depression degree w/ allopurinol. Biochemically modulated antitumour efficacy or toxicity w/ MTX. Reduced clearance by metronidazole. MILE w/ levamisole. Increased plasma conc by cimetidine. Increased phenytoin plasma conc w/ concomitant capecitabine. Increased exposure w/ brivudine, sorivudine or chemically-related analogues. Potentiated bone marrow effects w/ RT. Elevated INR & bleeding episodes w/ warfarin. Interfered metabolism of thiamine. Serious fatal infections w/ live or live-attenuated vaccines. Increased total serum thyroxine conc.

Cytotoxic Chemotherapy

L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

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