#高警訊藥品

乳癌、肺癌、消化器癌 Breast cancer; Colon and rectal cancer; Gastric cancer; Pancreatic cancer

Antimetabolite Antineoplastic Agent (Pyrimidine Analog)
A pyrimidine analog antimetabolite that interferes with DNA and RNA synthesis; after activation, F-UMP (an active metabolite) is incorporated into RNA to replace uracil and inhibit cell growth; the active metabolite F-dUMP, inhibits thymidylate synthetase, depleting thymidine triphosphate (a necessary component of DNA synthesis).

Metabolism: Tissues; Hepatic
Excretion: (Renal) 7 to 20% unchanged
Elimination Half Life: 16 min

1. Bone marrow depression
2. Current or potential pregnancy (advise female patients to use effective contraception during treatment and for at least 1 month after last dose)
3. Dihydropyrimidine dehydrogenase deficiency; Known hypersensitivity to fluorouracil or to any component of the product
4. Poor nutritional state
5. Potentially serious infection

Avoid breastfeeding

Common:
1. Allergic contact dermatitis, Hand-foot syndrome, Pruritus, Sensation of burning of skin, Sore skin, Ulcer or mucosa
2. Gastrointestinal: Diarrhea, Inflammatory disease of mucous membrane
3. Hematologic: Leukocytosis
Serious:
1. Cardiovascular: Angina pectoris, Cardiotoxicity, Nonspecific ST-T abnormality on electrocardiogram
2. Gastrointestinal: Gastrointestinal ulcer
3. Hematologic: Myelosuppression, Anemia, leukopenia, thrombocytopenia
4. Neurologic: Hyperammonemic encephalopathy, Neurotoxicity

Initial dose:
1. General: 12 mg/kg IV daily for 4 days; if tolerated, administer 6 mg/kg IV daily on days 6, 8, 10, 12 (MAX dose 800 mg/day).
2. In patients with poor nutritional state or improved condition: 6 mg/kg/day IV daily for 3 days; if tolerated, administer 3 mg/kg IV daily on days 5, 7, 9 (MAX dose 400 mg/day).
Maintenance dose:
1. Repeat cycle every 30 days after initial dosing
2. Consider single dose 10-15 mg/kg/week if tolerated; do not exceed 1 g/week

Safety and effectiveness have not been established in pediatric patients.

1. CrCl <50 mL/minute and CRRT: No dosage adjustment necessary
2. Hemodialysis: Administer standard dose or 50% of statndard dose following hemodialysis on dialysis days

1. Bilirubin >5 mg/dL: Avoid use
2. Hepatic impairment (degree not specified): Administer <50% of dose, then increase if toxicity does not occur

Dilute with 0.9% NS or D5W; store at room temperature for 72 hours