Dangerous Drug: Fluorouracil (5-Fluorouracil, 5-FU)(flure oh yoor’ a sill)
Adrucil, Carac, Efudex, Fluoroplex
PREGNANCY CATEGORY D
Drug Classes
Antimetabolite
Antineoplastic
Therapeutic Actions
Inhibits thymidylate synthetase, leading to inhibition of DNA synthesis and cell death.
Indications
Parenteral: Palliative management of carcinomas of the colon, rectum, breast, stomach, pancreas in select patients considered incurable by surgery or other means
Topical treatment of multiple actinic or solar keratoses
Topical treatment of superficial basal cell carcinoma
Orphan drug uses: In combination with interferon alfa 2-a recombinant for esophageal and advanced colorectal carcinoma; with leucovorin for colon or rectum metastatic adenocarcinoma
Unlabeled use: Topical treatment of condylomata acuminata
Contraindications and Cautions
Contraindicated with allergy to 5-FU; poor nutritional status; serious infections; lactation.
Use cautiously with hematopoietic depression secondary to radiation or chemotherapy; impaired liver function; pregnancy.
Available Forms
Injection—50 mg/mL; cream—0.5%, 1%, 5%; topical solution—2%, 5%
Dosages
Adults
IV
Initial dosage, 12 mg/kg IV daily for 4 successive days; do not exceed 800 mg/day. If no toxicity occurs, give 6 mg/kg on the days 6, 8, 10, and 12, with no drug therapy on days 5, 7, 9, and 11. Discontinue therapy at end of day 12, even if no toxicity.
For patients without toxicity: Repeat dosage every 30 days after the last day of the previous treatment.
For patients with toxicity: Give 10–15 mg/kg/wk as a single dose after signs of toxicity subside. Do not exceed 1 g/wk. Adjust dosage based on patient response; therapy may be prolonged (12–60 mo).
Poor-risk or undernourished patients
6 mg/kg/day IV for 3 days. If no toxicity develops, give 3 mg/kg on the days 5, 7, and 9. No drug is given on days 4, 6, and 8. Do not exceed 400 mg/day.
Adults
Topical
Actinic or solar keratoses: Apply bid to cover lesions. Usually, 0.5% and 1% preparations are used on head, neck, and chest while 2% and 5% preparations are used on hands. Continue until inflammatory response reaches erosion, necrosis, and ulceration stage, then discontinue. Usual course of therapy is 2–4 wk. Complete healing may not be evident for 1–2 mo after cessation of therapy.
Superficial basal cell carcinoma: Apply 5% strength bid in an amount sufficient to cover the lesions. Continue treatment for at least 3–6 wk. Treatment may be required for 10–12 wk.
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