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Fluorouracil

Intravenous
Topical
Class
Antimetabolites
Subclass
Thymidylate synthase inhibitors
Substance name
Fluorouracil, 5-fluorouracil, 5-FU
Brand names
Efudex®, Carac®, Fluoroplex®, Tolak®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of breast cancer in females
•
500-600 mg/m² IV q7 days on days 1 and 8 every 28 days for 6 cycles
Other off-label uses
•
Treatment of esophageal cancer (locally advanced, metastatic, esophageal junction, GEJ)
•
Treatment of head and neck cancer
Indications for use
Labeled indications
Adults
•
Treatment of breast cancer in females
•
Treatment of colon cancer
•
Treatment of gastric adenocarcinoma
•
Treatment of pancreatic adenocarcinoma
Off-label indications
Adults
•
Treatment of esophageal cancer (locally advanced, metastatic, esophageal junction, GEJ)
•
Treatment of head and neck cancer
Safety risks
Contraindications
Hypersensitivity to fluorouracil or any product components
Malnutrition
With dihydropyrimidine dehydrogenase enzyme deficiency.
Warnings and precautions
Altered mental status, encephalopathy, confusion, disorientation, ataxia
•
Use caution in all patients.
Cerebellar syndrome, visual impairment
•
Use caution in all patients especially those with acute cerebellar syndrome and other neurologic events.
Diarrhea
•
Maintain a high level of suspicion, as fluorouracil can cause severe diarrhea.
Exacerbation of CVD
•
Use caution in patients with angina, myocardial infarction/ischemia, arrhythmia, and HF.
Exacerbation of skin ulceration
•
Use extreme caution in patients with application of topical fluorouracil on skin abrasion, skin ulceration, or an area of inflammation.
Hematologic disorder
•
Use extreme caution in patients who have had previous myelosuppressive therapy such as chemotherapy or pelvic radiation therapy.
Palmar-plantar erythrodysesthesia
•
Maintain a high level of suspicion in all patients, especially in patients with previous exposure to chemotherapy.
Reactivation of viral infections
•
Use caution in patients with a history of varicella-zoster, other herpes infection (e.g., herpes simplex), or other viral infection.
Specific populations
Renal impairment
eGFR ≥ 60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Use ideal body weight in patients showing obesity, ascites, and oedema.
eGFR 10-60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Use ideal body weight in patients showing obesity, ascites, and oedema.
eGFR < 10 mL/min/1.73 m²
•
Use with caution. Use ideal body weight in patients showing obesity, ascites, and oedema.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required.
Intermittent hemodialysis
•
Use acceptable. No dose adjustment required.
Peritoneal dialysis
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
No guidance available. Monitor serum aminotransferases. Monitor for toxicity.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. There are no adequate and well-controlled studies with fluorouracil in pregnant women. Based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
↓ WBC count, diarrhea, stomatitis
Common 1-10%
•
Alopecia, esophagitis, hyperlacrimation, oral ulcers, palmar-plantar erythrodysesthesia, pharyngitis, abdominal pain, eye pain, fatigue, headache, itchy eyes, loss of appetite, nausea, vomiting, sinusitis
Uncommon < 1%
•
Allergic reactions, hyperpigmentation, photosensitivity of skin, fever
Unknown frequency
•
Agranulocytosis, anemia, cerebellar syndrome, conjunctivitis, ↓ platelet count, gastrointestinal bleeding, ↑ WBC count, ↑ blood eosinophil count, myocardial infarction, nail discoloration, nystagmus, pulmonary embolism, pancytopenia, peptic ulcer disease, phlebitis, chest pain, confusion, dysgeusia, euphoria, injection site reactions, insomnia, irritability, itching, nosebleed, palpitations, photophobia, skin rash, ST-segment changes, skin erythema, teratogenesis, thromboembolism, urticaria, VT
Interactions
Drug(s)
Check Interactions
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