Indications and dose
For fluorouracil
Solid tumours [including gastro-intestinal tract cancers and breast cancer] (specialist use only), Colorectal cancer (specialist use only) for fluorouracil
By intravenous injection, or by intravenous infusion, or by intra-arterial infusion
- Adult
- Specialist indication – access specialist resources for dosing information.
Superficial malignant and pre-malignant skin lesions for fluorouracil
To the skin using cream
- Adult
- Apply 1–2 times a day for 3–4 weeks (usual duration of initial therapy), apply thinly to the affected area, maximum area of skin 500cm2 (e.g. 23cm × 23cm) treated at one time, alternative regimens may be used in some settings.
Important safety information
Important safety information For fluorouracil
MHRA/CHM advice: 5-Fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity (October 2020)
With intravenous use:
Patients with partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with fluoropyrimidines. Healthcare professionals are advised to test all patients for DPD deficiency before initiating treatment and confirm their, including family, history of complete or partial DPD deficiency. Fluorouracil is contra-indicated in patients with known complete DPD deficiency; in those with partial DPD deficiency, a reduced starting dose is recommended. Patients should be monitored for toxicity, particularly during the first cycle of treatment or after a dose increase; severe toxicity can occur even in those with negative test results for DPD deficiency. Therapeutic drug monitoring may improve clinical outcomes in patients receiving continuous fluorouracil infusions. Healthcare professionals should also counsel patients on the benefits and risks of their treatment and ensure they are provided with the patient information leaflet.
Contra-indications
Contra-indications For fluorouracil
With intra-arterial use
Bone marrow depression (after treatment with radiotherapy or other antineoplastic agents); complete or near complete absence of dihydropyrimidine dehydrogenase activity (increased risk of severe, life-threatening, or fatal toxicity)—consult product literature; serious infections
With intravenous use
Bone marrow depression (after treatment with radiotherapy or other antineoplastic agents); complete or near complete absence of dihydropyrimidine dehydrogenase activity (increased risk of severe, life-threatening, or fatal toxicity)—consult product literature; serious infections
Cautions
Cautions For fluorouracil
With intra-arterial use
History of heart disease; partial dihydropyrimidine dehydrogenase deficiency—consult product literature
With intravenous use
History of heart disease; partial dihydropyrimidine dehydrogenase deficiency—consult product literature
With topical use
Avoid contact with eyes and mucous membranes; dihydropyrimidine dehydrogenase deficiency; do not apply to bleeding lesions
Interactions
View interactions for fluorouracil
Side-effects
Side-effects For fluorouracil
General side-effects:
Common or very common
Alopecia; diarrhoea; mucositis; nausea; neutropenia; skin reactions; stomatitis; thrombocytopenia; vomiting
Uncommon
Dizziness; headache
Rare or very rare
Fever
Specific side-effects:
Common or very common
With parenteral use
Agranulocytosis; anaemia; anal inflammation; appetite decreased; asthenia; bone marrow disorders; bronchospasm; gastrointestinal disorders; haemorrhage; hand and foot syndrome (long term use); healing impaired; immunosuppression; increased risk of infection; ischaemic heart disease; leucopenia; malaise
Uncommon
With parenteral use
Arrhythmias; cardiac inflammation; cardiogenic shock; cardiomyopathy congestive; dehydration; drowsiness; euphoric mood; eye disorders; eye inflammation; heart failure; hepatic disorders; hypotension; movement disorders; myocardial infarction; nail discolouration; nail disorders; nerve disorders; ovulation disorder; parkinsonism; photosensitivity reaction; sepsis; spermatogenesis disorder; vision disorders
Rare or very rare
With parenteral use
Biliary sclerosis; cardiac arrest; cerebral ischaemia; cholecystitis; coma; confusion; embolism and thrombosis; encephalopathy; muscle weakness; peripheral vascular disease; renal failure; seizure; speech impairment; sudden cardiac death
With topical use
Abdominal pain; chills; diarrhoea haemorrhagic; leucocytosis; pancytopenia; skin irritation (use a topical corticosteroid for severe discomfort associated with inflammatory reactions); skin ulcer
Frequency not known
With parenteral use
Vein discolouration
With topical use
Conjunctival irritation; excessive tearing; keratitis; taste altered
Conception and contraception
Conception and contraception For fluorouracil
Contraceptive advice required, see Pregnancy and reproductive function in Cytotoxic drugs.
Pregnancy
Pregnancy For fluorouracil
With systemic use:
Avoid (teratogenic). See also Pregnancy and reproductive function in Cytotoxic drugs.
With topical use:
Manufacturers advise avoid (teratogenic).
Breast feeding
Breast feeding For fluorouracil
With intra-arterial use or intravenous use:
Discontinue breast-feeding.
With topical use:
Manufacturers advise avoid.
Hepatic impairment
Hepatic impairment For fluorouracil
With intra-arterial use or intravenous use:
Manufacturer advises caution (increased risk of hyperammonaemia and hyperammonaemic encephalopathy).
Dose adjustments
With intra-arterial use or intravenous use:
Manufacturer advises consider dose reduction.
Renal impairment
Renal impairment For fluorouracil
With intra-arterial use or intravenous use:
Manufacturer advises caution (increased risk of hyperammonaemia and hyperammonaemic encephalopathy).
Dose adjustments
With intra-arterial use or intravenous use:
Manufacturer advises consider dose reduction.
Monitoring requirements
Monitoring requirements For fluorouracil
Monitoring of patient parameters For fluorouracil
With intra-arterial use or intravenous use
Manufacturer advises monitor cardiac function regularly
Handling and storage
Handling and storage For fluorouracil
Caution in handling—irritant to tissues.
Medicinal forms
There can be variation in the licensing of different medicines containing the same drug.
Forms available from special-order manufacturers include: solution for injection.
View all medicinal forms and pricinginformation
Or jump straight to:
- Solution for injection
- Solution for infusion
- Cutaneous cream
- Cytotoxic drugs
- Photodamage
Other drugs in class
Other drugs in classAntimetabolites
- Azacitidine [Specialist drug]
- Azathioprine
- Capecitabine [Specialist drug]
- Cladribine
- Clofarabine [Specialist drug]
- Cytarabine [Specialist drug]
- Daunorubicin with cytarabine [Specialist drug]
- Decitabine [Specialist drug]
- Decitabine with cedazuridine [Specialist drug]
- Fludarabine phosphate [Specialist drug]
- Fluorouracil with salicylic acid
- Gemcitabine [Specialist drug]
- Mercaptopurine
- Methotrexate
- Nelarabine [Specialist drug]
- Pemetrexed [Specialist drug]
- Tegafur with gimeracil and oteracil [Specialist drug]
- Tioguanine [Specialist drug]
- Trifluridine with tipiracil [Specialist drug]
