Loading…
FLUOROURACIL is a brand name for Fluorouracil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fluorouracil is indicated in adults. Fluorouracil is indicated in the treatment of the following malignancies and disease settings: - in the treatment of metastatic colorectal cancer - as adjuvant treatment in colon and rectal cancer - in the treatment of advanced gastric cancer, - in the treatment of advanced…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 5-fluorouracil should be administered only under the supervision of a qualified physician with extensive experience in cytotoxic treatment. Patients must be carefully and frequently monitored during the treatment. The risks and benefits to individual patients should be carefully considered before each treatment.
Method of administration 5-fluorouracil can be administered by intravenous injection as bolus, infusion or continuous infusion for up to several days. These are general advices. Please refer to a local or international guideline for a more (up to date) recommendation.
6 Intravenous administration: The dose of 5-fluorouracil and the treatment schedule depends on the chosen treatment regimen, the indication, the general status and previous treatment of the patient. Treatment regimens vary in the combination of 5-fluorouracil with other cytotoxic agents or dose of concomitantly used folinic acid.
The number of cycles used should be decided by the treating clinician depending on local treatment protocols and guidelines; taking into consideration treatment success and tolerability in individual patients. Initial treatment should be given in hospital.
Reduction of the dose is advisable in patients with any of the following: 1. Cachexia 2. Major surgery within preceding 30 days 3. Reduced bone marrow function 4. Impaired hepatic or renal function Adults and elderly patients receiving 5-fluorouracil should be monitored prior to each dose for haematological (platelet, leucocyte, and granulocyte counts), gastrointestinal (stomatitis, diarrhoea, bleeding from the gastrointestinal tract), and neurological toxicity, and, if necessary, the dose of 5-fluorouracil may be either reduced or withheld.
Necessity of dosage adjustment or discontinuation of the medicinal product depends on the occurrence of undesirable effects. Haematological toxicities such as reduced leukocytes (≤ 3500/mm3) and/or platelet counts (≤ 100000/mm3) can require treatment interruption.
Resumption of treatment must be decided by the treating clinician depending upon the clinical scenario. Colorectal cancer: 5-fluorouracil is used in the treatment of colon and rectal cancers in a number of treatment regimens. 5-fluorouracil is preferably used along with folinic acid.
Commonly used treatment regimens also combine 5-fluorouracil and folinic acid with other chemotherapeutic agents such as Irinotecan (FOLFIRI and FLIRI), Oxaliplatin (FOLFOX) or both Irinotecan and Oxaliplatin (FOLFIRINOX). The commonly used dose range of 5-fluorouracil varies from 200-600mg/m2 of body surface.
The following undesirable effects have been observed and reported during treatment with Fluorouracil Injection with the following frequencies: Very common (≥1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10000 to < 1/1000), Very rare (< 1/10000), Not known (frequency cannot be estimated from the available data).
Blood and lymphatic system disorders:
Very common Myelosuppression, Neutropenia, Thrombocytopenia, Leukopenia, Agranulocytosis, Anaemia, Pancytopenia Common Febrile neutropenia Not known Granulocytopenia Immune system disorders Very common Bronchospasm, Immunosuppression Rare Hypersensitivity Anaphylactic reaction Anaphylactic shock Infections and infestations Very common Infections, Pharyngitis Common Sepsis Not known Septic shock, Neutropenic sepsis, Pneumonia, Urinary tract infection, Cellulitis Investigations Common Electrocardiogram change Endocrine disorders: Rare Thyroxine increased Tri-iodothyronine increased Metabolism and nutrition disorders Very common Hyperuricemia Uncommon Dehydration Not known Decreased appetite, Lactic acidosis, Tumour lysis syndrome, Hypertriglyceridaemia, Vitamin B1 deficiency Psychiatric disorders Uncommon Euphoric mood Rare Confusional state Very rare Disorientation Nervous system disorders Uncommon Nystagmus Headache Dizziness Symptoms of Parkinson's disease Pyramidal signs Somnolence Very rare leukoencephalopathy Cerebellar syndrome Dysarthria Myasthenia Aphasia Convulsion Coma Not known Peripheral neuropathy, Epilepsy, Hyperammonaemic encephalopathy, Posterior reversible encephalopathy syndrome (PRES), Wernicke’s encephalopathy Renal and urinary disorders Rare Renal failure Eye disorders Uncommon Lacrimation increased Blurred vision, Eye movement disturbance, Optic neuritis, Diplopia, Decrease in visual acuity, Photophobia, Conjunctivitis, Blepharitis, Ectropion, Dacryostenosis, Cardiac disorders Very common ECG signs of myocardial ischaemia Common Myocardial infarction, Angina pectoris Uncommon Arrhythmia, Myocardial ischaemia, Myocarditis, Cardiac failure, Congestive cardiomyopathy, Cardiac shock Very rare Cardiac arrest, Sudden cardiac death Not known Intracardiac thrombus Pericarditis Stress cardiomyopathy (takotsubo syndrome) Vascular disorders Uncommon Hypotension Rare Cerebral ischaemia, Intestinal ischaemia, Peripheral ischaemia, Raynaud's syndrome, Thromboembolism, Thrombophlebitis, Not known Haemorrhage Gastrointestinal disorders Very common Mucosal inflammation, stomatitis, Oesophagitis, Proctitis) Anorexia, Diarrhoea, Nausea, Vomiting Uncommon Gastrointestinal ulcer Gastrointestinal haemorrhage Gastrointestinal mucosal exfoliation Not known Melaena, Pneumatosis intestinalis, Enterocolitis, Colitis (including necrotising colitis) Hepatobiliary disorders Uncommon Hepatocellular injury Very rare Hepatic necrosis, Biliary sclerosis, Cholecystitis Skin and subcutaneous tissue disorders Very common Alopecia Palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome) Uncommon Dermatitis Dry skin Fissure erosion Erythema Pruritic maculopapular rash Exanthema Urticaria Photosensitivity Hyperpigmentation of the skin Hyperpigmentation or depigmentation near the veins Nail pigmentation Nail dystrophy Nail bed disorder Paronychia Onycholysis Not known Cutaneous lupus erythematosus Reproductive system disorders Uncommon Azoospermia Ovulation disorder General disorders and administration site conditions Very Common Delayed wound healing Epistaxis Malaise Asthenia Fatigue Not known Pyrexia, Chest pain, Injection site discolouration, Local reaction caused by extravasation (pain, swelling, erythema) c.
It is recommended that fluorouracil be given only by, or under the strict supervision of, a qualified physician who is conversant with the use of potent antimetabolites and has the facilities for regular monitoring of clinical, biochemical and haematological effects during and after administration.
All patients should be admitted to hospital for initial treatment. Haematological effects Fluorouracil, may produce myelosuppression (including, but not limited to, leukopenia, granulocytopenia, pancytopenia and thrombocytopenia). ) count commonly being observed between the 7th and 14th day of the first course, but occasionally being delayed for as long as 20 days.
The count usually returns to normal by the 30th day. C. C. count falls below 3,500 per mm3. If the total count is less than 2000 per mm3, and especially if there is granulocytopenia, it is recommended that the patient be placed in protective isolation in the hospital and treated with appropriate measures to prevent systemic infection.
Clinical consequences of severe myelosuppresion include infections. These infections may be mild, but can be severe and at times fatal. I. tract or haemorrhage at any site. The ratio between effective and toxic dose is small and therapeutic response is unlikely without some degree of toxicity.
Care must be taken therefore, in the selection of patients and adjustment of dosage. Treatment should be stopped in case of severe toxicity. Special risk patients Fluorouracil should be used with extreme caution in patients who have previously received high-dose pelvic irradiation or alkylating agents, and in those who have a widespread involvement of bone marrow by metastatic tumors.
Fluorouracil treatment may potentiate necrosis caused by radiation. 5). Particular care should be taken in the treatment of elderly or debilitated patients, as these patients may be at increased risk of severe toxicity. Renal and hepatic impairment Fluorouracil should be used with caution in patients with reduced renal or liver function or jaundice.
g. Herpes zoster, chickenpox). • Are seriously debilitated . • Are suffering from bone marrow depression after radiotherapy or treatment with other antineoplastic agents. 5). Fluorouracil must not be taken within 4 weeks of treatment with brivudine, sorivudine or their chemically related analogues.
• Fluorouracil (5-FU) must not be given to patients homozygotic for dihydropyrimidine dehydrogenase (DPD). 6). 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fluorouracil in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The dose also varies depending administration as intravenous bolus or as continuous intravenous infusion. The dose schedules also vary depending on the chemotherapy regimen, and 5- fluorouracil dose could be repeated weekly, bimonthly or monthly.
The number of cycles varies with the treatment regimens used and also depends on the clinical decision based on treatment success and tolerability. Breast cancer: 5-fluorouracil is commonly used in chemotherapy regimens in combination with cyclophosphamide and methotrexate (CMF), or epirubicin, cyclophosphamide (FEC) or methotrexate and leucovorin (MFL).
The usual dose range is 500- 600 mg/m2 body surface as an intravenous bolus and repeated every 3–4 weeks as necessary. In adjuvant treatment of primary invasive breast cancer, duration of treatment will usually continue for 6 cycles.
Gastric cancer and cancer of gastroesophageal junction:
Peri-operative chemotherapy with ECF regimen (epirubicin, cisplatin, 5-fluorouracil) is currently recommended. The recommended dose of 5-fluorouracil is 200 mg/m2 body surface per day given as continuous intravenous infusion for 3 weeks.
6 cycles are recommended but this depends on treatment success and tolerability of medicinal product by the patient. Oesophageal cancer: 5-fluorouracil is commonly used in combination with cisplatin; or cisplatin and epirubicin; or epirubicin and oxaliplatin.
Dose varies between 200- 1000 mg/m2 body surface per day as continuous intravenous infusion over several days and repeated cyclically depending upon regimen. For cancers involving lower part of oesophagus, peri-operative chemotherapy with ECF regimen (epirubicin, cisplatin, 5-fluorouracil) is commonly recommended.
The recommended dose of 5-fluorouracil is 200 mg/m2 body surface per day given as continuous intravenous infusion for 3 weeks and repeated cyclically. Concerning administration of 5-fluorouracil/cisplatin in combination with radiotherapy, please refer to the literature.
Pancreatic cancer: 5-fluorouracil is preferably used in combination with folinic acid or gemcitabine. Dose varies between 200- 500 mg/m2 body surface per day as intravenous bolus injection or intravenous infusion, depending on the regimen and repeated cyclically.
Head and neck cancer: 5-fluorouracil is preferably used in combination with cisplatin or carboplatin. Dose varies between 600- 1200 mg/m2 body surface per day as continuous intravenous infusion over several days and repeated cyclically depending upon regimen.
Concerning administration of 5-fluorouracil/ cisplatin or carboplatin in combination with radiotherapy, please refer to the literature. Special populations Renal or hepatic impairment Caution is advised and the dose might need to be reduced in patients with renal or hepatic impairment.
Paediatric population Fluorouracil is not recommended for use in children due to insufficient data on safety and efficacy. Elderly No dose adjustments in elderly are recommended but care should be taken to consider any concomitant condition in determining the dose.
Description of selected adverse reactions Myelosuppression Observed onset of myelosuppression varied between 7-10 days, nadir between 9-14 days, and recovery occurred between 21-28 days. Cardiac disorders Cardiotoxic adverse events mostly occur during or within hours following the first treatment cycle.
4). Hepatobiliary disorders Fatal cases of hepatic necrosis have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Cardiotoxicity Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, arrhythmias, myocarditis, cardiogenic shock, sudden death, stress cardiomyopathy (takotsubo syndrome) and electrocardiographic changes (including very rare cases of QT prolongation).
These adverse events are more common in patients receiving continuous infusion of 5-fluorouracil rather than bolus injection. Prior history of coronary artery disease may be a risk factor for some cardiac adverse reactions. Care should therefore be exercised in treating patients who experienced chest pain during courses of treatment, or patients with a history of heart disease.
Cardiac function should be regularly monitored during treatment with fluorouracil. In case of severe cardiotoxicity the treatment should be discontinued. Immunosuppressant effects Vaccination with a live vaccine should be avoided in patients receiving 5-fluorouracil due to the potential for serious or fatal infections.
Contact should be avoided with people who have recently been treated with polio virus vaccine. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished. Hand-foot syndrome The administration of fluorouracil has been associated with the occurrence of palmar- plantar erythrodysesthesia syndrome, also known as hand-foot syndrome.
Continuous- infusion fluorouracil may increase the incidence and severity of palmar-plantar erythrodysesthesia. Interruption of therapy is followed by gradual resolution over 5 to 7 days. Encephalopathy Cases of encephalopathies (including hyperammonaemic encephalopathy, leukoencephalopathy, posterior reversible encephalopathy syndrome [PRES], Wernicke’s encephalopathy), associated with 5-fluorouracil treatment have been reported from post-marketing sources.
Signs or symptoms of encephalopathy are altered mental status, confusion, disorientation, coma or ataxia. If a patient develops any of these symptoms withhold treatment and test serum ammonia and vitamin B1 levels immediately. In case of elevated serum ammonia levels or vitamin B1 deficiency initiate appropriate therapy.
Hyperammonaemic encephalopathy often occurs together with lactic acidosis. Caution is necessary when administering fluorouracil to patients with renal and/or hepatic impairment. Patients with impaired renal and/or hepatic function may have an increased risk for hyperammonaemia and hyperammonaemic encephalopathy.
Tumour Lysis Syndrome Cases of tumour lysis syndrome associated with fluorouracil treatment have been reported from post-marketing sources. g. with renal impairment, hyperuricemia, high tumour burden, rapid progression) should be closely monitored.
g. hydration, correction of high uric acid levels) should be considered. 2). Patients with DPD deficiency are therefore at increased risk of fluoropyrimidines- related toxicity, including for example stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity.
DPD-deficiency related toxicity usually occurs during the first cycle of treatment or after dose increase. […]