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FLUOROURACIL is a brand name for Fluorouracil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fluorouracil may be used alone or in combination, for its palliative action in the management of common malignancies particularly cancer of the colon and breast.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults:
Selection of an appropriate dose and treatment regime depends upon the condition of the patient, the type of carcinoma being treated and whether fluorouracil is to be administered alone or in combination with other therapy. 8 - 1 gram.
It is customary to calculate the dose in accordance with the patient's actual bodyweight unless there is obesity, oedema or some form of abnormal fluid retention such as ascites. Ideal weight is used as the basis for calculation in such cases.
Fluorouracil injection should not be mixed directly, in the same container, with other chemotherapeutic agents or intravenous additives. Fluorouracil is often administered concomitantly with leucovorin which may potentiate the therapeutic effects of fluorouracil.
Therefore, the toxicity of fluorouracil, especially GI and hematologic, may be increased. 5).
The following regimens have been recommended for use as a single agent:
Initial Treatment: This may be in the form of an infusion or an injection, the former usually being preferred because of lesser toxicity. 9% NaCl injection and given over 4 hours. Alternatively the daily dose may be infused over 30 - 60 minutes or may be given as a continuous infusion over 24 hours.
The infusion may be repeated daily until there is evidence of toxicity or a total dose of 12 - 15g has been reached. Intravenous Injection: 12mg/kg bodyweight, but not more than the recommended 1g daily dose may be given daily for 3 days and then, if there is no evidence of toxicity, 6mg/kg on alternate days for 3 further doses.
An alternative regimen is 15mg/kg as a single intravenous injection once a week throughout the course. 5mg/kg bodyweight daily may be given by 24 hour continuous intra-arterial infusion.
Maintenance therapy:
An initial intensive course may be followed by maintenance therapy providing there are no significant toxic effects. In all instances, toxic side effects must disappear before maintenance therapy is started. If, however, they do appear, therapy must be discontinued until the symptoms resolve.
The initial course of fluorouracil can be repeated after an interval of 4 to 6 weeks from the last dose or, alternatively, treatment can be continued with intravenous injections of 5-15mg/kg bodyweight at weekly intervals. This sequence constitutes a course of therapy.
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 ( 1/1,000 to < 1/100), Rare ( 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Frequency not known (cannot be estimated from the available data).
Infections and infestations:
Very common Infections Blood and lymphatic system disorders: Very common Myelosuppression (leucopenia, pancytopenia and thrombocytopenia); agranulocytosis, anaemia Common Febrile neutropenia Immune system disorders: Very common Bronchospasm, Immunosuppression with an increased risk of infection.
Rare Hypersensitivity reactions, generalised anaphylactic and allergic reactions.
Metabolism and nutrition disorders:
Frequency not known Lactic acidosis, tumour lysis syndrome, hypertriglyceridaemia, vitamin B1 deficiency Psychiatric disorders: Uncommon Euphoria Rare a reversible confusional state may occur Very rare Disorientation Nervous system disorders Uncommon Nystagmus, headache, dizziness, symptoms of Parkinson's disease, pyramidal signs, and somnolence Very rare Cases of leukoencephalopathy have also been reported.
With symptoms including ataxia, acute cerebellar syndrome, dysarthria, myasthenia, aphasia, convulsion or coma in patients receiving high doses of 5-fluorouracil and in patients with dihydropyrimidine dehydrogenase deficiency, kidney failure Frequency not known Peripheral neuropathy may occur, Hyperammonaemic encephalopathy, Posterior reversible encephalopathy syndrome (PRES), Wernicke’s encephalopathy Eye disorders: Uncommon Incidences of excessive lacrimation, dacryostenosis, visual changes and photophobia.
Cardiac disorders Very common ECG changes Common Angina pectoris-like chest pain Uncommon Arrhythmia, myocardial infarction, myocardial ishchaemia, dilative cardiomyopathy Very rare Cardiac arrest and sudden cardiac death Frequency not known Stress cardiomyopathy (takotsubo syndrome), pericarditis, tachycardia, breathlessness, cardiac shock, cardiac failure, myocarditis Special attention is therefore advisable in treating patients with a history of heart disease or those who develop chest pain during treatment.
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. All patients should be admitted to hospital for initial treatment.
The most pronounced and dose-limiting toxic effects of fluorouracil are on the normal, rapidly proliferating cells of the bone marrow and the lining of the gastrointestinal tract. The immunosuppressive effect of fluorouracil may cause a higher incidence of microbial infections, delayed wound healing and bleeding of the gums.
) 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.
Gastrointestinal effects Treatment should be stopped at the first sign of oral ulceration or if there is evidence of gastrointestinal side effects such as stomatitis, diarrhoea or bleeding from the gastrointestinal tract or haemorrhage at any site, oesophagopharyngitis or intractable vomiting.
Fluorouracil should be resumed only when the patient has recovered from the above signs. 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.
Radiotherapy Fluorouracil treatment may potentiate necrosis caused by radiation. 5). ) or prior use of another chemotherapeutic agent causing myelosuppression, have a widespread involvement of bone marrow by metastatic tumours, or those with reduced renal or liver function, jaundice or who have a poor nutritional state.
5). Fluorouracil must not be taken within 4 weeks of treatment with brivudine, sorivudine or their chemically related analogues. Fluorouracil should not be used in the management of non-malignant disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Some patients have received up to 30g at a maximum rate of 1 g daily. A more recent alternative method is to give 15mg/kg IV once a week throughout the course of treatment. This obviates the need for an initial period of daily administration.
In combination with irradiation Irradiation combined with fluorouracil has been found to be useful in the treatment of certain types of metastatic lesions in the lungs and for the relief of pain caused by recurrent, inoperable growth.
The standard dose of fluorouracil should be used. Dose reduction in certain situations The initial dose should be reduced by one-third to one half in patients with any of the following: 1. Cachexia. 2. Major surgery within preceding 30 days.
3. Reduced bone marrow function. 5 x 109/l and/or the thrombocyte count is < 75 x 109/l, the treatment should be discontinued for one week. If the blood count is normalised during this period of time, the treatment can be resumed. 5 < 75 Suspend treatment.
4. Impaired hepatic or renal function. If plasma bilirubin concentration is >5 mg/dl, treatment with fluorouracil should be discontinued. 2).
Children:
No recommendations are made regarding the use of fluorouracil in children.
Elderly:
Fluorouracil should be used in the elderly with similar considerations as in younger adults, notwithstanding that incidence of concomitant medical illness is higher in the former group. Fluorouracil should be used with caution in elderly patients.
The female gender and an age of 70 years or older are reported as independent risk factors for severe toxicity from fluorouracil-based chemotherapy. Close monitoring for multiple organ toxicities and vigorous supportive care of those with toxicity are necessary.
Elderly patients more frequently manifest a decreased kidney function correlated to age, which makes a decrease in dosage necessary for those patients undergoing fluorouracil treatment.
Vascular disorders:
Rare Cerebral, intestinal and peripheral ischemia, Reynaud’s syndrome, thromboembolism, thrombophlebitis Uncommon Hypotension Gastrointestinal disorders: Very common Diarrhoea, nausea and vomiting are observed quite commonly during therapy and may be treated symptomatically.
An anti- emetic may be given for nausea and vomiting. Additionally, events of anorexia, stomatitis (symptoms include soreness, erythema or ulceration of the oral cavity or dysphagia); proctitis, oesophagitis Uncommon Gastrointestinal ulcerations and bleeding (may result in therapy being discontinued) Frequency not known Pneumatosis intestinalis, enterocolitis, colitis (including necrotising colitis) Hepatobiliary disorders: Very common Hepatocellular injury Skin and subcutaneous tissue disorders: Very common Alopecia may be seen in a substantial number of cases particularly in females but is reversible.
Palmar-plantar erythrodysesthesia syndrome has been reported as an unusual complication of high dose bolus or protracted continuous therapy for 5-fluorouracil. The syndrome begins with dysaesthesia of the palms and soles that progress to pain and tenderness.
There is associated symmetrical swelling and erythema of the hand and foot. g. diffuse superficial blue pigmentation, hyperpigmentation, nail dystrophy, pain and thickening of the nail bed, paronychia), dry skin, fissure erosion, erythema, pruritic maculopapular rash, exanthema, photosensitivity, hyperpigmentation of the skin, streaky hyperpigmentation or depigmentation near the veins.
Frequency not known Cutaneous lupus erythematosus General disorders and administration site conditions Very Common Malaise, weakness Frequency not known Fever, vein discolouration proximal to injection sites, local reaction caused by extravasation (pain, swelling, erythema) 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.
Severe toxicity and fatalities are more likely in poor risk patients, but have occasionally occurred in patients who are in relatively good condition. Any form of therapy which adds to the stress of the patient, interferes with nutritional uptake or depresses the bone marrow function, will increase the toxicity of fluorouracil.
If therapy is continued careful monitoring of the patient is required. 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.
Careful consideration should be given to re-administration of Fluorouracil after a documented cardiovascular reaction (arrhythmia, angina, ST segment changes) as there is a risk of sudden death. Cardiac function should be regularly monitored during treatment with fluorouracil.
In case of severe cardiotoxicity the treatment should be discontinued. Immunosuppressant effects/Increased susceptibility to infections Vaccination with a live vaccine should be avoided in patients receiving 5-fluorouracil due to the potential for serious or fatal infections.
Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished. Contact should be avoided with people who have recently been treated with polio virus vaccine. Patients with leukaemia who are in remission should not receive vaccines containing weakened viruses until three months has elapsed since their last chemotherapy session.
Furthermore, immunisation with orally administered vaccines containing the poliomyelitis virus must be postponed for those persons coming into direct contact with the patient, particularly family members. 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. This syndrome has been characterized as a tingling sensation of hands and feet, which may progress over the next few days to pain when holding objects or walking.
The palms and soles become symmetrically swollen and erythematous with tenderness of the distal phalanges, possibly accompanied by desquamation. Interruption of therapy is followed by gradual resolution over 5 to 7 days. Supplementation of chemotherapy with oral pyridoxine has been reported to prevent or resolve such symptoms.
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 […]