Fluorouracil 25 mg / ml injection – patient leaflet, side effects, dosage

1. What Fluorouracil Injection is and what it is used for

Fluorouracil Injection is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Fluorouracil Injection is used to treat many common cancers, particularly cancers of the large bowel and breast. It may be used in combination with other anti-cancer medicines or radiotherapy.

2. What you need to know before you use Fluorouracil Injection

Do not use Fluorouracil Injection

• if you are allergic to Fluorouracil or any of the other ingredients of this medicine (listed in section 6)

• if you are in a seriously weakened (including nutritional) state due to long illness

  Some patients may experience a sensitivity to light following administration of fluorouracil, it is recommended to avoid prolonged exposure to sunlight (see section 4).

• if your bone marrow has been damaged by other cancer treatments (including radiotherapy)

• if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency)

  Patients undergoing radiotherapy are at an increased likelihood of necrosis (death of tissue or skin) caused by radiation.

• if you have a potentially serious infection

• if your cancer is non-malignant

  If you have had leukaemia and are in remission do not take live vaccines before 3 months after your last chemotherapy. Also you and people in your direct contact such as family members should not take a polio vaccine.

• if you are breast-feeding

• if you are taking or have taken in the past 4 weeks brivudine, sorivudine and similar drugs (antivirals)

  The administration of fluorouracil has been associated with the occurrence of hand-foot syndrome. 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 swollen and tender.

Tell your doctor if any of the above applies to you before this medicine is used. Warnings and precautions

Talk to your doctor or pharmacist before using Fluorouracil Injection

• if your bone marrow is not producing blood cells normally (your doctor will do a blood test to check this)

  Other medicines and Fluorouracil Injection

  Special care is needed if you are taking/using other medicines as some could interact with Fluorouracil Injection, for example:

  • methotrexate, cisplatin, cytarabine, mitomycin-C, tamoxifen (anti-cancer medicines)
  • metronidazole (an antibiotic)
  • calcium leucovorin (also called calcium folinate - used to reduce the harmful effects of anti-cancer medicines)
  • allopurinol (used to treat gout)
  • cimetidine (used to treat stomach ulcers)
  • warfarin (used to treat blood clots)
  • interferon alpha 2a; brivudine, sorivudine and similar drugs (antivirals)
  • phenytoin (an anti-epilepsy medicine)
  • vaccines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You may need to be monitored, and your dose of Fluorouracil Injection may be adjusted when given with leucovorin (also called calcium folinate).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Women must avoid becoming pregnant and use a highly effective method of contraception during treatment with Fluorouracil and for at least 6 months afterwards. Men treated with Fluorouracil are advised not to father a child during and for up to 3 months following end of treatment. Men and women should both seek advice on fertility preservation such as conservation of eggs or sperm before treatment because of the possibility of irreversible infertility due to therapy. Fluorouracil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

If pregnancy occurs during your treatment you must inform your doctor and should seek genetic counselling.

Genetic counselling should be offered if you are planning to become pregnant after your treatment. Since it is not known whether fluorouracil passes into breast milk, breast-feeding must be discontinued before treatment with Fluorouracil Injection.

Driving and using machines

Do not drive or use machines if you experience any side effect from Fluorouracil, such as nausea and vomiting. Fluorouracil can also produce adverse events on your nervous system and cause visual changes. If you experience any of these effects, do not drive or use any tools or machines, as they may impair your ability to do so.

Fluorouracil Injection contains sodium

The 10 ml vial contains 40.1 mg of sodium (main component of cooking/table salt) in each vial. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

Fluorouracil is an irritant, contact with skin and mucous membranes should be avoided. In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat the transient stinging of the skin. Medical advice should be sought if the eyes are affected or if the preparation is inhaled or ingested. The 20 ml vial contains 80.2 mg of sodium (main component of cooking/table salt) in each vial. This is equivalent to 4% of the recommended maximum daily dietary intake of sodium for an adult. The 100 ml vial contains 401 mg of sodium (main component of cooking/table salt) in each vial. This is equivalent to 20% of the recommended maximum daily dietary intake of sodium for an adult.

Fluorouracil 25 mg/ml Injection The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Incompatibilities

3. How to use Fluorouracil Injection

Formulated solutions are alkaline and it is recommended that admixture with acidic drugs or preparations should be avoided.

This medicine is given into a vein or an artery. If it is given into a vein, it can either be injected (using a syringe) or infused (using a drip). If it is given into an artery, it will be given as an infusion. If it is to be given as an infusion the medicine will be diluted before use.

Fluorouracil Injection is reported to be incompatible with cytarabine, diazepam, methotrexate, platinum compounds, doxorubicin (and presumably other anthracyclines that are unstable at alkaline pH), and calcium folinate (leucovorin).

Dose

Your doctor will work out the correct dose of Fluorouracil Injection for you and how often it must be given. The dose of medicine given to you will depend on your medical condition, your size, if you have had recent surgery and how well your bone marrow, liver and kidneys are working. Your doctor will tell how well your bone marrow, liver and kidneys are working using blood tests. The total daily dose should not exceed 1 gram.

Use and handling, and disposal

The pH of Fluorouracil Injection is 8.9 and the drug has maximal stability over the pH range 8.6 to 9.0. If a precipitate has formed as a result of exposure to low temperatures, re-dissolve by heating to 60°C accompanied by vigorous shaking. Allow to cool to body temperature prior to use. The product should be discarded if it appears brown or dark yellow in colour or if particles are visible. Fluorouracil Injection may be diluted with Glucose 5% Injection or Sodium Chloride 0.9% Injection or Water for Injections immediately before use.

If you are given too much or too little Fluorouracil Injection

This medicine will be given to you by a doctor or nurse. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns. If you have taken too much, your doctor will monitor you closely for at least 4 weeks.

Fluorouracil injection should not be mixed directly, in the same container, with other chemotherapeutic agents or intravenous additives.

4. Possible side effects

Chemical and physical in-use stability has been demonstrated for 5 days at 20-21°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Like all medicines, fluorouracil can cause side effects, although not everybody gets them. If any of the following happen, tell your doctor immediately:

• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

  Cytotoxic Handling Guidelines

  Should be administered only by, or under the direct supervision of, a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

• chest pains (which may be due to heart problems, including having a heart attack)

• shortness of breath

  Fluorouracil Injection should only be prepared for administration by professionals who have been trained in the safe use of the preparation. Preparation should only

• your bowel motions are bloodstained or black

• your mouth becomes sore or develops ulcers

  be carried out in an aseptic cabinet or suite dedicated for the assembly of cytotoxics. In the event of spillage, operators should put on gloves, face mask, eye protection and disposable apron and mop up the spilled material with an absorbent material

• symptoms of leucoencephalopathy (disease of brain) – extreme weakness and fatigue, staggering while walking, thinking or speech difficulties, seizures, coma. These are very serious side effects. You may need urgent medical attention. The frequency of possible side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people

  kept in the area for that purpose. The area should then be cleaned and all contaminated material transferred to a cytotoxic spillage bag or bin and sealed for incineration.

  Contamination

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

• blood clots (pain, redness or swelling of the part affected) Please refer to the marketing authorisation holder for COSHH hazard datasheets. Preparation Guidelines

If you experience any of the following tell your doctor as soon as possible: Very common side effects

1. a)

   Chemotherapeutic agents should be prepared for administration only by professionals who have been trained in the safe use of the preparation.

   • infections
   • increased chance of picking up infections and/or delayed wound healing due to low white blood cells
2. b)

   Operations such as reconstitution of powder and transfer to syringes should be carried out only under aseptic conditions in a suite or cabinet dedicated for the assembly of cytotoxics.

   • anaemia (reduction in red blood cells)
3. c)

   The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield.

   • difficulty breathing
   • abnormality in the heart’s rhythm
4. d)

   Pregnant personnel are advised not to handle chemotherapeutic agents. Disposal

   • diarrhoea
   • feeling or being sick

Syringes containing remaining solution, absorbent materials, and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated at 700°C.

• anorexia (loss of appetite)
• inflammation of the lining of the mouth, throat, gut, rectum or anus
• hair loss (reversible especially in women)
• reddening, swelling or pain in the palms of the hands and/or the soles of the feet • tiredness
• feel generally unwell
• weakness
• liver cell damage

Common side effects

• low white blood cells accompanied by fever
• chest pain

Uncommon side effects

• feeling of intense excitement and happiness
• watering eyes, changes in vision, sensitivity to light, side-to-side movements of the eyes • headache
• dizziness
• symptoms of Parkinson’s disease (e.g. shaking hands)
• numbness, tingling or tremor in the hands or feet
• sleepiness
• irregular heart beat, palpitations
• low blood pressure (you may feel faint)
• skin problems (including dry skin, itchy weals, rash, redness, inflammation)
• skin may appear lighter or darker, may occur in patches
• changes in your nails, such as changes in colour or thickening of the nails
• sensitivity of the skin to light

Rare side effects

• serious allergic reaction causing difficulty breathing or dizziness
• feeling confused
• reduced blood supply to the brain, intestines and extremities (ischaemia)

• discolouration in your fingers and toes (Raynaud’s syndrome)

  Very rare side effects

  • disorientation
  • muscle weakness
  • brain disorders have been reported causing uncontrollable movements, difficulty speaking, fits and coma
  • kidney failure
  • cardiac arrest
  • sudden cardiac death

Frequency unknown

• a disorder of the nerves which can cause weakness, tingling or numbness
• hyperammonaemic encephalopathy (brain dysfunction caused by elevated ammonia)
• condition characterised by headache, confusion, seizures and changes in vision (posterior reversible encephalopathy syndrome [PRES])
• heart disease that presents with chest pain, shortness of breath, dizziness, fainting, irregular heartbeat (stress cardiomyopathy)
• faster heart beat
• inflammation of the outer lining of the heart
• breathlessness
• fever
• the vein where fluorouracil is administered may become painful or discoloured, which may be the sign of a blood clot
• inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints and fever (cutaneous lupus erythematosus [CLE])
• air in the intestinal wall
• serious condition that presents with difficulty breathing, vomiting and abdominal pain with muscle cramps (lactic acidosis)
• serious complication with rapid break down of cancer cells causing high levels of uric acid, potassium and phosphate (tumour lysis syndrome)
• high blood levels of triglycerides, a type of fat
• pain, redness or swelling at the infusion site during or shortly after the injection/infusion (may be due to the injection not going into the vein properly)
• vitamin B1 deficiency and Wernicke’s encephalopathy (brain damage caused by vitamin B1 deficiency)
• inflammation in the small and large bowel causing pain and diarrhoea, which can lead to death of bowel tissue (colitis, enterocolitis)
• Inflammation of the heart muscle

• Heart problems that can cause quickening of your heart rate and breathlessness Fluorouracil may lead to changes in your blood cells. Your doctor will take blood samples to check for abnormalities (e.g. bone marrow depression which may result in low white cells, low red cells, low platelets, low gamma globulins).

  Reporting of side effects

  If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluorouracil Injection

Keep out of the sight and reach of children

Expiry

This medicine must not be used after the expiry date which is stated on the vial label and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage

Keep the vials in the outer carton, in order to protect from light and store at or below 25°C. They should not be refrigerated or frozen.

Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 5 days provided they have been prepared in a way to exclude microbial contamination.

Visible signs of deterioration

Do not use this medicine if you notice it appears brown or dark yellow in colour, or if particles are visible.

Disposal

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fluorouracil Injection contains

The active substance is fluorouracil. Each millilitre (ml) of solution contains 25 mg of fluorouracil.

The other ingredients are sodium hydroxide (see section 2 “Fluorouracil Injection contains sodium”) and Water for Injections.

What Fluorouracil Injection looks like and contents of the pack

Fluorouracil Injection is a clear, colourless or slightly yellow solution for injection without visible particles, which comes in glass containers called vials.

It may be supplied in packs containing:

• 5 x 250 mg/10 ml vials
• 10 x 500 mg/20 ml vials
• 1 or 10 x 2.5 g/100 ml vial(s)

Not all packs may be marketed.

Marketing Authorisation Holder

Hospira UK Limited

Walton Oaks, Walton-On-The-Hill Dorking Road, Tadworth, Surrey KT20 7NS

UK

Manufacturer

Pfizer Service Company BV

Hermeslaan 11, 1932 Zaventem, Belgium This leaflet was last revised in 02/2026.

Ref: gxFU 22_0

Fluorouracil 25 mg/ml Injection

2025-1006963B