How does it work?
Tomudex infusion contains the active ingredient raltitrexed, which is a type of chemotherapy medicine for cancer known as a 'cytotoxic antimetabolite'.
Cancers form when cells within the body multiply abnormally and uncontrollably. These cells spread, destroying nearby tissues. Raltitrexed works by stopping the cancer cells from multiplying. It does this by being incorporated into the cells' genetic material, DNA and RNA. Both DNA and RNA are needed for cells to grow, repair themselves and multiply. Raltitrexed causes problems with the production of DNA and RNA in the cancer cells, and this causes the cells to grow in an unbalanced way, resulting in the death of the cells.
Unfortunately, raltitrexed can also affect normal, healthy cells, particularly those that multiply quickly, such as blood cells and hair cells. The most important side effect is on the bone marrow where blood cells are made. Raltitrexed can decrease the production of blood cells, leaving people susceptible to infection. Regular blood tests are therefore needed to monitor the levels of blood cells.
In most chemotherapy regimens, doses are administered in courses at various intervals to allow normal cells to recover from the adverse effects of the anticancer medicines between doses. However, during this period, cancer cells will also recover and start to replicate again. Successful treatment depends on the administration of the next course of therapy before the cancer has regrown to its previous size, with the aimed net effect to decrease the amount of cancer with each successive course of chemotherapy.
What is it used for?
- Advanced cancer of the large bowel and rectum (advanced colorectal cancer) in people who can't have treatment with fluorouracil (5FU) and folinic acid.
How is this treatment given?
- This treatment is given as a drip (infusion) into a vein. The drip usually takes about 15 minutes.
- The treatment may be repeated every three weeks, provided there are no severe side effects.
- The number of doses given in each treatment cycle and the number of cycles you have will depend on how well the cancer responds and how well your body copes with the chemotherapy.
- Chemotherapy medicines can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections, a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
- If you experience diarrhoea during treatment with this medicine, it may be associated with a drop in your blood cell count. Your blood count should be monitored weekly if this happens and your treatment may then need to be stopped, or continued at a lower dose, depending on the results of your blood tests.
- You may feel weak and generally unwell after receiving infusions of this medicine, which may affect your ability to drive or operate machinery safely.
- This medicine may be harmful to an unborn baby. For this reason, women being treated with this medicine should use effective contraception to prevent pregnancy, and men being treated this medicine should use effective contraception to prevent fathering a child, both during treatment, and for up to six months after treatment is finished. Ask your doctor for more information and advice. Women should consult their doctor immediately if they become pregnant.
- Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.
Use with caution in
- Elderly people.
- People whose general condition is poor.
- People with a low number of white blood cells, red blood cells or platelets in their blood, for example as a result of previous chemotherapy or radiotherapy.
- People with decreased kidney function.
- People with decreased liver function (this medicine is not recommended for people with severely decreased liver function).
Not to be used in
- People with severely decreased kidney function.
- People taking leucovorin (folinic acid), folic acid or vitamin preparations containing folic acid (see end of factsheet for more information).
- There is insufficient information regarding the safety and efficacy of this medicine in children. It is not recommended for children.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine is likely to be harmful if used during pregnancy. It should not be used during pregnancy unless considered essential by your doctor for treating life-threatening disease.
- Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least six months after treatment is finished. Seek further medical advice from your doctor.
- It is not known if this medicine passes into breast milk. Mothers who need treatment with this medicine should not breastfeed. Seek medical advice from your doctor.
Very common (affect more than 1 in 10 people)
- Decrease in the number of white blood cells or red blood cells in the blood (leukopenia, neutropenia or anaemia) - see warning section above.
- Fever (high temperature).
- Loss of appetite.
- Feeling or being sick (you will be given medicines to help with this).
- Disturbances of the gut such as diarrhoea, constipation or abdominal pain.
- Feeling weak or tired.
- Elevated liver enzymes.
Common (affect between 1 in 10 and 1 in 100 people)
- Decrease in the number of platelets in the blood (thrombocytopenia).
- Alteration in taste.
- Inflammation of the eyes (conjunctivitis).
- Inflammation of the lining of the mouth, causing a sore mouth or mouth ulcers.
- Hair loss (alopecia).
- Muscle cramps.
- Pain in the joints (arthralgia).
- Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).
- Weight loss.
- Flu-like symptoms.
- Blood infections (sepsis).
- Infection in the tissues under the skin (cellulitis).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines during treatment with this one, to make sure that the combination is safe.
Vaccines may be less effective in people receiving chemotherapy. This is because chemotherapy medicines reduce the activity of the immune system and can prevent the body forming adequate antibodies. Live vaccines should be postponed until at least six months after finishing chemotherapy because they may cause infection. Live vaccines include the following: oral polio; rubella; measles, mumps and rubella (MMR); BCG; chickenpox; yellow fever and oral typhoid vaccines.
There may be an increased risk of side effects if this medicine is used in combination with other medicines which can also suppress bone marrow function and affect blood cell counts, for example other chemotherapy medicines, or the antipsychotic clozapine.
Folic acid and folinic acid (and vitamin preparations containing either of these) may interfere with the action of raltitrexed, and must not be taken immediately before or during administration of this medicine.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain raltitrexed as the active ingredient.