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At a glance
- Treatment
- Raltitrexed; Tomudex
- Used in selected settings
- Selected advanced colorectal cancer when fluorouracil-based treatment is unsuitable
- How it is given
- An infusion into a vein, usually over about 15 minutes. The full visit also includes assessment, blood-test review and supportive treatment.
- Before you start
- Save your 24-hour oncology number. Have a thermometer and written treatment calendar available.
Report new diarrhoea or mouth soreness promptly, even if it seems mild. With raltitrexed these can be early signs of serious toxicity, including low blood counts. Do not wait for the next appointment or for a fixed number of stools before asking for advice.
What this treatment is and how it works
Raltitrexed is an antifolate chemotherapy medicine. It blocks an enzyme called thymidylate synthase, which cells need to make DNA. Without this building material, cancer cells have difficulty growing and dividing.
When it may be used
It is used for selected people with advanced colorectal cancer when treatment based on fluorouracil (5-FU) and folinic acid is not suitable or has not been tolerated. Treatment generally aims to control the cancer and symptoms.
It may be chosen after a specific problem with a fluoropyrimidine, but it is not automatically a safe substitute for every patient and has its own potentially serious toxicities. Your oncologist will consider kidney function, general health and the reason the earlier treatment was unsuitable. Specialist combinations require their own treatment calendar.
Licences and access differ by country and product. This sheet does not establish Indian regulatory approval or availability. Your oncologist will explain the locally appropriate treatment.
Before treatment
Before starting, tell the team about previous cancer treatment, allergies, infection symptoms, heart, lung, kidney or liver disease, hearing or nerve problems, diabetes and all medicines you take. Discuss pregnancy, contraception and fertility. Ask for a written treatment calendar, supportive-medicine instructions and a 24-hour oncology contact number. Baseline blood tests usually include a full blood count and kidney and liver function; additional tests depend on the medicine and your health. Before chemotherapy that reaches the whole body, the team should check for current or past hepatitis B infection. If a test is positive, extra monitoring or antiviral treatment may be needed to prevent the virus becoming active again. The team will coordinate testing and treatment; do not delay urgent cancer treatment yourself.
How treatment is given and the schedule
An infusion into a vein, usually over about 15 minutes. The full visit also includes assessment, blood-test review and supportive treatment.
Treatment is commonly repeated every 3 weeks. Reduced kidney function can require a lower dose and a longer interval, often 4 weeks. Treatment should not simply proceed because the planned date has arrived: symptoms and tests must be reviewed first.
The number of cycles depends on how well the cancer is controlled and how you tolerate treatment. Tell the team about all diarrhoea, mouth soreness or vomiting since the last dose, even if it has settled.
The dose is calculated for your treatment and health. Do not change the dose or treatment dates yourself. The team will provide a revised calendar if treatment needs to be delayed, reduced or stopped.
Tests and monitoring during treatment
- A full blood count, kidney function and liver blood tests are checked before the first dose and each further cycle. The team assesses kidney clearance, not just whether the creatinine result appears within a laboratory’s normal range.
- Age, low muscle mass or weight loss can make a seemingly normal creatinine result misleading. Raltitrexed is cleared partly by the kidneys; accumulation can cause severe toxicity. It must not be used in severe kidney impairment under the referenced SmPC.
- Diarrhoea or vomiting can cause dehydration and worsen kidney function. If gut symptoms develop, blood counts may need checking at least weekly and sometimes more often. The next dose is delayed until toxicity has resolved sufficiently, with a reduced dose or treatment change when required. Scans and clinical review assess benefit.
Tell the team about symptoms since the previous dose, including problems that have already settled. A normal earlier test does not make new symptoms safe to ignore.
Side effects: what to expect
The table groups very common and common effects in Tomudex information for advanced colorectal cancer. Low white cells and anaemia are very common; low platelets are common. The risk of severe toxicity changes with kidney function, dehydration, dose and other treatment.
You are unlikely to have every effect listed, and this is not an exhaustive list. Report new symptoms even if they are not mentioned here.
Common or more frequent side effects
| Possible effect | What you can do | When to contact the team |
|---|---|---|
| Low blood counts | White cells fight infection, red cells carry oxygen and platelets help clotting. Treatment can lower one or more of these. Wash hands, avoid close contact with people who are unwell and keep blood-test appointments. | Call immediately for fever, shaking chills or feeling suddenly unwell. Report unusual bruising, bleeding, marked tiredness or increasing breathlessness. Do not wait for a blood-test result before seeking help. |
| Feeling or being sick | Take preventive anti-sickness medicines at the prescribed times. Try small meals and frequent small drinks; avoid strong food smells if they worsen nausea. | Contact the team the same day if medicines are not controlling symptoms. Seek urgent advice if you cannot keep fluids down, feel faint or pass much less urine. |
| Constipation | Keep a bowel record. Gentle movement, usual fluids and a prescribed laxative can help. Ask before using suppositories or enemas when blood counts may be low. | Contact the team for worsening constipation. A swollen or painful abdomen, vomiting or inability to pass wind needs urgent assessment; do not simply add laxatives. |
| Tiredness and reduced stamina | Balance rest with short periods of gentle activity. Prioritise tasks and accept help with shopping, meals or transport. Tell the team about poor sleep or pain. | Report fatigue that prevents basic activities or is worsening. Sudden breathlessness, chest pain, fainting or confusion needs urgent assessment. |
| Reduced appetite or changes in eating | Try smaller, frequent meals with protein and energy-rich foods you tolerate. Ask for a dietitian if your weight or intake is falling. | Report ongoing weight loss or difficulty eating. Inability to drink or signs of dehydration needs same-day urgent advice. |
| Changes in liver blood tests | Attend blood tests even if you feel well. Check medicines and supplements with the pharmacist. | Report yellow eyes or skin, dark urine, severe upper-abdominal pain or confusion urgently. The team may need to pause or change treatment. |
| Diarrhoea or increased stoma output | Begin the team’s agreed fluid and symptom plan. Keep a stool or stoma-output record. Do not self-treat repeatedly without reporting the problem. | Contact the team promptly at the first new diarrhoea or increased output. Fever, blood, severe cramps, dizziness or reduced urine needs urgent assessment. |
| Mouth soreness or ulcers | Use a soft toothbrush, gentle mouth care and rinses recommended by the team. Choose soft, non-irritating foods. | Report new soreness promptly rather than waiting until you cannot eat. Difficulty swallowing fluids, fever or severe pain needs urgent advice. |
| Rash or itching | Use gentle skin care and a plain moisturiser. Check before applying a medicated cream. | Report new or worsening rash. Painful peeling skin, blisters or mouth or eye involvement needs urgent assessment. |
Other reported side effects (frequency varies)
Taste changes, headache, cramps, sore or red eyes, hair thinning, joint aches and ankle swelling can occur and are classed as common in the SmPC. Skin peeling is uncommon. The frequency of gastrointestinal bleeding is not established. Fever or flu-like symptoms must be assessed for infection rather than assumed to be a harmless reaction.
Important serious side effects, including rare effects
Serious effects can be common, uncommon, rare or have an uncertain frequency. The following advice explains when to seek help; it does not label all serious effects as rare.
Severe gut and bone-marrow toxicity
Diarrhoea or mouth inflammation can occur together with a dangerous fall in blood cells. Call promptly for any new gut symptoms. Fever, severe abdominal pain, blood in stools, inability to drink or sudden deterioration needs urgent assessment. The team may need to arrange hospital treatment; do not wait for the next cycle.
Dehydration and kidney injury
Repeated vomiting or diarrhoea, dizziness, dry mouth and reduced urine may indicate dehydration. This can slow removal of raltitrexed and worsen toxicity. Seek urgent advice if you cannot keep fluids down or pass much less urine. Do not force extra fluids if you have a fluid restriction; get an individual plan.
Sepsis or serious bleeding
Fever, shaking chills or sudden illness requires immediate contact. Uncontrolled bleeding, black stools, vomiting blood, collapse, severe breathlessness or new confusion needs emergency help.
Severe reaction during or after an infusion
Tell staff immediately about flushing, a new rash, dizziness, wheezing or swelling. Breathing difficulty, face or throat swelling or collapse is an emergency. Report pain or swelling around the infusion site.
Practical advice for this treatment
Keep the 24-hour hospital number accessible throughout the whole cycle. Do not dismiss symptoms because the infusion was short or several days ago. Have prescribed anti-sickness medicines, a thermometer and a written diarrhoea plan ready. Check vitamin and supplement labels for folic acid or folinic acid and show them to the oncology pharmacist.
Medicines, interactions and vaccinations
Give the oncology pharmacist a complete list of prescription medicines, over-the-counter products, vitamins, herbal and Ayurvedic remedies and supplements. Ask before starting anything new. Do not stop prescribed medicines, including anticoagulants or infection-prevention medicines, without a coordinated plan. Live vaccines are generally unsuitable while immunity is suppressed; discuss vaccine type and timing with the team. Non-live vaccines may be offered, although protection can be reduced. Follow any specific stop-and-call instructions for the cancer medicine on this page or in your written treatment plan.
Do not take folic acid, folinic acid (leucovorin), or vitamin preparations containing them with raltitrexed unless the oncology team specifically directs this. They can interfere with treatment. This is different from the routine vitamin plan used with pemetrexed. A specialist may use folinic acid as rescue treatment for severe toxicity or overdose; that is a hospital decision, not a home remedy. Review painkillers, anticoagulants and medicines that may affect the kidneys, as well as herbal or Ayurvedic products. There is no need to avoid ordinary folate-containing foods.
Pregnancy, fertility and breastfeeding
Chemotherapy can harm a developing baby and may affect fertility temporarily or permanently. Discuss sperm, egg or embryo storage before treatment when feasible. Tell the team immediately about a suspected pregnancy. Periods stopping does not guarantee infertility.
The Tomudex SmPC advises avoiding pregnancy during treatment and for at least 6 months afterwards if either partner receives raltitrexed. Use effective contraception and ask for a written end date that also covers any accompanying medicines. Fertility may be affected. Raltitrexed must not be given during pregnancy or breastfeeding; discuss feeding alternatives and any later restart with the team.
Everyday life
Gentle activity, regular meals and rest can help you cope. Prepare food hygienically and drink according to your individual fluid plan. Avoid smoking; ask whether alcohol is safe with your exact treatment and other medicines. Plan work, travel and driving around symptoms and monitoring visits. Do not drive if dizzy, sleepy, weak, visually affected or impaired by neuropathy. You can usually be close to family and friends: chemotherapy does not make you radioactive. Follow the unit’s instructions for handling urine, vomit, laundry and sexual precautions for the period it specifies.
When to contact the oncology team
Contact the oncology team the same day for any new diarrhoea or mouth soreness, vomiting, difficulty drinking, reduced urine, mouth pain affecting eating, new cough, jaundice, a painful or spreading rash, unusual bruising, worsening constipation or new nerve symptoms. Use the more urgent instructions for the particular symptom when given above. If the team cannot be reached and you are unwell, seek urgent medical care.
Write down your hospital’s daytime and out-of-hours numbers before treatment. CTI’s general contact details do not replace the emergency number provided by your treating hospital.
After treatment
Keep the planned blood tests and follow-up appointments after the last dose. Blood counts and immunity may take time to recover, and some effects can start or persist later. Contact the team about symptoms rather than waiting for a routine visit. Keep a treatment summary, including drug names, dates and any serious reactions, for future doctors. Response may be assessed with examination, scans or blood or marrow tests, depending on the cancer.
Words you may hear
- Antifolate
- A medicine that interferes with a folate-dependent process needed for cell growth.
- Kidney clearance
- An estimate or measurement of how effectively the kidneys remove substances from the blood.
- Mucositis
- Inflammation or soreness of the lining of the mouth or digestive tract.
Frequently asked questions
Why might raltitrexed be chosen instead of 5-FU or capecitabine?
It may be considered when a fluoropyrimidine-based treatment is unsuitable. The reason matters, and your oncologist must weigh raltitrexed’s own risks and alternatives.
Do I need folic acid tablets as with pemetrexed?
No. Do not carry over a pemetrexed vitamin plan. Folic acid and folinic acid supplements can interfere with raltitrexed; check all preparations with the pharmacist.
Do I need to stop eating green vegetables?
No. The warning concerns supplements or medicines containing folic or folinic acid, not a restriction on ordinary foods. Ask for dietary advice if your intake is poor.
Why call about mild diarrhoea?
It can be an early warning of more serious toxicity. The team may need blood tests, extra fluids or a change to treatment before symptoms worsen.
Why is a normal creatinine result not always enough?
Age, low muscle mass and weight loss affect the result. The team assesses how well your kidneys actually clear medicines before choosing the dose and interval.
Can I still receive treatment if my mouth was sore last week?
Tell the team even if it is now better. The severity of the previous reaction helps determine whether to delay or reduce the next dose.
Will I definitely lose my hair?
Hair thinning or loss can occur, but complete hair loss is not inevitable. The overall risk depends on any accompanying drugs.
Is a 15-minute infusion a mild treatment?
No. Infusion length does not measure risk. Serious side effects can appear days later, so monitoring and prompt symptom reporting remain essential.
Related treatment information
If this medicine is combined with other treatments, ask for each medicine’s information and the complete combination calendar. An individual-drug sheet does not describe every additional risk of a combination.
Sources and further reading
Summary of Product Characteristics
Professional reference resources. The SmPC describes product-specific warnings, interactions, adverse effects and monitoring. US prescribing information is identified separately. Original-brand or direct manufacturer documents are linked where retrieved. The team must also check the product actually supplied in India.
- Tomudex — company-supplied UK SmPC, Hospira UK (Pfizer). Accessed 16 October 2026. Original-brand product information; text revised March 2024. Company-supplied SmPC on emc, not a separately retrieved manufacturer-hosted PDF.
Other authoritative references
- Macmillan Cancer Support — Raltitrexed. Accessed 16 October 2026. Patient care, treatment and adverse effects.
- BC Cancer — Raltitrexed monograph. Accessed 16 October 2026. Revised 1 June 2013. Historical independent cross-check; current SmPC governs warnings and monitoring.
- NCI — infection and neutropenia. Accessed 16 October 2026.
- NCI — mouth and throat problems. Accessed 16 October 2026.
- NCI — diarrhoea. Accessed 16 October 2026.
- NCI — fatigue. Accessed 16 October 2026.
- ASCO hepatitis B screening and management opinion. Accessed 16 October 2026. Independent cross-check: Provisional Clinical Opinion: universal three-test screening before or at systemic anticancer therapy; chronic/past infection management.
Editorially approved by Dr (Prof) Vijay Agarwal
Professor and Lead Consultant – Medical Oncology
