Methotrexate for Inflammatory Bowel Disease (IBD)

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Blood test monitoring

Blood tests are required regularly whilst taking Methotrexate. Initially, this is every 2 weeks for the first 4 months and then monthly for 3 months. Once you are on a stable dose, you will need bloods every 3 months.

Why have I been given this leaflet?

The leaflet will help you to remember what your doctor has told you about this medicine. It will also help you to decide whether you want to go ahead with the treatment.

This leaflet aims to provide information regarding Methotrexate for your inflammatory bowel disease (IBD): ulcerative colitis or Crohn’s disease. Methotrexate is sometimes used in Crohn’s disease.

What is Methotrexate and how does it work?

Methotrexate belongs to a group of medicines called immunosuppressants. The immune system is important for fighting infections, but sometimes cells in the immune system attack the body’s own tissues and trigger inflammation like that found in Crohn’s disease and ulcerative colitis. Methotrexate reduces inflammation in the bowel by dampening down over-activity of the immune system.

How do I take this medication?

Methotrexate is taken as a single ONCE A WEEK dose on the same day each week. It can be taken in two different ways – either by tablets or by injection. Injections are often the preferred way to take the drug because there is evidence that taking Methotrexate by injection is more effective and may cause fewer side effects than tablets when treating Crohn’s Disease.

• Tablets: Taken by mouth, after food. The tablets should be swallowed whole with a glass of water while sitting upright or standing. Do not crush or chew them. The tablets usually come as a strength of 2.5mg. You may need to take up to ten tablets a week. Always check the strength of the tablets you get from the pharmacy.
• Injection: injections can be given subcutaneously (under the skin). You can administer this yourself at home using a pen device. You will be shown how to use the pen device at clinic.

If you forget to take your Methotrexate on your normal day, ask your doctor or pharmacist for advice. You may be able to take it up to two days later but should not take it if you are three or more days late. If this happens, take your next dose on your usual day the following week. Do not double up your dose.

The dose of Methotrexate is decided by your consultant. Sometimes doctors recommend starting at a high dose (25mg once a week) to control symptoms then reduce down. Sometimes the Methotrexate is started at a low dose (e.g., 10mg weekly) and gradually increased.

Why have I also been prescribed folic acid?

Folic acid is a vitamin that can help your body cope with Methotrexate and help reduce some of the possible side effects, such as nausea and vomiting. Usually, it is taken once a week, but not on the same day as Methotrexate. However, a number of different regimes may be used, and some people are asked to take folic acid several times a week or every day except the Methotrexate day.

Pregnancy and Breastfeeding

Doctors advise women to use reliable contraception while taking Methotrexate. This is because Methotrexate can cause birth defects or miscarriages. Also, because traces of Methotrexate can remain in body tissue for some time, women are advised to avoid pregnancy for at least 6 months after stopping this drug. Although in the past men were also advised not to try to start a family while taking Methotrexate, there are now several studies showing that there is no increase in risk to babies born where the father was taking Methotrexate at conception.

There is very little evidence to show the effect of Methotrexate on breast milk, but some research shows that the drug passes into breast milk and may affect the baby’s immune system and growth. For these reasons you may wish to be cautious and avoid breastfeeding while taking Methotrexate. If you have any concerns about this, speak to your doctor or IBD team.

When should Methotrexate not be used?

You should find a list of conditions that mean you should not take these medicines in the manufacturers patient information leaflet found in the box of tablets. Please tell your doctor if you have any of the conditions listed in the leaflet.

Do I need any checks before I start treatment?

Before you start treatment, you will need to have blood tests, including liver and kidney tests, as Methotrexate can affect your blood count and sometimes cause liver problems. Your doctor may also request a chest x-ray, lung function tests, or liver scans. If your bone marrow, liver, or kidney function is not working properly, Methotrexate may not be suitable for you.

If there is a possibility you might be pregnant, your IBD team may ask you to complete a pregnancy test.

Do I need any special checks while on Methotrexate?

While taking Methotrexate you will need regular blood test checks of your red blood cells and white blood cells, liver function and kidney function.

It is important that you do not miss your blood tests. You must not take Methotrexate unless you are having regular blood tests. When you start Methotrexate, you will need a blood test every 2 weeks for 4 months, then monthly for 3 months and then every 3 months when your dose is stable.

Are there any Side Effects?

Most medicines cause side effects. The manufacturer’s leaflet contains a list of the known side effects for this medicine. Everyone reacts differently to medicines. You may have some side effects or none at all.

Common side –effects include:

• Feeling sick (nausea), being sick (vomiting) and diarrhoea. These reactions can be especially strong during the first few weeks of treatment. The following suggestions may help: taking the folic acid supplement as prescribed and taking your Methotrexate at a different time of day, for example before you go to bed at night. Switching from the tablets to the injection may also help.
• Headaches, fatigue, mouth ulcers, rash

Other side effects:

Risk of infections

Because Methotrexate acts on the immune system, it can increase your risk of infections. Try to avoid close contact with people who have infections and contact your doctor immediately if you think you have an infection – this includes having a fever, sore throat, and achiness.

Suppression of normal bone marrow function

This can cause a reduction of red blood cells (anaemia), white blood cells (leucopenia) and platelets (thrombocytopenia). This can lead to weakness, breathlessness, and fatigue, being more likely to get infections, and a tendency to bruise or bleed easily. Regular monitoring should pick up a reduced blood count, but it is important that you contact your doctor if you develop an infection of any kind.

Liver inflammation

Your treatment monitoring will include regular liver function tests (LFTs) to check any changes to your liver function. Go to Accident and Emergency if you notice a yellowing of your skin or eyes, which may be a sign of jaundice. Regular blood tests can show up liver damage, but special scans and a biopsy of the liver are sometimes necessary.

Lung inflammation

In rare cases, Methotrexate can affect the lungs. Tell your doctor if you become breathless, have a persistent cough, chest pain or difficulty breathing

Kidneys

Rarely Methotrexate can harm the kidneys. Kidney function will be checked along with your blood count and liver tests.

Allergic reactions

Any medication can cause an allergic reaction and very rarely this can happen with Methotrexate. Symptoms include shortness of breath or swelling of the face or mouth. Rashes may also occur.

There is a slightly increased risk of certain types of cancer such as skin cancer and lymphomas and your doctor should explain this risk before starting treatment. Take care to avoid too much sun,

cover up and use a sunscreen with a high protection factor to reduce the risk of skin cancer.

Will Methotrexate affect any other medicines?

Some medicines interact with Methotrexate and could cause unexpected side effects. Always tell your doctor, dentist, or pharmacist that you are on Methotrexate when they are planning to give you any other medication.

The following medication should be avoided:

• Certain antibiotics: trimethoprim and co-trimoxazole
• Anti-inflammatory painkillers such as aspirin and ibuprofen. Note these are often ingredients in cold remedies you can buy over the counter
• Do not take vitamin or mineral supplements that contain folic acid unless your IBD team has told you to do so.

It is also important to tell your doctor, IBD nurse or pharmacist about any other medicines you are taking or thinking of taking, including over-the-counter medicines, such as cold or flu remedies, multi-vitamins, herbal, complementary or alternative therapies.

You might take Methotrexate at the same time as other treatments for your Crohn’s disease. Your IBD team will discuss whether you need to take more than one treatment. You may take Methotrexate along with steroids during induction treatment. The steroid dose will go down once your symptoms are under control.

Will Methotrexate affect any vaccinations?

Live vaccinations (such as yellow fever or MMR vaccine) should be avoided unless it is advised to be safe for you by the IBD team. Non-live (inactivated) vaccinations may be less effective. The pneumonia, flu and COVID vaccines are all safe and recommended. There is also a non-live shingles vaccine now available that is also safe for you to have.

If you need to have a vaccine while taking this medication talk to your doctor first. They will be able to advise you on what vaccines you can have.

Can I drink alcohol while I am taking Methotrexate?

You can drink alcohol when taking low-dose weekly Methotrexate. However, both alcohol and Methotrexate can damage your liver. Therefore, it is important to stay within the recommended limits (currently 14 units a week).

If you have been diagnosed with liver cirrhosis, then we advise complete abstinence from alcohol (i.e., drink no alcohol).

Where should I store Methotrexate at home?

Store your medication in a cool, dry place away from direct sunlight.

It is important that all medicines are stored out of reach of children.