This leaflet contains information about mycophenolate mofetil to treat autoimmune hepatitis.
Dose of mycophenolate mofetil
Blood test monitoring
Blood tests are required regularly whilst taking mycophenolate. Initially, this is every week for the first month, then fortnightly for 2 months, then once a month. Once you are on a stable dose, you will need bloods tests every 3 months.
You can use the box below to record the dates you need to attend to have your blood test.
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.
For most medicines, information is provided by the manufacturer in the medicine package. This leaflet aims to provide more specific information, regarding mycophenolate for your liver condition, than that which is included in the manufacturer’s patient information leaflet found in your box of mycophenolate.
Mycophenolate mofetil is not licensed for autoimmune hepatitis.
Why does mycophenolate mofetil not have a
licence for autoimmune hepatitis?
Sometimes, a medicine has been licensed for a certain use and later use shows that it works for a different illness. The manufacturer can choose whether they apply to the Government to have the more recent information added to the licence. This costs a lot of money so sometimes the manufacturer decides it is not worth their while.
Mycophenolate Mofetil is made by the manufacturer for transplant patients to prevent organ rejection; however, it is also widely used in the treatment of autoimmune hepatitis. Remember that your doctor will have thought carefully about which medicine is best for your condition.
What is mycophenolate mofetil and how does it work?
Your blood contains both white and red blood cells. The white cells in the blood form part of the immune system and these can cause damage to the liver. Mycophenolate helps to reduce the effectiveness of the white blood cells and is used to try to reduce the inflammation and scarring they cause in the liver.
How to take it
Mycophenolate Mofetil is available as a tablet, capsule or suspension. Tablets and capsules should be swallowed whole, do not crush or chew. Ideally, take mycophenolate on an empty stomach.
Mycophenolate pregnancy, breastfeeding and contraception advice
Mycophenolate carries some risks related to pregnancy and breastfeeding.
- You will need a pregnancy test before taking this medication if you are sexually active.
- You must use effective contraception (birth control) whilst taking mycophenolate mofetil and for at least 6 weeks after your last dose. If you have sex with a man, use two reliable forms of contraception at the same time; and
- Talk to your doctor immediately if you think you could be pregnant. Do not stop taking mycophenolate mofetil until you have spoken to your doctor.
For men (including those who have had a vasectomy)
- Male patients or their untreated female partner must use reliable contraception during mycophenolate treatment and for at least 90 days after stopping treatment; and
- Talk to your doctor immediately if you think your partner could be pregnant. Do not stop Mycophenolate Mofetil until you have spoken to your doctor.
For men and women
- Tell your doctor if you are planning a pregnancy.
When should mycophenolate mofetil not be used?
- Do not take this medication if you have a hypersensitivity or allergy to mycophenolate mofetil or mycophenoloic acid.
Do not donate blood whilst you are taking mycophenolate mofetil and for at least 6 weeks after your last dose.
Do I need any special checks while on mycophenolate mofetil?
Mycophenolate mofetil reduces the production of blood cells making you more vulnerable to infections and can sometimes affect the liver. Blood tests will show if you are developing any side-effects. If you are being affected, your treatment will be changed or stopped immediately.
It is important that you do not miss your blood tests. You must not take mycophenolate mofetil unless you are having regular blood tests. When you start mycophenolate mofetil, 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. Your doctor may increase or decrease the number of tablets you take at each dose depending upon the results of your tests.
Are there any side effects?
Mycophenolate can cause a number of side effects, including:
- Feeling sick (nausea) or being sick
- Stomach pains
Whilst you’re taking mycophenolate, tell your doctor or pharmacist straight away if you start experiencing any new symptoms or anything that concerns you. Let them know immediately if you have:
- A sore throat
- A fever
- Flu-like symptoms
- A constant cough or problems breathing
- The sensation that your heart is beating unusually
- Sudden weight loss
- Unexplained bruising or bleeding
- Unexplained changes in mood
- Headaches – particularly if you don’t usually get them
- Acne or a skin rash
- Swollen gums or an unusual taste in your mouth.
If any of these symptoms are severe, your doctor may advise you to stop taking mycophenolate. However, it is always best to talk to your doctor or a member of your liver team before making any changes to your treatment. You should see your doctor as soon as possible if you come into contact with anyone with shingles or chickenpox, or if you get them yourself. These infections can affect you badly if you are on mycophenolate. You may need antiviral treatment, and your mycophenolate may be stopped until you are better.
Although it is uncommon, there is a slightly increased risk of certain types of cancer, such as skin cancer, in people using mycophenolate. However, the link between the two is unclear.
Take extra care on sunny days when there are high levels of UV and sunlight. Sunscreen with a high protective factor should be applied and protective clothing worn such as long sleeves and trousers.
Very rarely, patients treated with mycophenolate can develop a serious condition called progressive multifocal leukoencephalopathy (pro-gress-iv mul-tee-fo-cul loo-ko-en-kef-a-lop-afy), also known as PML, which can damage the brain and spinal cord. You must see your doctor immediately if you notice any of the following symptoms:
- Pins and needles
- Weakness, shaky movements or unsteadiness
- Sight loss
- Speech problems
- Changes in behaviour or mood
- Difficulty moving your face, arms or legs.
Will mycophenolate mofetil affect any other medicines?
Full information on medicines that can interfere with mycophenolate can be found in the manufacturer’s patient information leaflet found in your box of mycophenolate. If you take any of these medicines, tell your doctor or pharmacist and they will advise you.
Tell your doctor or pharmacist about all the other medicines you take. This includes any medicines you have had prescribed by another doctor as well as medicines bought from a pharmacy or supermarket and any vitamins or herbal remedies.
Whenever you are prescribed a new medicine or want to buy a medicine, for example, from a pharmacy or supermarket, it is important that you tell the doctor or pharmacist about all the medicines that you take, including mycophenolate mofetil. You should also tell your dentist when you see him or her.
For additional information please refer to the patient information leaflet supplied with your medicine or refer to www.medicines.org.uk for the full summary of the product characteristics.
Will mycophenolate mofetil affect any vaccinations?
Live vaccinations such as yellow fever or shingles vaccine should be avoided in patients treated with mycophenolate mofetil. Non-live (inactivated) vaccinations may be less effective. The pneumonia, flu and COVID vaccines are all safe and recommended.
Can I drink alcohol while I am taking mycophenolate mofetil?
Yes, it is safe to drink alcohol while you are taking Mycophenolate Mofetil; however, large quantities of alcohol should be avoided. It is recommended that you do not exceed the national guidelines. Government guidelines say both men and women should have no more than 14 units of alcohol a week and that you should spread these through the week rather than having them all in one go.
Where should I store mycophenolate mofetil at home?
Store mycophenolate mofetil in a cool, dry place away from direct sunlight..
South Tees Hospitals NHS Foundation Trust would like your feedback. If you wish to share your experience about your care and treatment or on behalf of a patient, please contact The Patient Experience Department who will advise you on how best to do this.
This service is based at The James Cook University Hospital but also covers the Friarage Hospital in Northallerton, our community hospitals and community health services.