Mycophenolate

What is mycophenolate?

Mycophenolate is converted in the body to mycophenolic acid, which is used to treat immune-related diseases like systemic lupus erythematosus (lupus or SLE), autoimmune vasculitis (inflammation of blood vessels), inflammatory bowel disease such as Crohn’s disease, and other kidney or skin disorders. These medicines are also used to prevent transplant rejection in people who have had organ transplants.

It is an immunosuppressant, which means that it works by reducing the activity of the immune system. In kidney disease caused by SLE, this  helps to reduce inflammation in the kidneys and reduce protein loss in urine and helps stabilise kidney function.

What benefit can you expect from your treatment?

Mycophenolate is useful in many autoimmune diseases. It does not work straight away. You may start to notice less symptoms after four weeks. The effects to delay or prevent damage may take several months.

If mycophenolate works well and doesn’t cause serious side effects, the treatment can be continued for as long as needed.

If you stop mycophenolate treatment for more than a few weeks, there is a risk that your condition may worsen. Continue with your treatment unless advised by your doctor or unless side effects develop.

Other medicines may be given to improve your symptoms while waiting for this medicine to work.

How is mycophenolate taken?

Mycophenolate is taken by mouth as a tablet, capsule or liquid usually twice a day. Taking the medicine in the evening or at mealtimes may help to reduce nausea (see possible side effects). It can be given as a liquid if the tablets are hard to swallow. You should not break or crush the tablet/capsule(s). Speak to your doctor or pharmacist if you have problems swallowing.

Mycophenolate mofetil tablets come in strengths of 250mg in capsule form or 500mg in tablet form. The liquid contains 1g in 5mls.

Mycophenolate sodium tablets come in strengths of 180mg or 360mg.

Mycophenolate mofetil and mycophenolate sodium are NOT directly interchangeable. Treatment usually starts with a low dose, which is increased and adjusted depending on the response and side effects.

Mycophenolate may be taken in combination with other arthritis medicines, including:

• other disease modifying anti-rheumatic drugs (DMARDs)
• steroid medicines such as prednisolone or cortisone injections into the joint
• anti-inflammatory medicines (NSAIDs) such as naproxen (Naprosyn) or ibuprofen (Brufen/Nurofen)
• pain medicines such as paracetamol.
• There are separate information sheets for the medicines mentioned above.

Are there any side effects?

You might experience side effects with your treatment. Tell your doctor if you are concerned about possible side effects.
A lower dose may minimise side effects so that you can continue to take your medicine. Your doctor will tell you if you need to change your dose.

Most common possible side effects

• The most common side effects are nausea, vomiting and diarrhoea. These can be reduced if mycophenolate is taken with food or in the evening. Anti-nausea tablets can be used if needed.
• Headache, dizziness, difficulty sleeping, tremor and rash can occur.
• Patients older than 65 may be at increased risk of some side effects, especially infections and gastrointestinal bleeding.
• People who have had stomach ulcers or other serious gastrointestinal conditions should talk with their doctor before taking this medicine.

Less common or rare possible side effects

There are some rare but potentially serious side effects with mycophenolate.

• Blood counts: Mycophenolate can rarely cause a drop in the number of white blood cells, which are needed to fight infection. It can also cause a drop in the number of platelets, which help to stop bleeding. Very rarely red blood cells can be affected.
  Regular blood tests should pick these problems up early if they occur. However, if you develop a sore mouth, mouth ulcers, easy bruising, nosebleeds, bleeding gums, breathlessness, infection or fever, tell your doctor immediately. 
• Liver: Mycophenolate can inflame the liver. Regular blood tests aim to pick this up early if it occurs. The dose of mycophenolate may need to be reduced or stopped if problems occur. Liver problems may be increased when mycophenolate is combined with other medicines or with heavy alcohol use (see Alcohol).
• Cancer: see Long-term possible side effects

Long term possible side effects

Mycophenolate may be taken for long periods to manage immune conditions. In addition to possible effects mentioned above, the following are rare but possible long term side effects:

• Cancer: Studies of transplant patients taking mycophenolate have found it may increase risk of some cancers such as lymph node cancers (lymphomas) and skin cancers (see Precautions overleaf). You should discuss this with your rheumatologist before starting the medicine. For general cancer prevention, you should quit smoking.
• Mycophenolate does not affect a person’s fertility in the long term. See ‘Precautions’.

More information about possible side effects

The information sheet that comes with your mycophenolate will also outline in detail potential serious side effects. Many of those side effects relate to the use of higher doses used to prevent transplant organ rejection. These may not be applicable to the much lower doses that are prescribed for the treatment of rheumatic diseases. Talk to your doctor if you have concerns about any possible side effects.

What precautions are necessary?

Blood tests

• Since mycophenolate can affect the liver and blood cells, you must have regular blood tests during your treatment. This is very important, as you may not get symptoms.
• As well as monitoring for side effects, blood tests help to monitor your condition to determine if the treatment is effective.
• You will need to have full blood counts and liver function tests every 2 to 4 weeks for the first few months of treatment and then every 1 to 3 months after that.
• If no issues are found after 3 months of treatment with a certain dose of mycophenolate, blood tests might be needed less often.
• Your general practitioner (GP) will be informed about the monitoring schedule. It is important to see your GP if you have been asked to do so as they have an important

Risk of infections

• Because your immune system may be suppressed, there is an increased risk of developing some infections, especially herpes zoster (chicken pox and shingles). You should try to avoid contact with people who have these infections. If you have an infection or persistent fever, tell your doctor straight away.

Use with other medicines

• Mycophenolate can interact with other medicines. You should tell your doctor (including your GP, rheumatologist and others) about all medicines you are taking or plan to take. This includes over-the-counter or herbal/naturopathic medicines. You should also mention your treatment when you see other health professionals.
• Some medicines that may interfere with mycophenolate include:
  • aciclovir (Zovirax)
  • azathioprine (Imuran)
  • antacids containing magnesium or aluminium hydroxide (e.g. Mylanta)
  • antibiotics like ciprofloxacin and amoxicillin with clavulanic acid
  • oral contraceptives
  • phenytoin (Dilantin)
  • probenecid (Procid)
  • theophylline (Theo-Dur).
• Aspirin can be used safely in the low doses.
• Mycophenolate can be taken safely with anti-inflammatory drugs (NSAIDs), as long as your kidney function is normal.
• Because many antacids interfere with the absorption of mycophenolate, they should not be taken at the same time. Instead, you should take antacids at least 1 hour before or 2 hours after taking mycophenolate.

Vaccination

• If you are taking mycophenolate, it is recommended you should not be immunised with ‘live’ vaccines such as MMR (measles, mumps and rubella), OPV (oral polio vaccine), BCG (Bacillus Calmette Guerin) or yellow fever. Talk to your doctor before receiving any vaccines.
• You should receive the annual influenza and COVID-19 vaccines.

Use with alcohol

• It is not exactly known how much alcohol is safe when on mycophenolate, but 1 to 2 standard drinks taken once or twice a week is unlikely to cause problems.
• Drinking more than 4 standard drinks at once, even if not often, is strongly discouraged.

Surgery

• It is not clear whether continuing during surgery changes wound healing or increases infection. Notify your doctor before planning any surgery.

Use in pregnancy and breastfeeding

• Mycophenolate should not be taken during pregnancy as it can cause miscarriage or foetal deformity.
• If you are pregnant or are considering having a child, you should discuss this with your doctor before starting this medicine.
  Your doctor may want to perform a urine pregnancy test (if you are of childbearing age) before starting mycophenolate to make sure you’re not pregnant.
• Use an effective form of birth control while taking this medicine and for up to six weeks after you stop mycophenolate.
• Mycophenolate may reduce the blood levels of some oral contraceptives. It is not known if this makes them less effective, but other forms of birth control are recommended while taking mycophenolate.
• Do not breastfeed while taking mycophenolate because the drug may be passed into the breast milk.

Contraception in men taking mycophenolate.

• There is no clear evidence that taking mycophenolate increases the risk of birth defects or miscarriage if the father is on the medication. However, the risk can’t be ruled out completely. It’s important to talk to your doctor before trying to have a baby.

Skin cancer prevention

• When taking mycophenolate, it is important to use sunscreen and avoid long sun exposure. A yearly skin check is recommended.

How to store mycophenolate

• Store mycophenolate tablets/capsules at room temperature, away from heat, moisture and light (e.g. not in the bathroom).
• Keep all medicines out of reach of children.

Important things to remember

• While taking mycophenolate you should see your rheumatologist or other specialist regularly to make sure the treatment is working and to minimise any possible side effects.
• You should have regular blood tests as directed by your specialist.
• If you are worried about any side effects, you should contact your specialist as soon as possible.

For more information see the Mycophenolate – printable information sheet.

This Information Sheet has been prepared using materials obtained from various sources which have been reviewed by the Australian Rheumatology Association (ARA). It contains general information only and does not contain a complete or definitive statement of all possible uses, actions, precautions, side effects or interactions of the medicines referenced. This information is not intended as medical advice for individual conditions nor for making an individual assessment of the risks and benefits of taking a particular medicine. Decisions regarding the assessment and treatment of patients are the sole responsibility of the treating medical professional, exercising their own clinical judgment and taking into account all of the circumstances and the medical history of the individual patient.
ARA has used all reasonable endeavours to ensure the information on which this Information Sheet is based is accurate and up to date. However, the ARA accepts no responsibility or liability for the accuracy, currency, reliability and/or completeness of the information contained in this Information Sheet. To the maximum extent permitted by law, the ARA expressly disclaims any liability for any injury, loss, harm or damage arising from or in connection with use of and reliance on the information contained in this Information Sheet. This information sheet is copyright and may be reproduced in its entirety but may not be altered without prior written permission from the ARA.
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