Mycophenolate (Myfortic)

How does it work?

Myfortic tablets contain the active ingredient mycophenolate sodium, which is a type of medicine called an immunosuppressant. These medicines reduce the body's immune response. Mycophenolate is broken down in the body to the active medicine called mycophenolic acid.

The immune system normally protects the body from foreign cells and infections by producing antibodies to fight them. A transplanted organ can be attacked by the immune system, as it is recognised by the body as a foreign substance. This is known as "transplant rejection".

Mycophenolate works by blocking the action of a compound called inosine monophosphate dehydrogenase, which is required for producing certain blood cells called T- and B-lymphocytes. These are immune cells that are responsible for regulating and triggering immune responses and thereby providing a defence against infection and foreign cells in the body.

By reducing the production of these cells, mycophenolate makes the body less likely to reject foreign material such as transplanted organs.

Mycophenolate is used together with other immunosuppressive medicines (ciclosporin and corticosteroids) as part of the transplant regimen to prevent rejection of heart, kidney and liver transplants. However, Myfortic tablets are only licensed for kidney transplants.

What is it used for?

  • Preventing the body rejecting a transplanted kidney (in combination with ciclosporin and corticosteroids).

Warning!

  • Myfortic tablets should be swallowed whole and not broken or crushed. If a tablet has been accidentally broken or crushed, avoid touching or inhaling the powder. If any powder gets on your skin, was the skin thoroughly with soap and water. If powder gets in your eyes, rinse the eyes immediately with plain water.
  • This medicine may rarely cause a decrease in the normal amounts of blood cells in the blood. For this reason you will need to have regular blood tests to monitor the levels of your blood cells. This should be weekly for the first month, twice a month for the 2nd and 3rd months and then monthly through the first year of treatment. If your white blood cell count falls below a certain level during treatment, your doctor may ask you to stop taking this medicine. You should consult your doctor immediately if you experience any of the following symptoms during treatment, as they may be signs of a problem with your blood cells: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness.
  • People having long-term or intensive immunosuppressive treatment are at increased risk of developing lymphomas and other cancers, particularly skin cancer. Therefore, to reduce the risk of skin cancer, you should minimise your exposure to strong sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor. Discuss this with your doctor.
  • Women who could get pregnant should use an effective method of contraception to prevent pregnancy during treatment with this medicine, because it may be harmful to a developing baby. Contraception should be continued for at least six weeks after stopping treatment. Consult your doctor immediately if you think you could be pregnant.

Use with caution in

  • Serious digestive system disease that is currently active.
  • Rare hereditary diseases where there is a deficiency of an enzyme called HGPRT, eg Lesch-Nyhan or Keelley-Seegmiller syndrome.

Not to be used in

  • Allergy to mycophenolate sodium, mycophenolate mofetil or mycophenolic acid.
  • Breastfeeding.
  • Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Myfortic tablets contain lactose).

This medicine should not be used if you are allergic to one or 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 may be harmful to a developing baby and for this reason, it is recommended that a pregnancy test is performed before treatment is started.
  • This medicine is not recommended for use in women who are pregnant, unless considered essential by your doctor because there is no suitable alternative treatment available. Seek medical advice from your doctor.
  • Women who could get pregnant should use an effective method of contraception to prevent pregnancy during treatment with this medicine. Contraception should be continued for at least six weeks after stopping treatment. You should consult your doctor immediately if you think you could be pregnant.
  • It is not known if this medicine passes into breast milk. However, because it could be harmful to a nursing infant if it does pass into the milk, it should not be used during breastfeeding. Mothers who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Label warnings

  • This medication should be swallowed whole, not broken, chewed or crushed.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
  • Decrease in the number of white blood cells, platelets or red blood cells in the blood (leucopenia, thrombocytopenia or anaemia)
  • Increased susceptibility to infections.
  • Disturbances in the levels of chemical components (electrolytes) in the blood.
  • Ulceration or bleeding in the stomach or intestines.
  • Headache.
  • Depression, anxiety.
  • Confusion.
  • Seizures (convulsions).
  • Dizziness.
  • Tremor, pins and needles sensations (paraesthesia).
  • Difficulty sleeping (insomnia).
  • Alteration in taste, loss of appetite.
  • Cough, shortness of breath (dyspnoea).
  • Cold or flu-like symptoms.
  • Excessive fluid retention in the body tissues, resulting in swelling (oedema).
  • Inflammation of the liver (hepatitis), jaundice.
  • Changes in blood pressure, increased heart rate.
  • Rash, acne, hair loss.
  • Increased risk of developing lymphomas and other cancers, particularly skin cancer (see warning above).

The side effects listed above may not include all of the side effects reported by the drug'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 while taking this one, to ensure that the combination is safe.

The manufacturer of this medicine recommends that it should not be used in combination with azathioprine, as they have not studied the effect of this combination.

The body's response to vaccination is reduced by medicines such as mycophenolate, which suppress the immune system and prevent the body forming adequate antibodies. Therefore, vaccines may less effective in people taking this medicine. Live vaccines may cause infection in people taking this medicine and these should therefore be avoided. Live vaccines include the following: oral polio; rubella; measles, mumps and rubella (MMR); BCG; yellow fever and oral typhoid vaccines.

The following medicines reduce the absorption of mycophenolate from the gut and may therefore reduce the amount in the blood. As this could make it less effective, these medicines should not be taken within two to three hours of taking mycophenolate (ask your pharmacist for more advice):

  • antacids (indigestion remedies)
  • colestyramine
  • iron tablets or liquids
  • sevelamer.

The following medicines may also decrease the amount of this medicine in the blood:

  • ciclosporin
  • norfloxacin and metronidazole used together
  • rifampicin.

If people with decreased kidney function take any of the following medicines in combination with mycophenolate, the blood levels of both medicines may be higher than normal and as a result they should be closely monitored:

  • aciclovir
  • ganciclovir
  • valaciclovir
  • valganciclovir.

Other medicines containing the same active ingredient

CellCept contains mycophenolate mofetil. However, Cellcept and Myfortic are not interchangeable. because the body handles these different brands of mycophenolate in slightly different ways. Switching between the two should be avoided.