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Mycophenolate mofetil

Authors: Vanessa Ngan, Staff Writer, 2003. Updated: Dr Kelvin Truong, Dermatology Research Fellow, Westmead Hospital, Sydney, Australia. Copy edited by Gus Mitchell. October 2021


What is mycophenolate mofetil?

Mycophenolate mofetil is the prodrug form of mycophenolic acid, a potent immunosuppressive drug. Enteric-coated mycophenolate sodium is another form of mycophenolic acid used in clinical practice.

Who uses mycophenolate mofetil?

Mycophenolate mofetil is an immunosuppressant approved for to prevent rejection of solid organ (kidney, liver, heart) transplants. 

Off-label use of mycophenolate mofetil is widespread in dermatology.

Immunobullous diseases that may be treated with mycophenolate mofetil

What are the contraindications and precautions with mycophenolate mofetil?

Absolute contraindications

  • Allergy to the drug or its excipients
  • Pregnancy
    • Reported to cause spontaneous abortion, craniofacial malformations, cardiac malformations
    • Women must use effective contraception starting four weeks before commencement, throughout treatment, and for six weeks after the last dose
    • Men should use condoms during sexual intercourse throughout treatment and for 90 days after the last dose. Female partners of males treated with mycophenolate mofetil should also use effective contraception during their partner’s treatment and for 90 days after the partner’s last treatment dose.

Relative contraindications

  • Lactation
  • Peptic ulcer disease
  • Liver disease
  • Cardiopulmonary disease


Tell me more about mycophenolate mofetil

Mechanism of action

  • Reversible, selective, non-competitive inhibitor of the enzyme inosine monophosphate dehydrogenase (IMPDH)
  • IMPDH is an important enzyme in the synthesis of purines
    • Purine synthesis is essential for lymphocyte development and proliferation
  • Blocking IMPDH inhibits T- and B-lymphocyte function
    • Reduces lymphocyte proliferation, antibody formation, and cell-mediated immune response

Drug forms and dosing

Mycophenolate mofetil is available in oral and intravenous formulations.

A typical starting dose used in dermatology is 250 mg twice daily. If no improvement is observed after one month of therapy, the dose may be increased by 500 milligram increments up to a maximum of 3 g per day.

Dose reduction is required with chronic renal insufficiency as mycophenolic acid is mostly excreted via the kidneys.

Mycophenolate mofetil is often used in combination with other immunosuppressive drugs [see Drug-induced immunosuppression]

What are the benefits of mycophenolate mofetil?

  • Well-tolerated
  • Oral administration available
  • Wide therapeutic range

What are the disadvantages of mycophenolate mofetil?

  • Clinical response is slow
  • Regular blood test monitoring is required
  • Contraception is necessary for both males and females taking mycophenolate mofetil
  • Drug interactions
    • Reduced mycophenolate blood level
    • Increased mycophenolate blood level
      • Probenecid
      • Salicylates, phenytoin
    • Mycophenolate may increase the blood level of other drugs

What are the side effects and risks of mycophenolate mofetil?

Side effects

Mucocutaneous side effects 

Mycophenolate mofetil can increase the risk of these skin infections

Common side effects

  • Nausea and vomiting, diarrhoea or constipation, abdominal cramps.
  • Infections
    • Bacterial — urinary tract infection, pneumonia
    • Viral — cytomegalovirus (CMV), BK virus.

Uncommon but potentially serious side effects

Monitoring during treatment

Before starting treatment

During treatment

  • Regular full blood count – weekly for the first month then every two weeks for two months, and monthly for the rest of the first year
  • Liver and kidney function tests — every 2–4 weeks until dose is stabilised and then every 2–3 months
  • Pregnancy test if appropriate in the first week
  • Regular skin checks — patient should practice self skin examination

Discontinuation of treatment

Mycophenolate mofetil should be ceased if pregnancy occurs or:

  • Lymphocyte count < 1.0x109/L
  • Anaemia
  • Thrombocytopenia

Bone marrow suppression, if mild, usually recovers with dose reduction or cessation of the mycophenolate mofetil.

Approved datasheets are the official source of information for medicines, including approved uses, doses, and safety information. Check the individual datasheet in your country for information about medicines.

We suggest you refer to your national drug approval agency such as the Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration (FDA)UK Medicines and Healthcare products regulatory agency (MHRA) / emc, and NZ Medsafe, or a national or state-approved formulary eg, the New Zealand Formulary (NZF) and New Zealand Formulary for Children (NZFC) and the British National Formulary (BNF) and British National Formulary for Children (BNFC).



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