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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


Mycophenolate mofetil — codes and concepts
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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

Precautions

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.

New Zealand approved datasheets are the official source of information for prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website.

If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).

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Related information

 

Bibliography

  • Kitchin JE, Pomeranz MK, Pak G, Washenik K, Shupack JL. Rediscovering mycophenolic acid: a review of its mechanism, side effects, and potential uses. J Am Acad Dermatol. 1997;37(3 Pt 1):445–9. doi:10.1016/s0190-9622(97)70147-6. PubMed
  • Mydlarski PR. Mycophenolate mofetil: a dermatologic perspective. Skin Therapy Lett. 2005;10(3):1–6. Journal
  • Orvis AK, Wesson SK, Breza TS Jr, Church AA, Mitchell CL, Watkins SW. Mycophenolate mofetil in dermatology. J Am Acad Dermatol. 2009;60(2):183–202. doi:10.1016/j.jaad.2008.08.049. PubMed
  • Park H. The emergence of mycophenolate mofetil in dermatology: from its roots in the world of organ transplantation to its versatile role in the dermatology treatment room. J Clin Aesthet Dermatol. 2011;4(1):18–27. PubMed Central
  • Phan K, Smith SD. Mycophenolate mofetil and atopic dermatitis: systematic review and meta-analysis. J Dermatolog Treat. 2020;31(8):810–14. doi:10.1080/09546634.2019.1642996. PubMed
  • Sharma P, Guragain A, Adhikari S, Dahal S, Dhungana B. Acute mycophenolate mofetil overdose managed conservatively. Cureus. 2021;13(8):e17417. doi:10.7759/cureus.17417. PubMed Central
  • Strathie Page SJ, Tait CP. Mycophenolic acid in dermatology a century after its discovery. Australas J Dermatol. 2015;56(1):77-83. doi:10.1111/ajd.12259. PubMed
  • Yamauchi PS, Rizk D, Kormeili T, Patnaik R, Lowe NJ. Current systemic therapies for psoriasis: where are we now?. J Am Acad Dermatol. 2003;49(2 Suppl):S66-S77. doi:10.1016/mjd.2003.550. PubMed

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