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Mycophenolic acid oral


Oral formulations of mycophenolic acid (as mycophenolate sodium).

Drugs List

  • CEPTAVA 180mg gastro-resistant tablets
  • CEPTAVA 360mg gastro-resistant tablets
  • mycophenolic acid 180mg gastro-resistant tablets
  • mycophenolic acid 360mg gastro-resistant tablets
  • MYFORTIC 180mg tablets
  • MYFORTIC 360mg tablets
  • Therapeutic Indications


    Prophylaxis of acute organ rejection for allogeneic renal transplant

    Prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants in combination with ciclosporin and corticosteroids.


    Whilst the doses stated below are those recommended by the manufacturers, local protocols for the relevant indication should be consulted.

    Mycophenolic acid and mycophenolate mofetil should not be indiscriminately interchanged or substituted due to their different pharmacokinetic profiles.

    The medication can be taken with or without food - the patient must chose the option and it should be adhered to.


    The recommended dose is 720mg twice daily. (Total daily dose 1440mg, equivalent to 2g total daily dose of mycophenolate mofetil)

    In de novo patients treatment should be initiated within 72 hours following transplant.


    Children under 18 years

    Precautions and Warnings

    Hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase
    Drug induced neutropenia with cell count below 1.5 x 10 to the power of 9/L
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Renal impairment- creatinine clearance below 25ml/minute/1.73 square metre
    Severe gastrointestinal disorder

    Administration of live vaccines is not recommended
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Exclude pregnancy prior to initiation of treatment
    Consider immunosuppressant adjustment in the event of PML
    If dyspnoea occurs, investigate for signs of progressive pulmonary disorder
    Monitor FBC monthly from 4th month for the 1st year of treatment
    Monitor FBC weekly for 1st month then fortnightly for 2nd and 3rd month
    Monitor for and manage hepatitis reactivation during treatment
    Monitor for signs of bone marrow depression
    Monitor renal function in patients with renal impairment
    Monitor serum immunoglobulins in patients with recurrent infections
    Advise patient to report persistent cough
    Advise patient to report symptoms of infection immediately
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Consider immunosuppressant adjustment if BK virus nephropathy develops
    If pure red cell aplasia is diagnosed reduce dose or discontinue treatment
    Immunosuppressive drugs may increase risk of malignancy
    May reduce effectiveness of vaccinations during treatment
    Oversuppression of immune system may increase susceptibility to infection
    Advise patient to seek advice at first indications of pregnancy
    Discontinue or interrupt treatment if neutropenia develops
    Female: Contraception required before, during & for 6 weeks after treatment
    Female: Two reliable methods of contraception should be used simultaneously
    Male: Use barrier contraception during and for 3 months after treatment
    Advise patient to avoid exposure to sunlight and UV rays during treatment
    Male: Contraception required for partners for 3 months after treatment
    Patients should not donate blood during or for 6 weeks after treatment
    Patients should not donate semen during or for 3 months after treatment

    Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressants. Although the mechanism is unknown mycophenolate mofetil induced PRCA may resolve with dose reduction or cessation of therapy. However changes to therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimise the risk of graft rejection.

    Cases of hypogammaglobulinaemia have been reported in association with recurrent infections. Patients with recurrent infections should have their immunoglobulins measured and patients with sustained hypogammaglobulinaemia should be treated appropriately considering the potent cytostatic effects of mycophenolic acid on T and B lymphocytes.

    Cases of bronchiectasis have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressants. The risk may be linked to hypogammaglobulinaemia or direct effects on the lungs. Patients with persistent pulmonary symptoms such as cough and dyspnoea should be investigated for progressive pulmonary disorders.

    Prior to initiation female patients of child bearing potential are recommended to have pregnancy excluded using two serum or urine pregnancy tests with a sensitivity of at least 25 mIU/ml. The second test should be preformed 8-10 days after the first and be immediately prior to initiation of mycophenolic acid.

    Consider therapeutic drug monitoring of mycophenolate levels when starting or stopping concomitant ciclosporin.

    Progressive Multifocal Leukoencephalopathy Syndrome (PML)
    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed immunosuppressant treatment should be permanently discontinued.

    Pregnancy and Lactation


    Mycophenolic acid is contraindicated in pregnancy.

    Use in the first trimester is associated with spontaneous abortions and major birth defects. Malformations include external ear, facial anomalies and defects in the heart, oesophagus and kidney.

    Animal studies have shown reproductive toxicity.

    Schafer concludes that the use of the drug in pregnancy does not require termination of pregnancy. A detailed ultrasound should be offered to confirm normal morphological development in cases of first trimester exposure.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Mycophenolic acid is contraindicated in breastfeeding.

    It is not known whether mycophenolic acid is excreted in human milk although its presence has been shown in the milk of lactating rats. The molecular weight is low enough that it is likely to be present in human breast milk. A risk to neonates cannot be excluded.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal distension
    Altered liver function tests
    Back pain
    BK virus associated with nephropathy
    Blood pressure changes
    Blurred vision
    Cytomegalovirus gastritis
    Diabetes mellitus
    Dream abnormalities
    Dry mouth
    Duodenal ulcer
    Electrolyte disturbances
    Gastric ulceration
    Gastro-intestinal disturbances
    Gastro-intestinal haemorrhage
    Gastro-intestinal perforation
    Gastroesophageal reflux disease
    Gingival hyperplasia
    Increased risk of skin cancer
    Influenza-like syndrome
    Interstitial lung disease
    Kaposi's Sarcoma
    Lip ulceration
    Lymphoproliferative disorders
    Muscle cramps
    Mycobacterial infection
    Opportunistic infections
    Parotid duct obstruction
    Peptic ulceration
    Progressive multifocal leukoencephalopathy (PML)
    Pulmonary congestion
    Pulmonary fibrosis
    Pulmonary oedema
    Red cell aplasia
    Renal tubular necrosis
    Serum creatinine increased
    Skin papilloma
    Soft or liquid stools
    Tongue discolouration (reversible)
    Urethral stricture


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2018

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    MHRA Drug Safety Update November 2015
    Available at:
    Last accessed: 14 March 2018

    Summary of Product Characteristics: Ceptava 180mg Gastro-resistant Tablets. Sandoz Limited. Revised May 2018.

    Summary of Product Characteristics: Ceptava 360mg Gastro-resistant Tablets. Sandoz Limited. Revised May 2018.

    Summary of Product Characteristics: Myfortic 180mg gastro-resistant tablets. Novartis Pharmaceuticals UK. Revised August 2018.

    Summary of Product Characteristics: Myfortic 360mg gastro-resistant tablets. Novartis Pharmaceuticals UK. Revised August 2018.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

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