Formulary
Mycophenolate mofetil: Indications, Dosing, Side Effects and Interactions
Mycophenolate mofetil clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Mycophenolate mofetil: Indications, Dosing, Side Effects and Interactions
Mycophenolate mofetil clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Prophylaxis of acute rejection in renal transplantation (in combination with a corticosteroid and ciclosporin) (under expert supervision)**
- **Adult** (By Mouth): 1 g twice daily, to be started within 72 hours of transplantation.
- **Adult** (By Intravenous Infusion): 1 g twice daily for maximum 14 days, then transfer to oral therapy, to be started within 24 hours of transplantation.
**Prophylaxis of acute rejection in cardiac transplantation (in combination with ciclosporin and corticosteroids) (under expert supervision)**
- **Adult** (By Mouth): 1.5 g twice daily, to be started within 5 days of transplantation.
**Renal transplantation (specialist use only)**
- **Adult** (By Mouth): 720 mg twice daily, to be started within 72 hours of transplantation.
**Prophylaxis of acute rejection in renal transplantation (in combination with a corticosteroid and ciclosporin) (under expert supervision) for mycophenolate mofetil**
- **Child** (By mouth): 600 mg/m2 twice daily, consult local protocol for details; maximum 2 g per day.
**Prophylaxis of acute rejection in renal transplantation (in combination with a corticosteroid and tacrolimus) (under expert supervision) for mycophenolate mofetil**
- **Child** (By mouth): 300 mg/m2 twice daily, consult local protocol for details; maximum 2 g per day.
**Prophylaxis of acute rejection in hepatic transplantation (in combination with a corticosteroid and ciclosporin or tacrolimus) (under expert supervision) for mycophenolate mofetil**
- **Child** (By mouth): 10 mg/kg twice daily, increased to 20 mg/kg twice daily, consult local protocol for details; maximum 2 g per day.
Cautions
Active serious gastro-intestinal disease (risk of haemorrhage, ulceration and perforation); children (higher incidence of side-effects may call for temporary reduction of dose or interruption); delayed graft function; elderly (increased risk of infection, gastro-intestinal haemorrhage and pulmonary oedema); increased susceptibility to skin cancer (avoid exposure to strong sunlight); risk of hypogammaglobulinaemia or bronchiectasis when used in combination with other immunosuppressants Cautions, further information Hypogammaglobulinaemia or bronchiectasis Measure serum immunoglobulin levels if recurrent infections develop, and consider bronchiectasis or pulmonary fibrosis if persistent respiratory symptoms such as cough and dyspnoea develop.
Side effects
General side-effects: Common or very common Acidosis; alopecia; anaemia; appetite decreased; arthralgia; asthenia; bone marrow disorders; chills; constipation; cough; depression; diarrhoea; drowsiness; dyslipidaemia; dyspnoea; electrolyte imbalance; fever; gastrointestinal discomfort; gastrointestinal disorders; gastrointestinal haemorrhage; headache; hyperglycaemia; hypertension; hypotension; increased risk of infection; insomnia; leucocytosis; leucopenia; malaise; nausea; neoplasms; oedema; oral disorders; pain; pancreatitis; paraesthesia; renal impairment; respiratory disorders; seizure; sepsis; skin reactions; tachycardia; thinking abnormal; thrombocytopenia; tremor; vomiting; weight decreased Uncommon Agranulocytosis Frequency not known Endocarditis; hypogammaglobulinaemia; interstitial lung disease; malignancy; meningitis; neutropenia; polyomavirus-associated nephropathy; progressive multifocal leukoencephalopathy (PML); pulmonary fibrosis; pure red cell aplasia Specific side-effects: Common or very common With intravenous use Hepatitis; muscle tone increased With oral use Anxiety; burping; confusion; dizziness; gout; hepatic disorders; hyperbilirubinaemia; hyperuricaemia; neuromuscular dysfunction; taste altered; vasodilation Side-effects, further information Cases of pure red cell aplasia have been reported with mycophenolate mofetil; dose reduction or discontinuation should be considered under specialist supervision.
Interactions
**Severe interactions:**
- Norfloxacin and metronidazole In healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately.
- Tacrolimus In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and C max of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected...
**Other interactions (25):**
- Aciclovir Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
- Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs,...
- Antacids and proton pump inhibitors (PPIs) Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were...
- Medicinal products that interfere with enterohepatic recirculation (e.g.
- Cholestyramine Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in...
- Ciclosporin A Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Pregnancy
Conception and contraception For mycophenolate mofetil Pregnancy prevention The MHRA advises to exclude pregnancy in females of child-bearing potential before treatment-2 pregnancy tests 8-10 days apart are recommended. Women should use at least 1 method of effective contraception before and during treatment, and for 6 weeks after discontinuation-2 methods of effective contraception are preferred. Male patients or their female partner should use effective contraception during treatment and for 90 days after discontinuation.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Renal impairment
No data available in cardiac or hepatic transplant patients with renal impairment.
Medicinal forms
Suspension,Tablet,Tablet,Capsule,Suspension,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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