Intravenous Prophylaxis of acute graft rejection in renal transplantation
Adult: In combination with other immunosuppressants for patients who are unable to take oral doses: As mycophenolate mofetil: 1 g bid via IV infusion over 2 hours, to be started within 24 hours of transplantation. Max treatment duration: 14 days. Switch to oral doses as soon as tolerated. Dose reduction, dosing interruption or discontinuation may be required according to individual safety (refer to detailed product guidelines).
Intravenous Prophylaxis of rejection in cardiac graft transplant
Adult: In combination with other immunosuppressants for patients who are unable to take oral doses: As mycophenolate mofetil: 1.5 g bid via IV infusion over 2 hours, to be started within 24 hours of transplantation. Max treatment duration: 14 days. Switch to oral doses as soon as tolerated. Dose reduction, dosing interruption or discontinuation may be required according to individual safety (refer to detailed product guidelines).
Intravenous Prophylaxis of rejection in liver graft transplant
Adult: In combination with other immunosuppressants: As mycophenolate mofetil: Initially, 1 g bid via IV infusion over 2 hours, to be started within 24 hours of transplantation and continued for the 1st 4 days after the hepatic transplant. Max treatment duration: 14 days. Switch to oral doses as soon as tolerated. Dose reduction, dosing interruption or discontinuation may be required according to individual safety (refer to detailed product guidelines).
Oral Prophylaxis of rejection in liver graft transplant
Adult: In combination with other immunosuppressants: As mycophenolate mofetil: Initiate therapy using IV doses for the 1st 4 days after hepatic transplantation up to a Max of 14 days, then switch to oral doses of 1.5 g bid as soon as tolerated. Dose reduction, dosing interruption or discontinuation may be required according to individual safety (refer to detailed product guidelines).
Oral Prophylaxis of acute graft rejection in renal transplantation
Adult: In combination with other immunosuppressants: As mycophenolate mofetil: 1 g bid started within 72 hours of transplantation. As mycophenolate sodium: Dose is expressed in terms of mycophenolic acid. Recommended dose: 720 mg bid started within 72 hours of transplantation. Dose reduction, dosing interruption or discontinuation may be required according to individual safety (refer to detailed product guidelines). Child: In combination with other immunosuppressants: As mycophenolate mofetil: ≥3 months As oral susp: 600 mg/m2 bid. Max: 2,000 mg daily. As cap or conventional tab: For patients with BSA of 1.25-1.5 m2: 750 mg bid; >1.5 m2: 1,000 mg bid. Dose reduction, dosing interruption or discontinuation may be required according to individual safety. Dosage recommendations or starting age of use may vary among individual products and between countries (refer to detailed product guidelines).
Oral Prophylaxis of rejection in cardiac graft transplant
Adult: In combination with other immunosuppressants: As mycophenolate mofetil: 1.5 g bid started within 5 days of transplantation. Dose reduction, dosing interruption or discontinuation may be required according to individual safety (refer to detailed product guidelines).
What are the brands available for Mycophenolic acid in Thailand?
Oral: Prophylaxis of acute graft rejection in renal transplantation:
GFR (mL/min/1.73 m2)
Dosage
<25
For severe chronic cases: As mycophenolate mofetil: Avoid doses of >1 g bid. As mycophenolate sodium: Dose is expressed in terms of mycophenolic acid. Limit dose to 720 mg bid.
Intravenous: Prophylaxis of acute graft rejection in renal transplantation:
GFR (mL/min/1.73 m2)
Dosage
<25
For severe chronic cases: As mycophenolate mofetil: Avoid doses of >1 g bid.
Administration
Mycophenolate mofetil Should be taken on an empty stomach. In stable renal transplant patients: may be administered w/ food. Oral susp: May be given via nasogastric tube (≥8 French size); do not mix with any other liquid. Flush feeding tube with appropriate volume of purified water after administration. Cap and conventional/enteric-coated tab: Swallow whole; do not open the cap or crush the tab.
Reconstitution
Powder for oral susp: Reconstitute with 47 mL of water, then shake well for approx 1 minute. Add another 47 mL of water and shake the closed bottle for approx 1 minute to prepare a final concentration of 200 mg/mL. Powder for solution for IV infusion: Reconstitute each 500 mg vial with 14 mL of dextrose 5% in water. Further dilute the contents of 2 reconstituted vials (for 1 g dose) with 140 mL or 3 reconstituted vials (for 1.5 g dose) with 210 mL of dextrose 5% in water to make a final concentration of 6 mg/mL. Avoid or direct contact of the powder for oral susp or prepared infusion solution with the skin or mucous membranes.
Contraindications
Hypersensitivity to mycophenolic acid, mycophenolate mofetil or mycophenolate sodium. Women of childbearing potential who are not using highly effective contraceptive methods. Lactation.
Special Precautions
Patient with active serious gastrointestinal disorders. Avoid use in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Kelley-Seegmiller or Lesch-Nyhan syndrome. Mycophenolate mofetil and mycophenolate sodium formulations are not equivalent on a mg per mg basis and should not be used interchangeably due to varying pharmacokinetic profiles. IV solution must not be administered via rapid or bolus inj. Avoid vaccination with live vaccines. Renal impairment. Children and elderly. Avoid use in pregnancy (unless no suitable alternative therapy).
Adverse Reactions
Significant: Bone marrow suppression (e.g. neutropenia, anaemia, leucopenia, thrombocytopenia, pure red cell aplasia [PRCA]), reversible acute inflammatory syndrome; gastrointestinal ulceration, perforation or haemorrhage; increased risk of developing lymphoma or other malignancies, particularly skin cancer; hypogammaglobulinaemia, bronchiectasis; phlebitis or thrombosis (particularly if given via rapid or bolus IV inj). Blood and lymphatic system disorders: Leucocytosis, pancytopenia, pseudolymphoma. Cardiac disorders: Tachycardia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, abdominal distension, constipation, colitis, dyspepsia, oesophagitis, flatulence, gastritis, mouth ulceration, stomatitis. General disorders and administration site conditions: Asthenia, malaise, chills, fever, oedema, hernia, pain. Hepatobiliary disorders: Hyperbilirubinaemia, hepatitis, jaundice. Investigations: Decreased weight; increased hepatic enzymes, serum alkaline phosphatase and LDH; increased BUN and serum creatinine. Metabolism and nutrition disorders: Acidosis, hyperglycaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hypocalcaemia, hypophosphataemia, hypercholesterolaemia, hyperlipidaemia, hyperuricaemia, gout, decreased appetite. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, muscle weakness. Nervous system disorders: Headache, dizziness, somnolence, paraesthesia, hypertonia, tremor, convulsion. Psychiatric disorders: Confusion, insomnia, depression, agitation, anxiety, abnormal thinking. Renal and urinary disorders: Haematuria, renal impairment. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, pleural effusion, pneumonia, URTI. Skin and subcutaneous tissue disorders: Rash, acne, pruritus, alopecia, ecchymosis, skin hypertrophy. Vascular disorders: Hypertension, hypotension, venous thrombosis, vasodilatation. Potentially Fatal: Hypersensitivity reactions (e.g. anaphylaxis, angioedema); bacterial, viral, fungal, or protozoal infections, including sepsis, reactivation of HBV or HCV, polyomavirus-associated nephropathy (particularly due to BK virus infection), CMV infection, COVID-19, and John Cunningham (JC) virus-associated progressive multifocal leucoencephalopathy (PML). Rarely, ILD and pulmonary fibrosis.
This drug may cause dizziness or drowsiness, if affected, do not drive or operate machinery. Avoid prolonged exposure to sunlight and UV light; use a sunscreen with high protection factor or wear protective clothing when going outdoors. Do not donate blood during treatment and for at least 6 weeks after treatment discontinuation. Do not open the cap or crush the tab to avoid inhaling the powder or having direct contact with the skin. Women of childbearing potential must use proven birth control methods (preferably 2 methods) before initiation, during therapy and for 6 weeks after stopping the treatment. Men and/or their female partners of childbearing potential must use effective birth control methods during treatment and for at least 90 days after stopping the treatment. Men should not donate semen during therapy and for 90 days after the last dose.
Monitoring Parameters
Perform pregnancy test (with sensitivity of ≥25 milliunits/mL) in women of childbearing potential before treatment initiation and 8-10 days later, then repeat the tests during treatment as clinically required. Monitor CBC (weekly during the 1st month, twice a month during the 2nd and 3rd months, then monthly thereafter throughout the 1st year); liver and renal function. Assess for signs and symptoms of anaphylactic reactions, organ rejection, infection (including new or reactivated viral infections), neurological effects suggestive of PML, acute inflammatory syndrome, lymphoma, skin lesions (suspicious of skin cancer), and bone marrow suppression (e.g. neutropenia, anaemia, PRCA).
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, oversuppression of the immune system, increased susceptibility to infection, and bone marrow suppression (e.g. neutropenia, leucopenia). Management: Symptomatic and supportive treatment. May administer bile acid sequestrants (e.g. colestyramine) to reduce MPA exposure.
Drug Interactions
May decrease the efficacy of live vaccines. May increase the plasma concentrations of aciclovir, valaciclovir, ganciclovir, and valganciclovir. Mycophenolic acid (MPA) exposure and efficacy may be reduced when given with telmisartan, sevelamer, antacids (e.g. magnesium hydroxide, aluminium hydroxide), PPIs (e.g. pantoprazole, lansoprazole), and drugs that interfere directly or indirectly with MPA enterohepatic recirculation (e.g. ciclosporin, colestyramine, rifampicin, aminoglycosides, penicillins, cephalosporins, fluoroquinolones). Increased MPA exposure with isavuconazole.
Food Interaction
Food may reduce the MPA maximal concentration; however, the extent of absorption is unchanged.
Action
Description: Mechanism of Action: Mycophenolic acid (MPA), an immunosuppressant, is a selective, reversible, and uncompetitive inhibitor of inosine monophosphate dehydrogenase (IMPDH) that blocks the de novo guanosine nucleotide synthesis without incorporation into DNA. Due to this activity, it has potent cytostatic effects on T- and B-lymphocytes. Additionally, MPA alters the cellular checkpoints for lymphocyte metabolic programming by shifting the transcriptional lymphocyte activity from a proliferative state to catabolic processes. Pharmacokinetics: Absorption: Mycophenolate mofetil is rapidly and extensively absorbed from the gastrointestinal tract; mycophenolate sodium is also extensively absorbed after oral administration. Food may reduce the MPA maximal concentration by 40% and 33% following mycophenolate mofetil and mycophenolate sodium administration, respectively; however, the extent of absorption is unchanged. Bioavailability: Oral: 94% (mycophenolate mofetil); 72% (mycophenolate sodium). Time to peak plasma concentration: Mycophenolate sodium: 1.5-2 hours (MPA). Distribution: Volume of distribution: Mycophenolate mofetil: Approx 3.6 ± 1.5 L/kg (MPA). Plasma protein binding: 97% (MPA); 82% (mycophenolic acid glucuronide [MPAG]). Metabolism: Mycophenolate mofetil is completely hydrolysed in the liver to form MPA (active metabolite), which undergoes enterohepatic recirculation. MPA is converted in the liver and gastrointestinal tract by glucuronyl transferase into the inactive MPAG. Excretion: Mycophenolate mofetil: Via urine (87% as MPAG; <1% as MPA); faeces (6%). Elimination half-life: Oral: 17.9 ± 6.5 hours (MPA); 16.6 ± 5.8 hours (IV). Mycophenolate sodium: Via urine (>60% as MPAG; approx 3% as MPA); faeces (as MPA). Elimination half-life: 8-16 hours (MPA); 13-17 hours (MPAG).
Chemical Structure
Mycophenolic acid Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 446541, Mycophenolic Acid. https://pubchem.ncbi.nlm.nih.gov/compound/Mycophenolic-Acid. Accessed Aug. 26, 2025.
Storage
Cap: Store at or below 25°C. Conventional or enteric-coated tab/Oral susp/Intact vial: Store below 30°C. Protect the conventional or enteric-coated tab from moisture. Reconstituted oral susp: May be stored between 15-30°C or between 2-8°C for up to 60 days. Do not freeze. Reconstituted and diluted solution for IV infusion: Store between 15-30°C. Infuse the solution within 3 or 4 hours from reconstitution and dilution. Follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary between products. Refer to detailed product guidelines.
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Brayfield A, Cadart C (eds). Mycophenolate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/08/2025.CellCept 250 mg Hard Capsules, 500 mg Powder for Concentrate for Solution for Infusion, 1 g/5 mL Powder for Oral Suspension and 500 mg Film-coated Tablets (Roche Registration GmbH). European Medicines Agency [online]. Accessed 06/08/2025.CellCept Capsule and Tablet (Roche [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/08/2025.CellCept Film Coated Tablet, Capsule, Lyophilized Powder for Solution Injection and Powder for Suspension (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/08/2025.Ceptava 180 mg Gastro-resistant Tablets (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/08/2025.Joint Formulary Committee. Mycophenolate Mofetil. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/08/2025.Mycophenolate. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/08/2025.Mycophenolic Acid [Mycophenolate]. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/08/2025.Myfortic Gastro-resistant Tablets (Novartis Corporation [M] Sdn. Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/08/2025.Myfortic Tablet, Delayed Release (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/08/2025.Roche Products (New Zealand) Limited. CellCept 250 mg Hard Capsules, 500 mg Film-coated Tablets, 500 mg Powder for Infusion and 200 mg/mL Powder for Oral Suspension data sheet 06 August 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 06/08/2025.
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