Mycophenolic acid 360mg gastro-resistant tablets
Requires a prescription from a doctor or prescriber
Mycophenolic acid is a potent immunosuppressant agent that inhibits <em>de novo</em> purine biosynthesis.[L42165] It was derived from <em>Penicillium stoloniferum</em>, and has also shown antibacterial, antifungal and antiviral properties.[A249170].
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Suspected adverse reactions reported for Mycophenolic acid
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Suspected adverse reactions reported for Mycophenolic acid
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4 branded products available
MHRA licensed products
View all licensed products for Mycophenolic acid on the MHRA register
Ceptava 360mg gastro-resistant tablets
Myfortic 360mg gastro-resistant tablets
Mycophenolic acid 360mg gastro-resistant tablets
Mycophenolic acid 360mg gastro-resistant tablets
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
2 gram
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(3)
Immunosuppressive therapy for kidney transplant in adults (TA481)
Immunosuppressive therapy for kidney transplant in children and young people (TA482)
Prevention of recurrence of C3 glomerulopathy post-transplant: eculizumab (ESUOM44)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Codes for healthcare professionals and prescribing systems
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NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing all 27 studies.
Reviews & meta-analyses: 7 · 2017–2026
Showing all 27 studies, sorted by most relevant.
A. Leino, John Takyi-Williams, M. Pai
Therapeutic Drug Monitoring, 2023
- Organ Transplantation
- Tacrolimus
- Blood Specimen Collection
Pannaphak Hirunsatitpron, Nutthiya Hanprasertpong, K. Noppakun, et al.
British Journal of Clinical Pharmacology, 2021
- Neoplasms
- Organ Transplantation
- Azathioprine
Tony K. L. Kiang, M. H. Ensom
Clinical Pharmacokinetics, 2018
- Autoimmune Diseases
- Immunosuppressive Agents
- Mycophenolic Acid
Juthipong Benjanuwattra, P. Chaiyawat, Dumnoensun Pruksakorn, et al.
European journal of pharmacology, 2020
- Antibiotics, Antineoplastic
- IMP Dehydrogenase
- Mycophenolic Acid
Yan Rong, Heajin Jun, Tony K. L. Kiang
British Journal of Clinical Pharmacology, 2020
- Mycophenolic Acid
- Kidney Transplantation
- Bayes Theorem
Tony K. L. Kiang, M. H. Ensom
Clinical Pharmacokinetics, 2019
- Graft Rejection
- Immunosuppressive Agents
- Mycophenolic Acid
Tom C. Zwart, Sumit R M Gokoel, P. V. D. van der Boog, et al.
British Journal of Clinical Pharmacology, 2018
- Kidney Transplantation
- Mycophenolic Acid
- Tacrolimus
F. D. Genvigir, Álvaro Cerda, T. D. C. Hirata, et al.
2020
Mycophenolic acid (MPA) is a potent antiproliferative drug prescribed to prevent acute rejection in kidney transplantation. MPA reversibly inhibits the enzymes involved in the synthesis of guanosine nucleotides, thus preventing DNA replication of immune cells. Consequently, the repression of both cell and humoral immunity induces renal allograft tolerance. MPA is an effective and safe immunosuppressive drug, but some patients show variability in drug concentration, acute rejection, graft dysfunction, or MPA-related adverse events. Although the pharmacogenomics of immunosuppressive drugs has been widely investigated, MPA has been explored to a lesser extent. This review of MPA pharmacogenomic studies, included pharmacokinetics, adverse events, and main clinical outcomes of MPA treatment in kidney transplantation. Associations of variants in genes encoding MPA metabolizing enzymes, transporters, and targets with drug efficacy and safety are described. Most pharmacogenetic studies have focused on small sample sizes and few simultaneously analyzed genetic variants. Some studies reported significant associations of pharmacokinetics-and pharmacodynamics-related genes with MPA exposure, acute rejection, graft dysfunction, hematological events, and gastrointestinal complications. However, even large cohorts did not replicate the findings, possibly due to divergent study design, immunosuppressive scheme, follow-up time, and other factors. Finally, the heterogeneity of aspects between studies limit conclusions on pharmacogenetic biomarkers of MPA in kidney transplantation.
Abstract licence: CC BY
Fumihiro Kato, S. Matsuyama, Miyuki Kawase, et al.
Microbiology and Immunology, 2020
- Betacoronavirus
- COVID-19
- SARS-CoV-2
Wei Zhang, L. Du, Z. Qu, et al.
Proceedings of the National Academy of Sciences, 2019
- Aspergillus oryzae
- Endoplasmic Reticulum
- Golgi Apparatus
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
16 hours
Mechanism
Mycophenolic acid is a selective noncompetitive and reversible inhibitor of inos…
Food interactions
1 warning
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
360 mg
Half-life
16 hours
Protein binding
98%
[L42165]
Volume of distribution
54 L
Metabolism
Elimination
60%
[L42165]…
Clearance
140 mL/min
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
[L42165]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1274 interactions
[L42165]
It may be appropriate to interrupt or discontinue mycophenolic acid if blood dyscrasias occur.
Some of the signs and symptoms associated with mycophenolic acid overdose are hematological abnormalities, such as leukopenia and neutropenia, and gastrointestinal symptoms, such as abdominal pain, diarrhea, nausea and vomiting, and dyspepsia.
[L42165]
Carcinogenicity studies of 104 weeks done in rats and mice, suggest that mycophenolate sodium does not induce the formation of tumours. Rats were given up to 9 mg/kg of mycophenolate sodium, which corresponded to 0.6-1.2 times the systemic exposure observed in renal transplant patients, while mice were given 180 mg/kg, an equivalent of 0.6 times the mycophenolate sodium therapeutic dose.
[L42165]
The genotoxicity of mycophenolate sodium was confirmed by the mouse lymphoma/thymidine kinase assay, the micronucleus test in V79 Chinese hamster cells, and the in vivo mouse micronucleus assay. Mycophenolate mofetil, a prodrug of mycophenolic acid, had a similar genotoxic profile.
At daily oral doses as high as 18 mg/kg and 20 mg/kg, mycophenolate sodium had no effect on male and female rat fertility, respectively.
[L42165]
The oral LD50 of mycophenolic acid is 352 mg/kg in rats and 1000 mg/kg in mice.
[L42180]
Patients treated with mycophenolic acid have a higher risk of developing new or reactivated viral infections, serious infections, blood dyscrasias (including pure red cell aplasia), serious gastrointestinal tract complications, acute inflammatory syndrome associated with mycophenolate products, lymphoma, and other malignancies.[L42165] The use of mycophenolic acid is also associated with an increased risk of first-trimester pregnancy loss and congenital malformations. Mycophenolic acid should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). Patients treated with mycophenolic acid should not receive live attenuated vaccines or donate blood or semen.[L42165]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L42165]
In renal transplant patients, the median delay (Tlag) in the rise of mycophenolic acid concentration ranged between 0.25 and 1.25 hours, and the Tmax ranged between 1.5 and 2.75 hours.
Adult renal transplant patients on cyclosporine given mycophenolic acid had a Tmax of 2 h, a Cmax of 26.1 μg/mL, and an AUC0-12 of 66.5 μg⋅h/mL. Stable pediatric (5-16 years old) renal transplant patients had a Cmax and AUC 33% and 18% higher than the ones detected in adults.
[L42165]
In stable renal transplant patients treated with cyclosporine, the gastrointestinal absorption and absolute bioavailability of delayed-release tablets of mycophenolic acid were 93% and 72%, respectively.
[L42165]
Following the administration of a high-fat meal (55 g fat, 1000 calories), the AUC of mycophenolic acid (enteric-coated tablets, 720 mg) was comparable to the one detected during fasting. However, a high-fat meal can lead to a 33% decrease of the Cmax, a 3.5-hour delay in the Tlag (range of -6 to 18 hours), and a 5.0-hour delay in the Tmax (range of -9 to 20 hours).
To avoid variability in the absorption of mycophenolic acid, this drug should be taken on an empty stomach.
[L42165]
[L42165]
[L42165]
[L42165]
The AUC ratio of mycophenolic acid:MPAG:acyl glucuronide is approximately 1:24:0.28 at a steady state.
[L42165]
[L42165]
MPAG is also secreted in the bile and is available for deconjugation by gut flora. The mycophenolic acid that results from MPAG deconjugation may be reabsorbed and produce a second peak 6-8 hours after administration.
[L42165]
[L42165]
Proteins and enzymes this drug interacts with in the body
PMID:7763314 PMID:7903306
Could also have a single-stranded nucleic acid-binding activity and could play a role in RNA and/or DNA metabolism .
PMID:14766016
It may also have a role in the development of malignancy and the growth progression of some tumors
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that carry this drug through the body
PMID:19021548
Major calcium and magnesium transporter in plasma, binds approximately 45% of circulating calcium and magnesium in plasma (By similarity).
Potentially has more than two calcium-binding sites and might additionally bind calcium in a non-specific manner (By similarity). The shared binding site between zinc and calcium at residue Asp-273 suggests a crosstalk between zinc and calcium transport in the blood (By similarity). The rank order of affinity is zinc > calcium > magnesium (By similarity).
Binds to the bacterial siderophore enterobactin and inhibits enterobactin-mediated iron uptake of E.coli from ferric transferrin, and may thereby limit the utilization of iron and growth of enteric bacteria such as E.coli .
PMID:6234017
Does not prevent iron uptake by the bacterial siderophore aerobactin PMID:6234017
ATC L04AA06
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Mycophenolic acid
Additional database identifiers
Drugs Product Database (DPD)
2139
ChemSpider
393865
BindingDB
19264
PDB
MOA
ZINC
ZINC000000001758
HUGO Gene Nomenclature Committee (HGNC)
HGNC:6053
GenAtlas
IMPDH2
GeneCards
IMPDH2
GenBank Gene Database
J04208
GenBank Protein Database
307066
Guide to Pharmacology
2625
UniProt Accession
IMDH2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:6052
GenAtlas
IMPDH1
GeneCards
IMPDH1
GenBank Gene Database
J05272
GenBank Protein Database
307067
Guide to Pharmacology
2624
UniProt Accession
IMDH1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12554
GeneCards
UGT2B7
GenBank Gene Database
J05428
GenBank Protein Database
340080
UniProt Accession
UD2B7_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12540
GeneCards
UGT1A8
GenBank Gene Database
AF030310
GenBank Protein Database
2613044
UniProt Accession
UD18_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12541
GeneCards
UGT1A9
GenBank Gene Database
S55985
GenBank Protein Database
7690346
UniProt Accession
UD19_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12530
GeneCards
UGT1A1
GenBank Gene Database
M57899
GenBank Protein Database
184473
Guide to Pharmacology
2990
UniProt Accession
UD11_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12539
GeneCards
UGT1A7
UniProt Accession
UD17_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12531
GeneCards
UGT1A10
GenBank Gene Database
U89508
GenBank Protein Database
2039362
UniProt Accession
UD110_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12538
GeneCards
UGT1A6
UniProt Accession
UD16_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2638
GenAtlas
CYP3A5
GeneCards
CYP3A5
GenBank Gene Database
J04813
GenBank Protein Database
181346
Guide to Pharmacology
1338
UniProt Accession
CP3A5_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2622
GenAtlas
CYP2C8
GeneCards
CYP2C8
GenBank Gene Database
M17397
Guide to Pharmacology
1325
UniProt Accession
CP2C8_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:399
GenAtlas
ALB
GeneCards
ALB
GenBank Gene Database
V00494
GenBank Protein Database
28590
UniProt Accession
ALBU_HUMAN
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q420553), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.