Immunosuppressant, selective inosine monophosphate dehydrogenase inhibitor
Brand names: CellCept, Myfortic
Updated · Methodology
First line
Mycophenolate mofetil is first-line for rejection prophylaxis after kidney, heart and liver transplantation, usually combined with tacrolimus or ciclosporin and a glucocorticoid. and AEMPS approved. Requires CBC monitoring (myelosuppression risk) and strict contraception in women of childbearing age due to high teratogenic risk.
Sources
ICD-10: Z94 · ICD-11: QB63
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Mycophenolate mofetil is an antimetabolite immunosuppressant. It is prescribed to prevent organ transplant rejection and for severe autoimmune diseases (systemic lupus erythematosus, vasculitis) when other drugs are ineffective (AEMPS Ficha Técnica). In alt-anti-aging circles, mycophenolate mofetil is occasionally promoted as a selective immunosuppressant to slow immune aging. In healthy adults, no clinical studies of such use exist. The drug has serious risks: myelosuppression (neutropenia, lymphopenia, anemia), GI disturbances (severe diarrhea in 30% of patients), opportunistic infections, increased lymphoma and other malignancy risk, and significant teratogenicity ( boxed warning, mandatory contraception). If mycophenolate mofetil was recommended to a healthy person, seek a second opinion immediately.
Prodrug hydrolysed in plasma to active mycophenolic acid. Selectively blocks type II inosine monophosphate dehydrogenase, the purine synthesis enzyme in T and B lymphocytes. Suppresses lymphocyte proliferation without significant effect on neutrophils. Metabolised via UGT1A9, not CYP. Excreted in bile and urine.
Boxed warning
FDA boxed warning: embryo-fetal toxicity (marked teratogenicity – cleft lip/palate, ear and cardiac defects; T1 spontaneous abortion risk up to 45%); increased risk of malignancies (especially lymphoma and skin); increased risk of serious infections.
Teratogen: high miscarriage and malformation risk (cleft lip/palate, ear/heart/oesophageal defects). Strictly contraindicated in pregnancy. Women of childbearing age need confirmed contraception 1 month before, during and 6 weeks after withdrawal.
Milk excretion data conflicting. Breastfeeding not recommended.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«Interacciones: No se recomienda administrar micofenolato de mofetilo al mismo tiempo que azatioprina, ya que no se ha estudiado su administración concomitante.»AEMPS, section 4.4 · Open on CIMA
«Antiácidos e inhibidores de la bomba de protones (IBPs): Se debe tener precaución cuando se empleen medicamentos que interfieran con la recirculación enterohepática debido a su potencial para reducir…»AEMPS, section 4.5 · Open on CIMA
«Antiácidos e inhibidores de la bomba de protones (IBPs): Se debe tener precaución cuando se empleen medicamentos que interfieran con la recirculación enterohepática debido a su potencial para reducir…»AEMPS, section 4.5 · Open on CIMA
«Effect of Other Drugs on Mycophenolate Mofetil: Prevention or Management Monitor patients for alterations in efficacy when PPIs are co-administered with mycophenolate mofetil.»FDA, section 7 · Open on DailyMed
«Rifampicina: En los pacientes que no estén tomando también ciclosporina, la administración concomitante de micofenolato de mofetilo y rifampicina da lugar a una disminución en la exposición al MPA…»AEMPS, section 4.5 · Open on CIMA
«Trimetoprim/AEMPS, section 4.5 · Open on CIMA
«Aciclovir: Se observaron concentraciones plasmáticas más altas de aciclovir cuando micofenolato de mofetilo se administró con aciclovir, en comparación con la administración de aciclovir sólo. Los…»AEMPS, section 4.5 · Open on CIMA
«Los antibióticos que el iminan en el intestino bacterias productoras de ?? glucuronidasa (por ejemplo, aminoglucósidos, cefalosporinas, fluoroquinolonas y penicilina) pueden interferir con la…»AEMPS, section 4.5 · Open on CIMA
«Effect of Other Drugs on Mycophenolate Mofetil: Examples Cyclosporine A, trimethoprim/FDA, section 7 · Open on DailyMed
«Ciprofloxacino o amoxicilina más ácido clavulánico: En pacientes que han recibido un trasplante de riñón, se han notificado casos en los que la concentración de MPA en la dosis inicial se reduce en…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs…»FDA, section 7 · Open on DailyMed
«Ciprofloxacino o amoxicilina más ácido clavulánico: En pacientes que han recibido un trasplante de riñón, se han notificado casos en los que la concentración de MPA en la dosis inicial se reduce en…»AEMPS, section 4.5 · Open on CIMA
«Effect of Mycophenolate Mofetil on Other Drugs: Clinical Impact Concomitant use with mycophenolate mofetil decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure…»FDA, section 7 · Open on DailyMed
«Effect of Other Drugs on Mycophenolate Mofetil: Examples Cyclosporine A, trimethoprim/FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. (7.2)»FDA, section 7 · Open on DailyMed
«Medicamentos que afectan a la glucuronidación (por ejemplo, isavuconazol, telmisartán)»AEMPS, section 4.5 · Open on CIMA
«Effect of Other Drugs on Mycophenolate Mofetil: Examples Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation).»FDA, section 7 · Open on DailyMed
«Antiácidos e inhibidores de la bomba de protones (IBPs): Se observó un descenso en la exposición del MPA cuando antiácidos, como hidróxidos de magnesio y aluminio, e IBPs, incluyendo lansoprazol y…»AEMPS, section 4.5 · Open on CIMA
«Effect of Other Drugs on Mycophenolate Mofetil: Examples Lansoprazole, pantoprazole»FDA, section 7 · Open on DailyMed
«Effect of Mycophenolate Mofetil on Other Drugs: Clinical Impact Concomitant use with mycophenolate mofetil decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure…»FDA, section 7 · Open on DailyMed
«Norfloxacino y metronidazol: No se ha observado interacción significativa en la administración concomitante de micofenolato de mofetilo con norfloxacino o con metronidazol en voluntarios sanos. Sin…»AEMPS, section 4.5 · Open on CIMA
«Norfloxacino y metronidazol: No se ha observado interacción significativa en la administración concomitante de micofenolato de mofetilo con norfloxacino o con metronidazol en voluntarios sanos. Sin…»AEMPS, section 4.5 · Open on CIMA
«Antiácidos e inhibidores de la bomba de protones (IBPs): Se observó un descenso en la exposición del MPA cuando antiácidos, como hidróxidos de magnesio y aluminio, e IBPs, incluyendo lansoprazol y…»AEMPS, section 4.5 · Open on CIMA
«Effect of Other Drugs on Mycophenolate Mofetil: Examples Lansoprazole, pantoprazole»FDA, section 7 · Open on DailyMed
«Los antibióticos que el iminan en el intestino bacterias productoras de ?? glucuronidasa (por ejemplo, aminoglucósidos, cefalosporinas, fluoroquinolonas y penicilina) pueden interferir con la…»AEMPS, section 4.5 · Open on CIMA
«Medicamentos que afectan a la glucuronidación (por ejemplo, isavuconazol, telmisartán)»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs…»FDA, section 7 · Open on DailyMed
«Effect of Other Drugs on Mycophenolate Mofetil: Examples Cyclosporine A, trimethoprim/FDA, section 7 · Open on DailyMed
«Aciclovir: Se observaron concentraciones plasmáticas más altas de aciclovir cuando micofenolato de mofetilo se administró con aciclovir, en comparación con la administración de aciclovir sólo. Los…»AEMPS, section 4.5 · Open on CIMA
«Effect of Mycophenolate Mofetil on Other Drugs: Examples Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir»FDA, section 7 · Open on DailyMed
«Interacciones que disminuyen los niveles de otros fármacos: La administración conjunta de ciclosporina y micofenolato de sodio o micofenolato de mofetilo en pacientes trasplantados puede disminuir la…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the…»FDA, section 7 · Open on DailyMed
«Micofenolato de mofetilo: Las sustancias que alteran la flora gastrointestinal (p. ej., antibióticos) pueden reducir la biodisponibilidad oral del ácido micofenólico. Durante el tratamiento…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Intervention: Mycophenolate mofetil (MMF): Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the…»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known…»FDA, section 7 · Open on DailyMed
«Se han mostrado aumentos en las AUCs plasmáticas de aciclovir y del metabolito inactivo de micofenolato de mofetilo, un agente inmunosupresor usado en pacientes trasplantados, cuando estos fármacos…»AEMPS, section 4.5 · Open on CIMA
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Mycophenolate mofetil is evaluated for the following indications with varying evidence strength: Transplant rejection prophylaxis (evidence tier A), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Mycophenolate mofetil (≥ 1 in 100): Nausea, vomiting, diarrhoea, Leukopenia, Anaemia, Urinary tract infections, Hypertension, Headache. See the Safety section for uncommon and serious reactions.
Teratogen: high miscarriage and malformation risk (cleft lip/palate, ear/heart/oesophageal defects). Strictly contraindicated in pregnancy. Women of childbearing age need confirmed contraception 1 month before, during and 6 weeks after withdrawal.
Milk excretion data conflicting. Breastfeeding not recommended.
Mycophenolate mofetil is contraindicated in: Pregnancy; Breastfeeding; Mycophenolic acid hypersensitivity; Severe active infections. Full list in the Safety section.
FDA boxed warning: embryo-fetal toxicity (marked teratogenicity – cleft lip/palate, ear and cardiac defects; T1 spontaneous abortion risk up to 45%); increased risk of malignancies (especially lymphoma and skin); increased risk of serious infections.
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