There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
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|warnings=* Description
====Precautions====
* Description
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<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
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=====Metabolic and Nutritional=====
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<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
<!--Structure-->
|structure=*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
{{EH}}
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
'''Mycophenolic acid''' ([[International Nonproprietary Name|INN]]) ([[International Phonetic Alphabet|IPA]]: {{IPA|[ˌmaɪkoˈfɛnɒlɪk- ]}}) or '''mycophenolate''' is an [[Immunosuppression|immunosuppressant]] drug used to prevent [[Transplant_rejection|rejection]] in [[Organ_transplant|organ transplantation]]. It was initially marketed as the [[prodrug]] '''mycophenolate mofetil''' (abbreviated '''MMF''') to improve oral bioavailability. More recently, the salt '''mycophenolate sodium''' has also been introduced. Mycophenolic acid is commonly marketed under the trade names '''CellCept''' (mycophenolate mofetil; [[Hoffman-La Roche|Roche]]) and '''Myfortic''' (mycophenolate sodium; [[Novartis]]).
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
==Pharmacokinetics/pharmacology==
<!--Precautions with Alcohol-->
Mycophenolate is derived from the fungus ''[[Penicillium|Penicillium stoloniferum]]''. Mycophenolate mofetil is metabolised in the [[liver]] to the active moiety mycophenolic acid. It inhibits inosine monophosphate dehydrogenase, the [[enzyme]] which controls the rate of synthesis of guanine monophosphate in the ''[[de novo synthesis|de novo]]'' pathway of [[purine]] synthesis used in the proliferation of B and T [[lymphocytes]].
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Mycophenolate is potent and can be used in place of the older anti-proliferative [[azathioprine]]. It is usually used as part of triple-therapy including a calcineurin inhibitor ([[cyclosporin]] or [[tacrolimus]]) and prednisolone.
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
==Clinical use==
<!--Look-Alike Drug Names-->
===Indications===
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
Generally speaking, mycophenolate is used for the prevention of [[organ transplant]] [[transplant rejection|rejection]]. Specifically, mycophenolate mofetil is indicated for the prevention of organ transplant rejection in adults and renal transplant rejection in children >2 years; while mycophenolate sodium is indicated for the prevention of renal transplant rejection in adults. Mycophenolate sodium has also been used for the prevention of rejection in liver, heart and/or lung transplants in children >2 years.<ref name="AMH2006">Rossi S, editor. [[Australian Medicines Handbook]] 2006. Adelaide: Australian Medicines Handbook; 2006. ISBN 0-9757919-2-3
</ref>
Recently, several studies have shown that oral mycophenolate mofetil is effective in inducing and maintaining remission in [[lupus nephritis]].<ref name="Ginzler">Ginzler EM, Dooley MA, Aranow C, Kim MY, et al. "Mycophenolate Mofetil or Intravenous Cyclophosphamide for Lupus Nephritis." New England Journal of Medicine. 353:21. 2219-2229. 24 November 2005.</ref> It has been shown to be more effective and have fewer adverse effects than intravenous cyclophosphamide for lupus nephritis and has now become accepted first-line treatment for this disorder.
<!--Drug Shortage Status-->
|drugShortage=
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===Adverse effects===
Common [[adverse drug reaction]]s (≥1% of patients) associated with mycophenolate therapy include: diarrhea, nausea, vomiting, infections, [[leukopenia]], and/or [[anemia]]. Mycophenolate sodium is also commonly associated with fatigue, headache and/or cough. Intravenous (IV) administration of mycophenolate mofetil is also commonly associated with [[thrombophlebitis]] and [[thrombosis]]. Infrequent adverse effects (0.1–1% of patients) include: [[esophagitis]], [[gastritis]], [[gastrointestinal tract]] [[hemorrhage]], and/or invasive [[cytomegalovirus]] (CMV) infection.<ref name="AMH2006">Rossi S, editor. [[Australian Medicines Handbook]] 2006. Adelaide: Australian Medicines Handbook; 2006. ISBN 0-9757919-2-3
</ref>
===Comparison to other agents===
Compared with azathioprine it is more [[lymphocyte]]-specific and is associated with less [[bone marrow suppression]], fewer [[opportunistic infections]] and lower incidence of acute rejection.<!--
--><ref name="HealthTechnolAssess2005-Woodroffe">Woodroffe R, Yao G, Meads C, Bayliss S, Ready A, Raftery J, et al. Clinical and cost-effectiveness of newer immunosuppressive regimens in renal transplantation: a systematic review and modelling study. Health Technol Assess 2005;9(21):1-194. PMID 15899149</ref> The exact role of mycophenolate vs azathioprine has yet to be conclusively established, but many centers use it in place of azathioprine for high-risk patients, or patients who have already experienced an episode of acute rejection. In long-term immunosuppression, it may be used to avoid [[Immunosuppressive drug#Drugs acting on immunophilins|calcineurin inhibitors]] or steroids.
===Potential future uses===
<!--Label Display Image-->
Mycophenolate mofetil is beginning to be used in the management of [[idiopathic thrombocytopenic purpura]] (ITP) and [[systemic lupus erythematosus]] (SLE) with success for some patients.
It is also currently being used as a long term therapy for maintaining remission of [[Wegener's Granulomatosis]]. It is being studied, along with [[ribavirin]], for use against [[dengue]].
*[http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/203436.html MedlinePlus drug information: mycophenolate (systemic)] – information from USP DI Advice for the Patient
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Mycophenolate sodium is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
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Condition2
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
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Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Mycophenolate sodium in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
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Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Mycophenolate sodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Mycophenolate sodium in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Mycophenolate sodium in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Mycophenolate sodium in pediatric patients.
Contraindications
Condition1
Warnings
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Mycophenolate sodium in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Mycophenolate sodium in the drug label.
