Mycophenolate sodium: Difference between revisions

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|aOrAn=a
|aOrAn=a
|indicationType=prophylaxis
|indicationType=prophylaxis
|indication=organ rejection  
|indication=organ rejection
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=[[anemia]], [[leukopenia]], [[constipation]], [[nausea]], [[diarrhea]], [[vomiting]], [[dyspepsia]], [[urinary tract infection]], [[CMV infection]], [[insomnia]], and [[postoperative pain]]
|adverseReactions=[[anemia]], [[leukopenia]], [[constipation]], [[nausea]], [[diarrhea]], [[vomiting]], [[dyspepsia]], [[urinary tract infection]], [[CMV infection]], [[insomnia]], and [[postoperative pain]]
|blackBoxWarningTitle=WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
|blackBoxWarningTitle=WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
|blackBoxWarningBody=* Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations.
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult===Indications==
'''Prophylaxis of Organ Rejection in Kidney Transplant'''


* Females of reproductive potential must be counseled regarding pregnancy prevention and planning.
Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.  


* Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression.
Mycophenolic acid is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.  


* Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions.
Mycophenolic acid is to be used in combination with cyclosporine and corticosteroids.


* Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid. Patients receiving mycophenolic acid should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions.
'''Limitations of Use'''
|fdaLIADAdult======Condition1=====


* Dosing Information
Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Mycophenolic acid in adult patients.
:* Dosage
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Mycophenolic acid in adult patients.
 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Mycophenolic acid in pediatric patients.
=====Condition2=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Mycophenolic acid in pediatric patients.
 
|alcohol=Alcohol-Mycophenolic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======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 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
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--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=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--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
 
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|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
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|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===
 
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<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
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|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
 
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|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>
 
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[[Category:Drug]]

Revision as of 17:28, 15 January 2015

Mycophenolate sodium
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Mycophenolate sodium is a {{{drugClass}}} that is FDA approved for the prophylaxis of organ rejection. There is a Black Box Warning for this drug as shown here. Common adverse reactions include anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Prophylaxis of Organ Rejection in Kidney Transplant

Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Mycophenolic acid is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

Mycophenolic acid is to be used in combination with cyclosporine and corticosteroids.

Limitations of Use

Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mycophenolic acid in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mycophenolic acid in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Mycophenolate sodium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mycophenolic acid in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mycophenolic acid in pediatric patients.

Contraindications

There is limited information regarding Mycophenolate sodium Contraindications in the drug label.

Warnings

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

There is limited information regarding Mycophenolate sodium Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Mycophenolate sodium Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Mycophenolate sodium Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Mycophenolate sodium Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Mycophenolate sodium in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mycophenolate sodium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mycophenolate sodium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Mycophenolate sodium in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Mycophenolate sodium in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Mycophenolate sodium in geriatric settings.

Gender

There is no FDA guidance on the use of Mycophenolate sodium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mycophenolate sodium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mycophenolate sodium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mycophenolate sodium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mycophenolate sodium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mycophenolate sodium in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Mycophenolate sodium Administration in the drug label.

Monitoring

There is limited information regarding Mycophenolate sodium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Mycophenolate sodium and IV administrations.

Overdosage

There is limited information regarding Mycophenolate sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Mycophenolate sodium Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Mycophenolate sodium Mechanism of Action in the drug label.

Structure

There is limited information regarding Mycophenolate sodium Structure in the drug label.

Pharmacodynamics

There is limited information regarding Mycophenolate sodium Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Mycophenolate sodium Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Mycophenolate sodium Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Mycophenolate sodium Clinical Studies in the drug label.

How Supplied

There is limited information regarding Mycophenolate sodium How Supplied in the drug label.

Storage

There is limited information regarding Mycophenolate sodium Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Mycophenolate sodium |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Mycophenolate sodium |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Mycophenolate sodium Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Mycophenolic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Mycophenolate sodium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Mycophenolate sodium Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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