Mycophenolate sodium

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]

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Black Box Warning

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS See full prescribing information for complete Boxed Warning. * Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Females of reproductive potential must be counseled regarding pregnancy prevention and planning, Use in Specific Populations. Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions. 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.

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.

Dosage

Dosage in Adult Kidney Transplant Patients

The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).

Dosage in Pediatric Kidney Transplant Patients

The recommended dose of mycophenolic acid in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily).

DOSAGE FORMS AND STRENGTHS

Mycophenolic acid delayed-release tablets are available as 180 mg and 360 mg tablets.

This image is provided by the National Library of Medicine.

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. * Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Females of reproductive potential must be counseled regarding pregnancy prevention and planning, Use in Specific Populations. Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions. 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.

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

• ORAL

• Mycophenolic acid delayed-release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake.

• Mycophenolic acid delayed-release tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.

• Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three mycophenolic acid 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1080 mg daily dose). Patients with a BSA of >1.58 m2 may be dosed either with four mycophenolic acid 180 mg tablets, or two mycophenolic acid 360 mg tablets twice daily (1440 mg daily dose). Pediatric doses for patients with BSA <1.19 m2 cannot be accurately administered using currently available formulations of mycophenolic acid tablets.

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

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Package and Label Display Panel

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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.