Label: MYCOPHENOLIC ACID tablet, delayed release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 15, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MYCOPHENOLIC ACID ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS

    • Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].

    • Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid delayed-release tablets. Patients receiving mycophenolic acid delayed-release tablets 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 (5.2)].

    • Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.3)].

    • Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.4, 5.5)].

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  • 1 INDICATIONS AND USAGE
    1.1 Prophylaxis of Organ Rejection in Kidney Transplant - Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage in Adult Kidney Transplant Patients - The recommended dose of mycophenolic acid delayed-release tablets are 720 mg administered twice daily (1,440 mg total daily dose). 2.2 Dosage ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Mycophenolic acid delayed-release tablets, USP are available as 360 mg and 180 mg tablets. Table 1: Description of mycophenolic acid delayed-release tablets - Dosage Strength - 360 mg ...
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity Reactions - Mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Embryo-Fetal Toxicity - Use of mycophenolic acid delayed-release tablets during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the label. • Embryo-Fetal Toxicity [see Boxed Warning, Warnings and Precautions (5.1)]  • Lymphomas and Other ...
  • 7 DRUG INTERACTIONS
    7.1 Antacids With Magnesium and Aluminum Hydroxides - Concomitant use of mycophenolic acid delayed-release tablets and antacids decreased plasma concentrations of mycophenolic acid (MPA). It is ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry  - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming ...
  • 10 OVERDOSAGE
    Signs and Symptoms - There have been anecdotal reports of deliberate or accidental overdoses with mycophenolic acid delayed-release tablets, whereas not all patients experienced related adverse ...
  • 11 DESCRIPTION
    Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Mycophenolic acid (MPA), an immunosuppressant, is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 104-week oral carcinogenicity study in rats, mycophenolate sodium was not tumorigenic at daily doses up to 9 mg per kg, the ...
  • 14 CLINICAL STUDIES
    14.1 Prophylaxis of Organ Rejection in Patients Receiving Allogeneic Renal Transplants - The safety and efficacy of mycophenolic acid in combination with cyclosporine, USP MODIFIED and ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Mycophenolic Acid Delayed-Release Tablets, USP : 360 mg tablet: Pale orange-red colored, oval shaped, biconvex, film coated tablets imprinted “MA 360" with black ink on one side and plain on ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity - Pregnancy loss and malformations - • Inform pregnant women and females of reproductive ...
  • MEDICATION GUIDE
    mycophenolic acid (mye" koe fe nol' ik as' id) delayed-release tablets, USP - Read the Medication Guide that comes with mycophenolic acid delayed-release tablets before you start taking it and ...
  • Package/Label Display Panel
    MAJOR® NDC 0904-7372-61 - Unit Dose - Mycophenolic Acid - Delayed-Release - Tablets, USP - 360 mg - Pharmacist: Dispense with - Medication Guide - 100 TABLETS (10 x 10) Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information