Label: MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet, film coated

  • NDC Code(s): 31722-879-01, 31722-879-05
  • Packager: Camber Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 7, 2024

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

    WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS

    • Use during pregnancy is associated with increased risks of first trimester 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 Special Populations (8.1, 8.3)].
    • Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2)].
    • Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3)
    ].



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  • 1 INDICATIONS AND USAGE
    Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney - [see - Clinical Studies ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Mycophenolate mofetil is available in the following dosage form and strength: Tablets - 500 mg mycophenolate mofetil, lavender-color, capsule shaped, biconvex, film- coated tablets ...
  • 4 CONTRAINDICATIONS
    Allergic reactions to mycophenolate mofetil tablets have been observed; therefore, Mycophenolate mofetil tablet is contraindicated in patients with a hypersensitivity to mycophenolate mofetil ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Embryofetal Toxicity - Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the label: • Embryofetal Toxicity - [see - Warnings and Precautions (5.1)] • Lymphomas and ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Other Drugs on Mycophenolate Mofetil - Table 7 Drug Interactions with Mycophenolate Mofetil that Affect Mycophenolic Acid (MPA) Exposure - Antacids with Magnesium or Aluminum ...
  • 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
    Possible signs and symptoms of acute overdose include hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea ...
  • 11 DESCRIPTION
    Mycophenolate mofetil, USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was ...
  • 14 CLINICAL STUDIES
    14.1 Kidney Transplantation - Adults - The three - de novokidney transplantation studies compared two dose levels of oral mycophenolate mofetil (1 g twice daily and 1.5 g twice daily) with ...
  • 15 REFERENCES
    1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 Handling and Disposal - Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans - [see - Warnings and Precautions (5.1) and - Use in Specific Populations (8.1) ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use). 17.1 Embryofetal Toxicity - Pregnancy loss and malformations - • Inform females ...
  • MEDICATION GUIDE
    Mycophenolate Mofetil Tablets, USP - (mye'' koe fen' oh late moe' fe til)  Read the Medication Guide that comes with mycophenolate mofetil tablets before you start ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    100's count label
  • INGREDIENTS AND APPEARANCE
    Product Information