Mycophenolic acid

Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Use in combination with cyclosporine and corticosteroids. Limitations of Use: Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably.

Mycophenolic acid (MPA), an immunosuppressant, is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways. MPA has cytostatic effects on lymphocytes. Mycophenolate sodium has been shown to prevent the occurrence of acute rejection in rat models of kidney and heart allotransplantation. Mycophenolate sodium also decreases antibody production in mice.

In adults: 720 mg by mouth, twice daily (1440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake. In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m 2 by mouth, twice daily (up to a maximum of 720 mg twice daily). Do not crush, chew, or cut tablet prior to ingestion.

History of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. Mycophenolic acid delayed-release tablets are contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients.

Boxed warning: 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. Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. New or Reactivated Viral Infections: Consider reducing immunosuppression. Blood Dyscrasias, including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia, consider treatment interruption or dose reduction. Serious GI Tract Complications (gastrointestinal bleeding, perforations and ulcers): Administer with caution to patients with active digestive system disease. Hypersensitivity Reactions: Discontinue mycophenolic acid delayed-release tablets, treat and monitor until signs and symptoms resolve.

The following adverse reactions are discussed in greater detail in other sections of the label. Embryo-Fetal Toxicity Lymphomas and Other Malignancies Serious Infections New or Reactivated Viral Infections Blood Dyscrasias, Including Pure Red Cell Aplasia Serious GI Tract Complications Acute Inflammatory Syndrome Associated with Mycophenolate Products Hypersensitivity Reactions Rare Hereditary Deficiencies Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.

Antacids with Magnesium and Aluminum Hydroxides: Decreases concentrations of MPA, concomitant use is not recommended. Azathioprine: Competition for purine metabolism, concomitant administration is not recommended. Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal, and Other Drugs that Interfere with Enterohepatic Recirculation: May decrease MPA concentrations, concomitant use is not recommended. Sevelamer: May decrease MPA concentrations, concomitant use is not recommended. Cyclosporine: May decrease MPA concentrations, exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine. Norfloxacin and Metronidazole: May decrease MPA concentrations, concomitant use with both drugs is not recommended. Rifampin: May decrease MPA concentrations, concomitant use is not recommended unless the benefit outweighs the risk.

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.