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The incidence of adverse events for Myfortic® (mycophenolic acid) (mycophenolic acid) was determined in randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and maintenance kidney transplant patients.

The principal adverse reactions associated with the administration of Myfortic (mycophenolic acid) include constipation, nausea, and urinary tract infection in de novo patients and nausea, diarrhea and nasopharyngitis in maintenance patients.

Adverse events reported in ≥ 20% of patients receiving Myfortic (mycophenolic acid) or mycophenolate mofetil in the 12-month de novo renal study and maintenance renal study, when used in combination with cyclosporine, USP (MODIFIED) and corticosteroids, are listed in Table 4. Adverse event rates were similar between Myfortic (mycophenolic acid) and mycophenolate mofetil in both de novo and maintenance patients.

TABLE 4 : ADVERSE EVENTS (%) IN CONTROLLED DE NOVO AND MAINTENANCE RENAL STUDIES REPORTED IN ≥ 20% OF PATIENTS

Table 5 summarizes the incidence of opportunistic infections in de novo and maintenance transplant patients, which were similar in both treatment groups.

TABLE 5 VIRAL AND FUNGAL INFECTIONS (%) REPORTED OVER 0-12 MONTHS

The following opportunistic infections occurred rarely in the above controlled trials: aspergillus and cryptococcus.

The incidence of malignancies and lymphoma is consistent with that reported in the literature for this patient population. Lymphoma developed in 2 de novo patients (0.9%), (one diagnosed 9 days after treatment initiation) and in 2 maintenance patients (1.3%) (one was AIDS-related), receiving Myfortic (mycophenolic acid) with other immunosuppressive agents in the 12-month controlled clinical trials. Nonmelanoma skin carcinoma occurred in 0.9% de novo and 1.8% maintenance patients. Other types of malignancy occurred in 0.5% de novo and 0.6% maintenance patients.

The following adverse events were reported between 3% to < 20% incidence in de novo and maintenance patients treated with Myfortic (mycophenolic acid) in combination with cyclosporine and corticosteroids are listed in Table 6.

TABLE 6 : ADVERSE EVENTS REPORTED IN 3% TO < 20% OF PATIENTS TREATED WITH MYFORTIC® (mycophenolic acid) IN COMBINATION WITH CYCLOSPORINE* AND CORTICOSTEROIDS

The following additional adverse reactions have been associated with the exposure to MPA when administered as a sodium salt or as mofetil ester:

Gastrointestinal

Colitis (sometimes caused by CMV), pancreatitis, esophagitis, intestinal perforation, gastrointestinal hemorrhage, gastric ulcers, duodenal ulcers, and ileus (see PRECAUTIONS).

Resistance Mechanism Disorders

Serious life-threatening infections such as meningitis and infectious endocarditis have been reported occasionally and there is evidence of a higher frequency of certain types of serious infections such as tuberculosis and atypical mycobacterial infection.

Respiratory

Interstitial lung disorders, including fatal pulmonary fibrosis, have been reported rarely with MPA administration and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in posttransplant patients receiving MPA derivatives.

Postmarketing Experience

• Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with mycophenolate mofetil (MMF). Mycophenolate mofetil(MMF) is metabolized to mycophenolic acid (MPA), the active ingredient in Myfortic (mycophenolic acid) and the active form of the drug (see WARNINGS, Latent Viral Infections).
• BK virus-associated nephropathy has been observed in patients receiving immunosuppressants, including Myfortic (mycophenolic acid) . This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss (see WARNINGS, Latent Viral Infections).
• Congenital malformations have been reported in offspring of patients exposed to mycophenolate mofetil (MMF) during pregnancy (see WARNINGS, Pregnancy).
• Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents (see WARNINGS).

The following drug interaction studies have been conducted with Myfortic (mycophenolic acid) :

Antacids

Absorption of a single dose of Myfortic (mycophenolic acid) was decreased when administered to 12 stable renal transplant patients also taking magnesium-aluminum-containing antacids (30 mL): the mean Cmax and AUC(0-t) values for MPA were 25% and 37% lower, respectively, than when Myfortic (mycophenolic acid) was administered alone under fasting conditions. It is recommended that Myfortic (mycophenolic acid) and antacids not be administered simultaneously.

Cyclosporine

When studied in stable renal transplant patients, cyclosporine, USP (MODIFIED) pharmacokinetics were unaffected by steady-state dosing of Myfortic (mycophenolic acid) .

The following recommendations are derived from drug interaction studies conducted following the administration of mycophenolate mofetil:

Acyclovir/Ganciclovir

May be taken with Myfortic (mycophenolic acid) ; however, during the period of treatment, physicians should monitor blood cell counts. Both acyclovir/ganciclovir and MPAG concentrations are increased in the presence of renal impairment, their coexistence may compete for tubular secretion and further increase in the concentrations of the two.

Azathioprine/Mycophenolate Mofetil

Given that azathioprine and mycophenolate mofetil inhibit purine metabolism, it is recommended that Myfortic (mycophenolic acid) not be administered concomitantly with azathioprine or mycophenolate mofetil.

Cholestyramine and Drugs that Bind Bile Acids

These drugs interrupt enterohepatic recirculation and reduce MPA exposure when coadministered with mycophenolate mofetil. Therefore, do not administer Myfortic (mycophenolic acid) with cholestyramine or other agents that may interfere with enterohepatic recirculation or drugs that may bind bile acids, for example bile acid sequestrates or oral activated charcoal, because of the potential to reduce the efficacy of Myfortic (mycophenolic acid) .

Oral Contraceptives

Given the different metabolism of Myfortic (mycophenolic acid) and oral contraceptives, no drug interaction between these two classes of drug is expected. However, in a drug-drug interaction study, mean levonorgesterol AUC was decreased by 15% when coadministered with mycophenolate mofetil. Therefore, it is recommended that oral contraceptives are coadministered with Myfortic (mycophenolic acid) with caution and additional birth control methods be considered (see PRECAUTIONS, Pregnancy).

Live Vaccines

During treatment with Myfortic (mycophenolic acid) , the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective. Influenza vaccination may be of value. Prescribers should refer to national guidelines for influenza vaccination (see PRECAUTIONS, General).

Drugs that alter the gastrointestinal flora may interact with Myfortic (mycophenolic acid) by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption.

Last reviewed on RxList: 10/27/2009
This monograph has been modified to include the generic and brand name in many instances.