Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the inclusion criteria and report symptoms of gastrointestinal side-effects while taking Cellcept will be switched to Myfortic. All 20 patients will be followed closely over a period of 6 months following enrollment. Concomitant immunosuppressive therapy will continue in all patients per standard treatment protocol.

Inclusion criteria

• Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery.
• Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy.
• Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate.
• Patients who are able to give written informed consent.

Exclusion criteria

• Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia (hemoglobin < 6g/dl) at the time of potential enrollment.
• Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
• Known sensitivity to the study drug or class of the study drug.
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
• Use of any other investigational agent in the last 30 days.