Gengraf Oral Solution

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Gengraf®Oral Solution (cyclosporine oral solution, USP [MODIFIED]). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Gengraf®. Patients receiving the drug 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.

Gengraf®, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Gengraf®may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.

Gengraf®Oral Solution (cyclosporine oral solution, USP [MODIFIED]) has increased bioavailability in comparison to Sandimmune®Oral Solution (cyclosporine oral solution, USP). Gengraf®and Sandimmune®are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Gengraf®