CYCLOSPORINE (Oral route, Intravenous route) - SYE-kloe-spor-een.(Drug overview)

Warning --

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune(R) (cyclosporine). 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.

Sandimmune(R) (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Sandimmune(R) soft gelatin capsules (cyclosporine capsules, USP) and Sandimmune(R) oral solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral(R) oral solution (cyclosporine oral solution, USP) MODIFIED.

Sandimmune(R) and Neoral(R) are not bioequivalent and cannot be used interchangeably without physician supervision.

The absorption of cyclosporine during chronic administration of Sandimmune(R) Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed .

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral(R). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral(R). 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 of the follow-up of the patient.

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

Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral(R) oral solution …