Cyclosporine

BOXED WARNING

Quoted from the FDA label

Quoted in full from the FDA product label.

WARNING Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe cyclosporine capsules, (NON-MODIFIED). 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. Cyclosporine capsules, (NON-MODIFIED) 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. Cyclosporine capsules, (NON-MODIFIED) have decreased bioavailability in comparison to Neoral ® * (cyclosporine capsules, USP) MODIFIED. Cyclosporine capsules, (NON-MODIFIED) and Neoral ® * (cyclosporine capsules, USP) MODIFIED are not bioequivalent and cannot be used interchangeably without physician supervision. The absorption of cyclosporine during chronic administration of cyclosporine capsules, (NON-MODIFIED) was found to be erratic. It is recommended that patients taking cyclosporine capsules, (NON-MODIFIED) over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dose adjustments be made in order to avoid toxicity due to high concentrations 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 concentrations of cyclosporine. Comparison of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed. (See DOSAGE AND ADMINISTRATION, Blood Concentration Monitoring .)

INDICATIONS AND USAGE

Quoted from the FDA label

INDICATIONS AND USAGE Cyclosporine capsules, (NON-MODIFIED) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

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