Sandimmune

BOXED WARNING

Quoted from the FDA label

Quoted in full from the FDA product label.

WARNING: RECOMMENDATIONS FOR USE, USE WITH CORTICOSTERIODS, RISKS WITH INAPPROPRIATE SWITCHING, and MONITORING CYCLOSPORINE BLOOD LEVELS Recommendations for Use Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune. Patients receiving Sandimmune 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. Use with Corticosteroids Sandimmune 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. Risks with Inappropriate Switching Between Neoral Capsules (MODIFIED) and Sandimmune Capsules Do not switch between Sandimmune capsules, 25 mg to Neoral capsules, MODIFIED, 25 mg (or between Sandimmune capsules, 100 mg to Neoral capsules, MODIFIED 100 mg) on a mg-to-mg basis to achieve the same total daily cyclosporine dosage. Inappropriate switching may lead to increased cyclosporine exposure which may increase the risk of cyclosporine-associated adverse reactions or decreased cyclosporine exposure which may decrease the efficacy of cyclosporine. Monitoring Cyclosporine Blood Levels The absorption of cyclosporine during chronic administration of Sandimmune capsules was found to be erratic. It is recommended that patients taking the Sandimmune capsules over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dosage 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 Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune injection should be reserved for patients who are unable to take the Sandimmune capsules.

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