Note: Statements are present in all generic, Gengraf, Neoral, and Sandimmune boxed warnings, unless otherwise indicated.

Risk of Infection

Experienced Physicians/Equipped Facility

• For use by physicians experienced in management of systemic immunosuppressive therapy and organ transplant patients 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.

Increased Risk of Infection

• Use may increase the susceptibility to infection and the development of neoplasia (e.g. lymphoma) as a result of increased immunosuppression in transplant patients.
• Neoral, Gengraf:  May be administered with other immunosuppressive agents in kidney, liver, and heart transplant patients.
• Sandimmune, Generic: Should be administered with adrenal corticosteroids but not with other immunosuppressive agents.
• Injection formulation:  Should be administered with adrenal corticosteroids but not with other immunosuppressive agents.

Bioequivalency/Bioavailbility

• Sandimmune and generic cyclosporine are not bioequivalent to Neoral or Gengraf and can not be used interchangeably without physician supervision.
• Neoral soft gelatin capsules MODIFIED, Neoral  oral solution MODIFIED, and Gengraf  oral formulations have increased bioavailability in comparison to Sandimmune and generic soft gelatin capsules and oral solution.

For Psoriasis Patients (Neoral)

• Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral.
• Cyclosporine in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy.

Blood Concentrations/Monitoring