cycloSPORINE (Systemic)

Warning

Supervising Clinician and Medical Resources

• Only clinicians experienced in management of systemic immunosuppressive therapy for the indicated disease and/or management of organ transplant patients should prescribe cyclosporine.

• Patients should be managed in facilities with adequate laboratory and supportive medical resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up.

Effects of Immunosuppression

• Immunosuppression may result in increased susceptibility to infection and possible development of lymphoma or other neoplasms. (See Lymphomas and Other Malignancies under Cautions.)

• Manufacturer cautions that conventional (nonmodified) oral formulations and the concentrate for injection should be administered with corticosteroids but not with other immunosuppressive agents in organ transplant recipients. Manufacturers state that modified oral formulations of cyclosporine (Neoral and Gengraf) may be administered with oral immunosuppressive agents in transplant patients, although the degree of immunosuppression produced may result in increased susceptibility to infection and possible development of lymphoma and other neoplasms.

Bioequivalency of Formulations

• Conventional (nonmodified) oral formulations (Sandimmune liquid-filled capsules and solution) have decreased bioavailability compared with modified oral formulations (Neoral and Gengraf liquid-filled capsules and solution). Conventional (nonmodified) and modified formulations ar