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 are not bioequivalent and cannot be used interchangeably without physician supervision. (See Conversion from Conventional Oral Formulations [Sandimmune®] to Modified Oral Formulations [Gengraf®, Neoral®] under Dosage and Administration.)
Absorption of cyclosporine during chronic administration of Sandimmune® capsules and oral solution may be erratic. Patients, especially liver transplant recipients, receiving these formulations over a period of time should be monitored at repeated intervals for blood cyclosporine concentrations and possible organ rejection due to low absorption of cyclosporine.
For a given trough concentration, cyclosporine exposure will be greater with Neoral® or Gengraf® preparations than with Sandimmune® preparations. Exercise particular caution if a patient is receiving exceptionally high doses of Sandimmune® and is converted to Gengraf® or Neoral®. (See Conversion from Conventional Oral Formulations [Sandimmune®] to Modified Oral Formulations [Gengraf®, Neoral®] under Dosage and Administration.)
Patients receiving Gengraf® or Neoral® liquid-filled capsules or oral solution for organ transplant or in the management of rheumatoid arthritis should also have blood cyclosporine concentrations monitored to avoid toxicity due to high concentrations. (See Monitoring of Cyclosporine Concentrations under Cautions.)
Psoriasis Patients
Previous therapy with psoralen and UVA light (PUVA) and, to a lesser extent, methotrexate, other immunosuppressive agents, UVB, coal tar, or radiation therapy may increase risk of skin malignancies in patients receiving cyclosporine.
Recommended dosages can cause hypertension and nephrotoxicity; risk increases with dose and duration of therapy. Monitor renal function (see General: Psoriasis, under Dosage and Administration).
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