CycloSPORINE (Cyclosporin A)(sye’ kloe spor een)
Gengraf, Neoral, Sandimmune
PREGNANCY CATEGORY C
Drug Classes
Immunosuppressant
Therapeutic Actions
Exact mechanism of immunosuppressant is not known; specifically and reversibly inhibits immunocompetent lymphocytes in the G0 or G1 phase of the cell cycle; inhibits T-helper and T-suppressor cells, lymphokine production, and release of interleukin-2 and T-cell growth factor.
Indications
Prophylaxis for organ rejection in kidney, liver, and heart transplants in conjunction with adrenal corticosteroids
Treatment of chronic rejection in patients previously treated with other immunosuppressive agents (Sandimmune)
Neoral, Gengraf: Alone, or in combination with methotrexate for treatment of patients with severe active rheumatoid arthritis
Neoral, Gengraf: Treatment of recalcitrant, plaque psoriasis in non–immune-compromised adults
Unlabeled uses: Aplastic anemia; resistant leukemias; other procedures, including pancreas, bone marrow, lung transplants; Crohn disease, SLE, MS
Contraindications and Cautions
Contraindicated with allergy to cyclosporine or polyoxyethylated castor oil, lactation.
Use cautiously with impaired renal function, malabsorption, pregnancy, uncontrolled hypertension.
Available Forms
Capsules—25, 100 mg; soft gel capsules for microemulsion—25, 50, 100 mg; oral solution—100 mg/mL; IV solution—50 mg/mL
Dosages
Adults and pediatric patients
Neoral, Gengraf, and Sandimmune are not bioequivalent—do not interchange. Concentrations should be monitored when switching because of variable bioavailability.
Oral
Organ rejection: 15 mg/kg/day PO (Sandimmune) initially given 4–12 hr prior to transplantation; continue dose postoperatively for 1–2 wk, then taper by 5% per wk to a maintenance level of 5–10 mg/kg/day.
Rheumatoid arthritis: 2.5 mg/kg/day (Neoral, Gengraf) PO in divided doses bid; may increase up to 4 mg/kg/day. If no benefit after 16 wks, discontinue drug.
Psoriasis: 2.5 mg/kg/day (Neoral, Gengraf) PO divided bid for 4 wk, then may increase up to 4 mg/kg/day. If no satisfactory response after 6 wk at 4 mg/kg/day, discontinue drug.
Parenteral
Patients unable to take oral solution preoperatively or postoperatively may be given IV
infusion (Sandimmune) at one-third the oral dose (ie, 5–6 mg/kg/day given 4–12 hr prior to transplantation, administered as a slow infusion over 2–6 hr). Continue this daily dose postoperatively. Switch to oral drug as soon as possible.
infusion (Sandimmune) at one-third the oral dose (ie, 5–6 mg/kg/day given 4–12 hr prior to transplantation, administered as a slow infusion over 2–6 hr). Continue this daily dose postoperatively. Switch to oral drug as soon as possible.
Pharmacokinetics
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