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NEORAL (CYCLOSPORINE) CAPSULES AND ORAL SOLUTION: CLINICAL PHARMACOLOGY

Neoral (Cyclosporine) is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, liver, kidney, heart, bone marrow, pancreas, small intestine, and lung. Cyclosporine has been demonstrated to suppress some humoral immunity and to a greater extent, cellmediated immune reactions such as allograft rejection, experimental allergic encephalomyelitis, delayed hypersensitivity, Freund's adjuvant arthritis, and graft vs. host disease in many animal species for a variety of organs.

The effectiveness of cyclosporine results from specific and reversible inhibition of immunocompetent lymphocytes in the G0- and G1-phase of the cell cycle. T-lymphocytes are preferentially inhibited. The T-helper cell is the main target, although the T-suppressor cell may also be suppressed. Cyclosporine also inhibits lymphokine production and release including interleukin-2.

No effects on phagocytic function (changes in enzyme secretions, chemotactic migration of granulocytes, macrophage migration, carbon clearance in vivo) have been detected in animals. Cyclosporine does not cause bone marrow suppression in animal models or man.

Drug Interactions

When diclofenac or methotrexate was co-administered with Neoral (Cyclosporine) capsules and oral solution in rheumatoid arthritis patients, the AUC of diclofenac and methotrexate, each was significantly increased.

No clinically significant pharmacokinetic interactions occurred between cyclosporine and ketoprofen, aspirin, piroxicam, or indomethacin.

Pharmacokinetics in Special Populations

Pediatric Population

Pharmacokinetic data from pediatric patients administered Neoral or Sandimmune are very limited. In 15 renal transplant patients aged 3-16 years, cyclosporine whole blood clearance after IV administration of Sandimmune was 10.6±3.7 mL/min/kg (assay: Cyclo-trac specific RIA). In a study of 7 renal transplant patients aged 2-16, the cyclosporine clearance ranged from 9.8-15.5 mL/min/kg. In 9 liver transplant patients aged 0.6-5.6 years, clearance was 9.3±5.4 mL/min/kg (assay: HPLC).

In the pediatric population, Cyclosporine (Neoral) capsules and oral solution also demonstrates an increased bioavailability as compared to Sandimmune. In 7 liver de novo transplant patients aged 1.4-10 years, the absolute bioavailability of Neoral was 43% (range 30%-68%) and for Sandimmune in the same individuals absolute bioavailability was 28% (range 17%-42%).

Geriatric Population

Comparison of single dose data from both normal elderly volunteers (N=18, mean age 69 years) and elderly rheumatoid arthritis patients (N=16, mean age 68 years) to single dose data in young adult volunteers (N=16, mean age 26 years) showed no significant difference in the pharmacokinetic parameters.

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