Cyclosporine Capsules and Oral Solution Modified

Brand Name

Neoral® Gengraf

Cyclosporine Cyclosporine

Company

Novartis1 Abbott Eon3

Laboratories/SangStat2

Sidmak4

Class

Immunosuppressant produced as a metabolite by the fungus species Beauvaria nivea Gams1; Aphanocladium album2; Cordyceps militarist-'4

Mechanism of Action

Preferential inhibition of T lymphocytes

Suppresses activation of T lymphocytes by inhibiting production and release of lymphokines, specifically interleukin-2

Indications

Prophylaxis of graft rejection in kidney, liver, and heart allogeneic transplantation

Rheumatoid arthritis

Psoriasis

Contraindication

Hypersensitivity to cyclosporine or any of the ingredients of the formulation

Warnings

Nephrotoxicity Hepatotoxicity

Increased susceptibility to infection and lymphoma Reports of convulsions in pediatric and adult patients, especially when used in conjunction with methylprednisolone Modified cyclosporine is not bioequivalent to Sandimmune

Special Precautions

Any change in cyclosporine formulation should be made cautiously and under the advisement of a physician—Patients should be given detailed dosage instructions

Hypertension may occur and require therapy with antihypertensives (potassium-sparing diuretics should not be used)

Repeated laboratory monitoring is required Pregnancy Category C

Adverse Reactions

Renal dysfunction Tremor Hirsutism Hypertension Gum hyperplasia

Hyperkalemia

Hyperurecemia

Encephalopathy

Drug Interactions

Drugs with Synergistic Nephrotoxicity

• Tobramycin • Ketoconazole

• Ranitidine • Azapropazon

Drugs that Increase Cyclosporine Levels

• Diltiazem • Clarithromycin

Naproxen

Sulindac

Colchicine

Non-Steroidal

Anti-

inflammatory agents

Appendix I

Cyclosporine Capsules and Oral Solution (Modified) (cont'd)

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