SPL Set ID: 5e5926a7-1de0-4b54-a5c0-286b6200ff82

Cyclosporine, the active principle in Sandimmune (cyclosporine) is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea . Chemically, cyclosporine is designated as [ R -[ R *, R *-( E )]]-cyclic(L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl-3-hydroxy- N ,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl). Sandimmune ® Soft Gelatin Capsules (cyclosporine capsules, USP) are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains: cyclosporine, USP…………………………………………………………………………………………25 mg alcohol, USP dehydrated………………………………………………………………max 12.7% by volume Each 100 mg capsule contains: cyclosporine, USP……………………………………………………………………………………….100 mg alcohol, USP dehydrated………………………………………………………………max 12.7% by volume Inactive ingredients: corn oil, gelatin, iron oxide red, linoleoyl macrogolglycerides, sorbitol, and titanium dioxide. May also contain glycerol. 100 mg capsules may contain iron oxide yellow. Sandimmune ® Oral Solution (cyclosporine oral solution, USP) is available in 50 mL bottles. Each mL contains: cyclosporine, USP……………………………………………………………………………………….100 mg alcohol, Ph. Helv. ……………………………………………………………………………12.5% by volume dissolved in an olive oil, Ph. Helv./Labrafil M 1944 CS (polyoxyethylated oleic glycerides) vehicle which must be further diluted with milk, chocolate milk, or orange juice before oral administration. Sandimmune ® Injection (cyclosporine injection, USP) is available in a 5 mL sterile ampul for intravenous (IV) administration. Each mL contains: cyclosporine, USP…………………………………………………………………………………………50 mg *Cremophor ® EL (polyoxyethylated castor oil)………………………………………………………..650 mg alcohol, Ph. Helv. ……………………………………………………………………………32.9% by volume nitrogen………………………………………………………………………………………………………….qs which must be diluted further with 0.9% Sodium Chloride Injection or 5% Dextrose Injection using appropriate aseptic technique before use. The chemical structure of cyclosporine (also known as cyclosporin A) is chemical structure of cyclosporine