Sandimmune

Drug Description

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Sandimmune^Ò Soft Gelatin Capsules
(cyclosporine capsules, USP)

Sandimmune^Ò Oral Solution
(cyclosporine oral solution, USP)

Sandimmune^Ò Injection
(cyclosporine injection, USP)
FOR INFUSION ONLY

Rx only

WARNING

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune^Ã? (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Sandimmune^Ã? (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Sandimmune^Ã? Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune^Ã? Oral Solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral^Ã? Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral^Ã? Oral Solution (cyclosporine oral solution, USP) MODIFIED.

Sandimmune^Ã? and Neoral^Ã? are not bioequivalent and cannot be used interchangeably without physician supervision.

The absorption of cyclosporine during chronic administration of Sandimmune^Ã? Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed. (See Blood Level Monitoring under DOSAGE AND ADMINISTRATION)

DRUG DESCRIPTION

Cyclosporine, the active principle in Sandimmune^Ã? (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- a-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl- N-methyl-L-leucyl).

Sandimmune^Ã? 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, glycerol, Labrafil M 2125 CS (polyoxyethylated glycolysed glycerides), red iron oxide (25 mg and 100 mg capsule only), sorbitol, titanium dioxide, and other ingredients.

Sandimmune^Ã? 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^Ã? Injection (cyclosporine injection, USP) is available in a 5 mL sterile ampul for I.V. administration.

Each mL contains:

cyclosporine, USP ..........................................................................................................50 mg
*Cremophor^Ã? 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 before use.

The chemical structure of cyclosporine (also known as cyclosporin A) is