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Sandimmune

"Below is a list of the most popular prescription drugs dispensed in 2011 with links to drug monographs. The list may include the medication brand name and generic name.

Note: This information pertains to U.S. prescriptions only./"...

Sandimmune

Sandimmune® Soft Gelatin Capsules
(cyclosporine capsules, USP)

Sandimmune® Oral Solution
(cyclosporine oral solution, USP)

Sandimmune® Injection
(cyclosporine injection, USP)

WARNING

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune® (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® (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® Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune® Oral Solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED.

Sandimmune® and Neoral® are not bioequivalent and cannot be used interchangeably without physician supervision.

The absorption of cyclosporine during chronic administration of Sandimmune® 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 concentrations and subsequent dose adjustments be made in order to avoid toxicity due to high concentrations 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 concentrations of cyclosporine. Comparison of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed. (See Blood Concentration Monitoring under DOSAGE AND ADMINISTRATION.)

DRUG DESCRIPTION

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-leucylN-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyrylN-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 I.V. 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 before use.

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

Sandimmune® (cyclosporine capsules, USP)  Structural Formula Illustration

What are the possible side effects of cyclosporine (Gengraf, Neoral, Sandimmune)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, sweating, chills, body aches, flu symptoms, sores in your mouth and throat, weight loss;
  • change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);
  • easy bruising or bleeding, pale skin, confusion or weakness;
  • feeling light-headed...

Read All Potential Side Effects and See Pictures of Sandimmune »

What are the precautions when taking cyclosporine (Sandimmune)?

Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of chicken pox/shingles, uncontrolled high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy (including phototherapy with PUVA or UVB), kidney problems (for arthritis or psoriasis patients only).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver...

Read All Potential Precautions of Sandimmune »

Last reviewed on RxList: 5/17/2013
This monograph has been modified to include the generic and brand name in many instances.

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Sandimmune - User Reviews

Sandimmune User Reviews

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