SANDIMMUNE (Brand for CYCLOSPORINE)

Cyclosporine 100mg/1mL, Oral solution

High Fat Foods

· Severity: Major

· Notes for Consumers: It is important to take Cyclosporine consistently with or without food. The Sandimmune brand is affected by food more than other brands of Cyclosporine; although all can be affected to some degree. Grapefruit juice can increase the amount of Cyclosporine your body absorbs. If possible patients should avoid grapefruit or grapefruit juice while taking Cyclosporine. At the very least, patients receiving Cyclosporine should avoid large changes (i.e., either increases or decreases) in their daily intake of grapefruit and grapefruit juice. Do not mix cyclosporine oral solution with grapefruit juice.

· Notes for Professionals: The oral bioavailability of non-modified cyclosporine is highly variable and food interactions are possible. Administration with high-fat content meals increases both bioavailability and clearance; however, the AUC does not change significantly. In general, food will decrease the absorption of modified cyclosporine. It is important to take cyclosporine consistently with or without food to ensure uniform cyclosporine concentrations.

Cyclosporine 100mg/1mL, Oral solution

Alcohol

· Severity: Mild

· Notes for Consumers: Although it is probably not related to the alcohol content of the wine, red wine may decrease the levels of Cyclosporine in your blood. If you have received an organ transplant and take Cyclosporine, drinking red wine could increase the risk of organ rejection. If you notice increased tiredness or other symptoms, notify your prescriber right away.

· Notes for Professionals: Although the effects probably do not involve the ethanol content of red wine, in vitro data suggest that red wine may increase the oral clearance of cyclosporine (Non-modified). It should be noted that these results may not extrapolate to cyclosporine (Modified) formulations.

Cyclosporine 100mg/1mL, Oral solution

Grapefruit juice

· Severity: Major

· Notes for Consumers: Grapefruit juice can increase the amount of Cyclosporine your body absorbs and increase the risk of Cyclosporine side effects. If possible patients should avoid grapefruit or grapefruit juice while taking Cyclosporine. At the very least, patients receiving Cyclosporine should avoid large changes (i.e., either increases or decreases) in their daily intake of grapefruit juice. Do not mix cyclosporine oral solution with grapefruit juice.

· Notes for Professionals: Grapefruit juice inhibits the enterocyte CYP3A4 isoenzyme and increases cyclosporine serum concentrations. Thus, grapefruit and grapefruit juice consumption by patients receiving cyclosporine should be avoided. Grapefruit juice contains compounds that can inhibit P-450 isozymes and the p-glycoproteins lining the intestinal wall. Administration of either formulation of cyclosporine with grapefruit juice significantly increased cyclosporine concentrations and AUC compared to administration with either orange juice or water. Separating dose of grapefruit juice from cyclosporine may not eliminate the interaction completely, as the inhibitory effect of grapefruit juice can last for several hours. Patients stabilized on cyclosporine should avoid large changes (i.e., either increases or decreases) in their daily intake of grapefruit juice. Do not mix cyclosporine oral solution with grapefruit juice.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>