GENGRAF (Generic for NEORAL)

Cyclosporine, Modified 25mg, Oral capsule

Alcohol

· Severity: Major

· Notes for Consumers: Some forms of this medication may have other interactions. Discuss the form you are taking with your care team. Drinking alcohol may alter the effects of your medication. Serious side effects may occur. Contact your care team if you experience new or worsening side effects.

· Notes for Professionals: Advise patients to avoid consuming red wine with cyclosporine. In a healthy volunteer study involving non-modified cyclosporine, consuming red wine while taking cyclosporine decreased cyclosporine peak and overall exposure by 38% and 30% respectively. The effect of other forms of alcohol and the impact to modified cyclosporine dosage forms in unknown.

Cyclosporine, Modified 25mg, Oral capsule

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.

Cyclosporine, Modified 25mg, Oral capsule

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.

<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>