esium should also be monitored every 2 weeks for the first 3 months of therapy, and then monthly if the patient is stable or more frequently when dosage adjustments are made. Gengraf dosage should be reduced by 25%-50% for any abnormality of clinical concern.
In controlled trials of cyclosporine in psoriasis patients, cyclosporine blood concentrations did not correlate well with either improvement or with side effects such as renal dysfunction.
Information for Patients
Patients should be advised that any change of cyclosporine formulation should be made cautiously and only under physician supervision because it may result in the need for a change in dosage.
Patients should be informed of the necessity of repeated laboratory tests while they are receiving cyclosporine. Patients should be advised of the potential risks during pregnancy and informed of the increased risk of neoplasia. Patients should also be informed of the risk of hypertension and renal dysfunction.
Patients should be advised that during treatment with cyclosporine, vaccination may be less effective and the use of live attenuated vaccines should be avoided.
Patients should be given careful dosage instructions. Gengraf (cyclosporine oral solution, USP [MODIFIED]) should be diluted, preferably with orange or apple juice that is at room temperature. The combination of Gengraf with milk can be unpalatable. Patients should be advised to take Gengraf on a consistent schedule with regard to time of day and relation to meals. Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided.
Laboratory Tests
In all patients treated with cyclosporine, renal and liver functions should be assessed repeatedly by measurement of serum creatinine, BUN, serum bilirubin, and liver enzymes. Serum lipids, magnesium, and potassium should also be monitored. Cyclosporine blood concentrations should be routinely monitored in transplant patients (see DOSAGE AND ADMINISTRATION - Blood Concentration Monitoring in Transplant Patients), and periodically monitored in rheumatoid arthritis patients.
Drug Interactions
All of the individual drugs cited below are well substantiated to interact with cyclosporine. In addition, concomitant non-steroidal anti-inflammatory drugs, particularly in the setting of dehydration, may potentiate renal dysfunction.
Drugs That May Potentiate Renal Dysfunction
|
Antibiotics |
Antineoplastics |
Anti-inflammatory Drugs |
Gastrointestinal Agents |
|
ciprofloxacin |
melphalan |
azapropazon |
cimetidine |
|
gentamicin |
|
colchicine |
ranitidine |
|
tobramycin |
Antifungals |
diclofenac |
|
|
vancomycin |
amphotericin B |
naproxen |
Immunosuppressives |
|
trimethoprim with sulfamethoxazole |
ketoconazole |
sulindac |
tacrolimus |
|
|
|
|
|
|
|
|
|
