Refrat Special Precautions

Immunosuppressed patients are at increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus associated nephropathy which has been observed in patients receiving immunosuppresants. These infections may lead to serious, including fatal outcomes.
As in all patients receiving immunosuppressive regimens involving combinations of drugs, patients receiving Mycophenolate mofetil as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As with all patients at an increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sun screen with a high protection factor.
Patients receiving mycophenolate mofetil tablets should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Patients should be advised that during treatment with mycophenolate mofetil, vaccinations may be less effective and the use of live attenuated vaccines should be avoided.
Because mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation, Mycophenolate mofetil should be administered with caution in patients with active digestive system disease.
Because mycophenolate mofetil is an inosine monophosphate dehydrogenase (IMPDH) inhibitor, on theoretical grounds it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seeg-miller syndrome.
It is recommended that mycophenolate mofetil should not be administered concomitantly with azathioprine because both have the potential to cause bone marrow suppression and such concomitant administered has not been studied.
In view of the significant reduction in the AUC of MPA by cholestyramine, caution should be used in concomitant administration of mycophenolate mofetil with drugs that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of mycophenolate mofetil.
Administration of doses greater than 1 g twice daily to renal patients with severe chronic renal impairment should be avoided. No dose adjustment is recommended for post transplant patients with delayed renal graft function, but patients should be carefully monitored. No data are available for cardiac or hepatic transplant patients with severe renal impairment. Elderly patients may be at increased risk of adverse events compared with younger individuals.
Laboratory monitoring: Patients on Mycophenolate mofetil should have complete blood counts weekly during the first month of treatment, twice monthly for the second and third months, then monthly through the first year. In particular, patients receiving Mycophenolate mofetil should be monitored for neutropenia. The development of neutropenia may be related to Mycophenolate mofetil, concomitant medications, viral infection or some combination of these causes. If neutropenia develops (absolute neutrophil count <1.3x10³/μL), dosing with Mycophenolate mofetil should be interrupted or the dose reduced and the patient should be carefully observed.