Mofecon-C 250/Mofecon 500 Special Precautions

Blood and immune system: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate in combination with other immunosuppressive agents. The mechanism for mycophenolate mofetil induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppression regimen are also unknown. In some cases PRCA was found to be reversible with dose reduction or cessation of therapy. In transplant patients however reduced immunosuppression may place the graft at risk.
Patients receiving Mofecon-C 250/Mofecon 500 should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. Patients on Mofecon-C 250/Mofecon 500 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 Mofecon-C 250/Mofecon 500 should be monitored for neutropenia. The development of neutropenia may be related to Mofecon-C 250/Mofecon 500, concomitant medications, viral infection or some combination of these causes. If neutropenia develops (absolute neutrophil count <1.3 x 10³/mcL), dosing with Mofecon-C 250/Mofecon 500 should be interrupted or the dose should be reduced and the patient carefully observed.
Vaccination: Patients should be advised that during treatment with Mofecon-C 250/Mofecon 500 vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see Interactions). Influenza vaccination may be of value. Prescribers should refer to national guidelines for influenza vaccination.
Gastro-intestinal: Mofecon-C 250/Mofecon 500 has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation. Mofecon-C 250/Mofecon 500 should be administered with caution in patients with active digestive system disease.
Mofecon-C 250/Mofecon 500 is an inosine monophosphate dehydrogenase (IMPDH) inhibitor; therefore it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Infection: Risk for bacterial, viral, fungal, and protozoal infections including opportunistic infections is increased with immunosuppressant therapy; infections may be serious and potentially fatal. Polyomavirus associated nephropathy (PVAN), JC virus-associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV), have been reported with use.
Neoplasms: Risk of development of lymphoma and skin malignancy is increased.
Interaction: Caution should be exercised when swathing combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation e.g. ciclosporin to others devoid of this effect e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure. Therapeutic drug monitoring of MPA may be appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, treatment with antibiotics, addition or removal of an interacting medication).
Drug which interfere with MPA's enterohepatic cycle (e.g. cholestyramine, sevelamer, antibiotics) should be used with caution due to their potential to reduce the plasma levels and efficacy of Mofecon-C 250/Mofecon 500. Sevelamer and other calcium free phosphate binders should be taken 2 hours after Mofecon-C 250/Mofecon 500 intake to minimize the impact on the absorption of MPA.
It is recommended that Mofecon-C 250/Mofecon 500 should not be administered concomitantly with azathioprine because both have the potential to cause bone marrow suppression and such concomitant administration has not been studied.
Renal function impairment: Avoid doses of more than 1 g of mycophenolate twice daily in renal transplant patients and carefully observe these patients.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Mycophenolate may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
Use in Pregnancy & Lactation: Mycophenolate is associated with an increased risk of congenital malformations and first trimester pregnancy loss when used by pregnant women. Females of reproductive potential must be counseled about pregnancy prevention and planning. Acceptable forms of contraception should be used during treatment and for 6 weeks after therapy is discontinued.
It is not known if mycophenolate is excreted in human milk. Breastfeeding is not recommended during therapy or for 6 weeks after treatment is complete.
Mofecon-C 250/Mofecon 500 is contraindicated in pregnancy and during breastfeeding.
Use in Children: Safety and efficacy in pediatric patients receiving allogeneic cardiac or hepatic transplants, or in renal transplant patients younger than 3 months have not been established.
Use in the Elderly: Use caution in dosage selection for an elderly patient, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant or other drug therapy. Elderly patients may be at an increased risk of adverse reactions compared with younger individuals.