Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Myclausen

Myclausen 250 mg hard capsules · Abschnitt 4.8 · PDF-Seite 31–32

HOS-212990 · Präparat HOS-155006

Blood and lymphatic disorders Cytopenias, including leukopenia, anemia, thrombocytopenia and pancytopenia, are known risks associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and hemorrhages (see section 4.4). Agranulocytosis and neutropenia have been reported; therefore, regular monitoring of patients taking mycophenolate mofetil is advised (see section 4.4). There have been 31 reports of aplastic anaemia and bone marrow failure in patients treated with mycophenolate mofetil, some of which have been fatal. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (see section 4.4). Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with mycophenolate mofetil. These changes are not associated with impaired neutrophil function. These changes may suggest a ‘left shift’ in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive mycophenolate mofetil.

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