Myfortic Adverse Reactions

The following undesirable effects cover adverse drug reactions from clinical trials: Malignancies: Patients receiving immunosuppressive regimens involving combinations of drugs, including MPA, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see Precautions). Lymphoproliferative disease or lymphoma developed in 2 de novo (0.9%) patients and in 2 maintenance patients (1.3%) receiving Myfortic for up to 1 year. Non-melanoma skin carcinomas occurred in 0.9% of de novo and 1.8% of maintenance patients receiving Myfortic for up to 1 year; other types of malignancy occurred in 0.5% of de novo and 0.6% of maintenance patients.
Opportunistic infections: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see Precautions). The most common opportunistic infections in de novo renal transplant patients receiving Myfortic with other immunosuppressants in controlled clinical trials of renal transplant patients followed for 1 year were cytomegalovirus (CMV), candidiasis and herpes simplex. CMV infection (serology, viraemia or disease) was reported in 21.6% of de novo and in 1.9% of maintenance renal transplant patients.
Older people: Elderly patients may generally be at increased risk of adverse drug reactions due to immunosuppression.
Other adverse drug reactions: Table 2 as follows contains adverse drug reactions possibly or probably related to Myfortic reported in the controlled clinical trials in renal transplant patients, in which Myfortic was administered together with ciclosporin microemulsion and corticosteroids at a dose of 1,440 mg/day for 12 months. It is compiled according to MedDRA system organ class. (See Table 2).
Adverse reactions are listed according to the following categories: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).

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Rash and agranulocytosis have been identified as adverse drug reactions from post marketing experience.
The following additional adverse reactions are attributed to MPA derivatives as a class effect: Infections and infestations: Serious, life-threatening infections, including meningitis, infectious endocarditis, tuberculosis, and atypical mycobacterial infection. Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Myfortic (see Precautions).
Blood and lymphatic system disorders: Neutropenia, pancytopenia.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives (see Precautions).
Immune system disorders: Hypogammaglobulinaemia has been reported in patients receiving Myfortic in combination with other immunosuppressants.
Respiratory, thoracic and mediastinal disorders: There have been isolated reports of interstitial lung disease in patients treated with Myfortic in combination with other immunosuppressants. There have also been reports of bronchiectasis in combination with other immunosuppressants.
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with MPA derivatives. 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 Myfortic.
Gastrointestinal disorders: Colitis, CMV gastritis, intestinal perforation, gastric ulcers, duodenal ulcers.
Pregnancy, puerperium and perinatal conditions: Cases of spontaneous abortion have been reported in patients exposed to mycophenolate mainly in the first trimester (see Use in Pregnancy & Lactation).
Congenital disorders: Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate in combination with other immunosuppressants (see Use in Pregnancy & Lactation).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.