Exposure to Mycophenolate and Fatherhood.

Background: Mycophenolic acid (MPA) is the active immunosuppressive substance in both mycophenolate mofetil and mycophenolate sodium and it is widely used after organ transplantation. In females taking MPA is teratogenic and may also influence spermatogenesis. There is a lack of knowledge regarding outcome of pregnancies fathered by males exposed to MPA. Methods: We compared outcomes in pregnancies fathered by renal transplant males per whether they had been exposed to MPA or not at time of conception. A nation-wide population-based retrospective cohort study was performed. Data from the Norwegian Renal Registry with all renal transplanted men alive between Jan. 1st 1995 and Dec. 31st 2015 were included and relevant outcome data were extracted from the Medical Birth Registry of Norway. Results: During the given time, 230 immunosuppressed renal transplanted males fathered 350 children (155 on MPA/195 not on MPA). There were no significant increased risk of malformation (3.9% vs 2.6%, P=0.49) in MPA exposed vs unexposed cohorts of children. The average dose (+/-SD) of mycophenolate was 1.42 +/- 0.3 g/day and the individual median MPA trough concentration in the time period of anticipated conception and pregnancy was 2.8 +/- 1.6 mg/L. Birth weight was similar in exposed and unexposed cohorts of children; 3381+/-681 grams vs. 3429 +/-714 grams (P=0.53). Conclusions: Paternal exposure to MPA did not increase the risk of adverse birth outcomes in children fathered by male kidney transplanted patients. These results are reassuring and support the continuation of paternal MPA treatment before, during and after conception. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Copyright (C) 2017 Wolters Kluwer Health, Inc. All rights reserved.

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