Tacrolimus (all routes) - Medication and Pregnancy KB

Tacrolimus (all routes)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Al-Otaibi, 2019	Kuwait 2004 - 2017	Renal transplant recipients who became pregnant during the study period.	Pregnant women maintained on tacrolimus-based regimen (all patients also maintained on steroids plus azathioprine).	exposed to other treatment, sick Pregnant women maintained on cyclosporin-based regimen (all patients also maintained on steroids plus azathioprine).	33 / 49
Alvaro, 2013	Spain 1986 - 2011	Females with orthotopic liver transplantation who became pregnant during the study period.	Pregnant women with orthotopic liver transplantation using tacrolimus during pregnancy.	exposed to other treatment, sick Pregnant women with orthotopic liver transplantation using cyclosporine during pregnancy.	15 / 5	No mention of mycophenomate mofetil.
Ichinose, 2018	Japan 2008 - 2016	Patients with systemic lupus erythematosus who had deliveries during the study period who were admitted to the study centers.	Mothers with systemic lupus erythematosus treated with tacrolimus during the pregnancy.	unexposed, sick Mothers with systemic lupus erythematosus never treated with tacrolimus during pregnancy.	15 / 39	The patients for whom tacrolimus treatment was terminated during a pregnancy were excluded.
Kim, 2015	Seoul, Korea 1991 - 2012	All women who delivered babies after having undergone kidney transplantation at those hospitals between the study period.	Deliveries given tacrolimus-based immunosuppressants mostly combined with azathioprine and/or steroids (prednisolone or methylprednisolone).	exposed to other treatment, sick Deliveries given cyclosporine-based immunosuppressants mostly combined with azathioprine and/or steroids (prednisolone or methylprednisolone).	28 / 60	None of the pregnancies were exposed to mycophenolic acid.
Perales-Puchalt, 2012	Valencia, Spain 1995 - 2009	Pregnancies occurred in patients with normal functioning kidney transplants from deceased donors.	Immunosuppressive drugs used was Tacrolimus. All patients used Prednisone as a co-adjuvant therapy. The treatment protocol of the patients remained unchanged during the study period.	exposed to other treatment, sick Immunosuppressive drugs used were Cyclosporine-A and four had a combination with Azathioprine. All patients used Prednisone as a co-adjuvant therapy. The treatment protocol of the patients remained unchanged during the study period.	9 / 11	Cyclosporine-A (CsA) and Azathioprine (AZA) groups could not be add because four pregnancies had a combination of CsA and AZA. Combinations are detailed and no mycophenolate mofetil involved.
Thompson, 2003	England 1976 - 2001	All pregnancies in the institute's renal transplant recipients	Pregnant transplanted patients under tacrolimus, prednisolone and azathioprine.	exposed to other treatment, sick Pregnant transplanted patients under prednisolone, azathioprine -based regimens, with or without cyclosporine.	4 / 23	No mycophenolate mofetil.
Wielgos, 2012	Poland 2005 - 2010	Women with renal or liver transplantation, who had delivered during the study period.	Pregnant women who underwent renal or liver transplantation treated with tacrolimus-based regimen (alone or with prednisolone and/or azathioprine).	exposed to other treatment, sick Pregnant women who underwent renal or liver transplantation treated with cyclosporine-based regimen (alone or with prednisolone and/or azathioprine)..	21 / 9	Data of patients treated with tacrolimus who underwent both renal and liver transplantation were added. None of women were treated with mycophenolate mofetil nor sirolimus during the time of pregnancy.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Sugawara, 2019	Japan 2007 - 2016	Pregnant women with any maternal and/or fetal complications.	Pregnant women without any maternal and/or fetal complications.	34 / 23	Maternal adverse events: 34 cases and 23 controls. Fetal adverse events: 27 cases and 30 controls. Authors made some comparison with general obstetric population in Japan (GOP), but there is no distinction between treatments (results not reported here).

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