The purpose of this study was to describe pregnancy outcomes with exposure to sirolimus. Data were collected by the National Transplantation Pregnancy Registry (NTPR) via questionnaires, phone interview and hospital records. There are currently 1,253 female recipients reporting 2,188 pregnancies to the NTPR. Of these, there were 26 transplant recipients (16 kidney, 5 liver, 4 heart, and 1 pancreas-kidney) reporting 30 pregnancies with exposure to sirolimus during pregnancy. There were 19 live births (LB) and 11 spontaneous abortions (SA). Of these, there were 7 LB and 5 SA with concomitant mycophenolic acid product exposure (MPA), and 12 LB, 5 SA, and 1 therapeutic abortion without MPA exposure. Four of the pregnancies were reported being planned, while 26 were reported as an unplanned pregnancy. Sirolimus was continued throughout the pregnancy in 11 cases, discontinued during pregnancy in 18, and started in the third trimester during 1 pregnancy. Two kidney recipients had rejection during pregnancy: in the first sirolimus, was stopped when the pregnancy was discovered and in the second, sirolimus was started late in pregnancy. Both recipients had graft loss; the first 1.8 years postpartum and the second during pregnancy. Among the 19 live births the incidence of prematurity was 47%. Two infants had birth defects: in one infant there were multiple malformations including cleft lip and palate and microtia (late exposure to sirolimus and early exposure to MPA) and Tetralogy of Fallot in the other. The remaining 17 children were reported healthy and developing well.

Conclusions: Successful pregnancy outcomes with exposure to sirolimus have been reported in various solid organ transplant recipients. Sirolimus exposure during pregnancy does not appear to be associated with an increased risk or a pattern of birth defects. As this is a limited data set, additional entries to the NTPR will assist in formulating definitive conclusions regarding sirolimus use during pregnancy.

Coscia, L.: Grant/Research Support, Novartis Pharmaceuticals Corp. Astellas Pharma US, Inc. Genentech, Inc. Pfizer Inc. Bristol-Myers Squibb, Sandoz and Teva. Zuckoff, A.: Grant/Research Support, Novartis Pharmaceuticals Corp. Astellas Pharma US, Inc. Genentech, Inc. Pfizer Inc. Bristol-Myers Squibb, Sandoz and Teva. Armenti, V.: Grant/Research Support, Novartis Pharmaceuticals Corp. Astellas Pharma US, Inc. Genentech, Inc. Pfizer Inc. Bristol-Myers Squibb, Sandoz and Teva.

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