Table 2. Series reports with exposure to mycophenolate.

Reference and cases reported in the reference	Age and Indication	MPA product exposurea	Concomitant immunosuppression	Concomitant medications	Pregnancy outcome	Birth defects
Ortiz et al (2009)60	5 mothers 5 pregnancies SLE	Mean daily dose 1.5 daily	Prednisone (5)	Hydroxychloroquine (4), alendronate (3), benazepril (1)	3 LB 2 M	None
Klieger-Grossmann et al (2010)50	10 mothers 11 pregnancies				4 M (36%) 6 LB 1 TOP	1 (17%)
1	42 y kidney transplant	750 daily	Not reported	Not reported	LB 40 wk 2,900 g	None
2	36 y SLE	250 BID wk 8–13	Not reported	Not reported	LB 37 wk 2,850 g	None
3	29 y SLE	500 daily until wk 5	Not reported	Not reported	M 8 wk
4	27 y SLE	500 BID	Not reported	Not reported	TOP 12 wk
5	24 y SLE	500 BID	Not reported	Not reported	M 8 wk
	32 y SLE	500 BID	Not reported	Not reported	M 12 wk
6	34 y kidney transplant	500 BID until wk 6	Not reported	Not reported	LB 36 wk 2,900 g	None
7	32 y autoimmune	500 BID until wk 12	Not reported	Not reported	M 13 wk
8	39 y kidney transplant	500 BID until wk 6	Not reported	Not reported	LB 37 wk 2,375 g	None
9	26 y rheumatoid arthritis	500 daily until wk 7	Not reported	Not reported	LB 42 wk 2,960 g	None
10	Unknown	500 BID until wk 12	Not reported	Not reported	LB	Microtia with hearing loss
Hoeltzenbein et al (2012)12	57 pregnancies Organ transplant (22) SLE (23) Other autoimmune disorders (12)				16 M (28%) 29 LB 12 TOP	8 malformations 6 LB (21%) 2 TOP due to malformations
1	SLE	1,000 BID	Prednisone	Hydroxychloroquine, perindopril	TOP 25 wk	See Table 1 (case report by El Sebaaly et al)39
2	SLE	750 daily until wk 8	Prednisone, azathioprine	Enalapril, hydroxychloroquine, alendronate, acetylsalicylic acid	TOP 23 wk	Microtia, external ear canal atresia, colobomal cyst, olfactory nerve agenesis, hypertelorism, malar hypoplasia, brachycephaly, microretrognathia, esophageal atresia type III, retroesophageal right subclavian artery, campto-/clinodactylia
3	Kidney transplant	500 daily	Tacrolimus, prednisone	Acebutolol	LB 41 wk	Microtia, external auditory canal atresia, begin cyst right kidney
4	SLE	500 daily until 10 wk	None reported	Escitalopram, lorazepam, zolpidem	LB 35 wk	Tracheoesophageal atresia type 3
5	Kidney transplant	Unknown dose until 8 wk and 25–36 wk	Tacrolimus, azathioprine, prednisone	Fosfomycin (wk 14)	LB 36 wk	Hydronephrosis (surgery at 8 mo), autism (diagnosis at age 3 y)
6	Liver transplant	1,000 daily until 18 wk	Cyclosporine, prednisone	Ursodeoxycholic acid	LB 31 wk	Atrial septal defect type II, asymmetry of brain ventricles, prematurity complications
7	Hyper IgD syndrome	1,440 daily (EC-MPS) until 5 wk	Prednisolone	abatacept, naproxen, colchicine, valacyclovir	LB 35 wk	Occipital meningocele, dysplastic left cerebellar hemisphere
8	Unknown	Unknown dose until 8 wk	Azathioprine, prednisone	Methyldopa	LB 36 wk	External auditory canal atresia
NTPR (2013)51	Heart transplant: 15 recipients 23 pregnancies 25 outcomes	Various doses in early pregnancy	Most on a calcineurin inhibitor ± prednisone	Not reported	16 M (64%) 9 LB	3 (33%) facial defects (1), laryngomalacia (1), duodenal atresia, tetralogy of Fallot, atrioventricular canal defect (1)
NTPR (2013)55	Kidney transplant: 114 recipients 115 pregnancies outcomes	Various doses in early pregnancy	Most on a calcineurin inhibitor ± prednisone	Not reported	60 M (52%) 50 LB 3 TOP 2 S	7 (14%); 1 stillbirth with cranial anomalies, solitary kidney and webbed fingers (not included in birth defect percentage)
	Case 1	Dose unknown throughout pregnancy	Tacrolimus and prednisone	Cyclosporine and prednisone	LB 37 wk 2,722 g	Mild pulmonary valve stenosis
	Case 2	500 BID switched to sirolimus at 24 wk	Tacrolimus and prednisone	Labetalol, lansoprazole	LBb 31 wk 1,531 g	Large left sided cleft lip and palate and bilateral microtia and external auditory canal atresia
	Case 3	1,000 BID until 16 wk	Tacrolimus and prednisone		LB 38 wk 3,118 g	Microtia type III
	Case 4c	250 BID	Tacrolimus 5 daily Prednisone 5 daily	Amlodipine, metoprolol, furosemide, erythropoietin, acyclovir (1st mo)	LBb 35 wk 2,163 g; neonatal death on day 2	See Table 1 (case report by Parisi et al32)
	Case 5c	250 BID until 11 wk	Tacrolimus, prednisone, azathioprine		LB 35 wk 2,551 g	Microtia, syndactyly (family history)
	Case 6	720 BID (EC-MPS) decreased 360 BID at 12 wk	Tacrolimus and prednisone	Thyroxin, metoprolol	LB 36 wk 2,041 g	Diaphragmatic hernia, right lung not developed, neonatal death
	Case 7	500 BID until 4 wk	Tacrolimus and prednisone	Labetalol, Coumadin switch to enoxaparin sodium	LB 34 wk 1,758 g	Ventricular septal defect
Mohamed-Ahmed et al (2014)53	Liver transplant: 7 pregnancies, Heart transplant: 2 pregnancies	500–2,000 daily (3 continued throughout pregnancy)	Not reported	Not reported	“Good fetal outcome” (2) “Poor fetal outcome”d (7)	Not reported

Abbreviations: BID, mg twice a day; LB, live birth; M, miscarriage; MPA, mycophenolic acid; QOD, every other day; S, stillbirth; SLE, systemic lupus erythematosus; TID, three times a day; TOP, termination of pregnancy.

Note: Unless noted, medication was continued throughout pregnancy.

^aWk denotes gestational age in weeks.

^bNormal karyotype noted in report.

^cMay overlap with NTPR.

^dPoor fetal outcome defined as stillbirth, miscarriage, very low birth weight (<1,500 g), small for gestational age (<10th%), congenital anomaly, admission to neonatal unit, very preterm.