Mycophenolate Fetal Toxicity and Risk Evaluation and Mitigation Strategies

Kim, M.; Rostas, Sara E.; Gabardi, Steven

doi:10.1111/ajt.12238

Cited by 74 publications

(61 citation statements)

References 21 publications

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“…Th e potential for impaired wound healing with everolimus and sirolimus must be considered if cesarean section is performed (193)(194)(195)(196). It is clear that mycophenolic acid should not be used during pregnancy owing to risk of congenital malformations and embryo-fetal toxicity (197)(198)(199)(200).…”

Section: Primary Biliary Cirrhosismentioning

confidence: 99%

ACG Clinical Guideline: Liver Disease and Pregnancy

Tran

Ahn

Reau

2016

American Journal of Gastroenterology

237

257

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Consultation for liver disease in pregnant women is a common and oftentimes vexing clinical consultation for the gastroenterologist. The challenge lies in the need to consider the safety of both the expectant mother and the unborn fetus in the clinical management decisions. This practice guideline provides an evidence-based approach to common diagnostic and treatment challenges of liver disease in pregnant women. Am J Gastroenterol 2016; 111:176-194; doi: 10.1038/ajg.2015 Initial evaluation of pregnant patientA pregnant patient presenting with abnormal liver tests should undergo standard workup as with any non-pregnant individual (strong recommendation, very low level of evidence). Imaging in pregnancyUltrasound is safe and the preferred imaging modality used in assessment of abnormal liver tests suggestive of biliary tract disease (strong recommendation, low level of evidence).Magnetic resonance imaging without gadolinium can be used in the second and third trimester (conditional recommendation, low level of evidence).Computed tomography scans carry a risk of teratogenesis and childhood hematologic malignancies but may be used judiciously with minimized radiation protocols (2-5 rads; conditional recommendation, very low level of evidence). Endoscopy in pregnancyEndoscopy is safe in pregnancy but should be deferred until the second trimester if possible (strong recommendation, low level of evidence).Meperidine and propofol can be used for endoscopic sedation (strong recommendation, moderate level of evidence). Management of biliary disease in pregnancyERCP can be performed when indicated for pregnant women presenting with biliary disease that strongly necessitates intervention such as biliary pancreatitis, symptomatic choledocholithiasis, and/or cholangitis. Minimizing fetal exposure to fl uoroscopy is imperative (strong recommendation, low level of evidence).Symptomatic cholecystitis should be managed with early surgical intervention with laparoscopic cholecystectomy (strong recommendation, low level of evidence). Liver masses in pregnancyAsymptomatic hemangioma and focal nodular hyperplasia do not need routine imaging or surveillance during pregnancy (strong recommendation, very low level evidence).Hepatic adenomas should be monitored with ultrasound during pregnancy for growth. Patients with large adenomas (>5 cm) should be referred for resection prior to pregnancy (strong recommendation, low level of evidence). Hepatitis B in pregnancyActive-passive immunoprophylaxis with hepatitis B immunoglobulin and the HBV vaccination series should be administered to all infants born to HBV-infected mothers to prevent perinatal transmission (strong recommendation, low level of evidence).Women chronically infected with HBV and high viral load (>10 6 log copies/ml (200,000 IU/ml) and higher) should be offered antiviral medication with tenofovir or telbivudine in the third trimester to reduce perinatal transmission of HBV (strong recommendation, low level of evidence).C-section should not be performed electively in HBV-pos...

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Section: Primary Biliary Cirrhosismentioning

confidence: 99%

ACG Clinical Guideline: Liver Disease and Pregnancy

Tran

Ahn

Reau

2016

American Journal of Gastroenterology

237

257

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“…The most important exception is mycophenolic acid that is associated with increased risk of both miscarriage and congenital birth defects and should be discontinued before conception and replaced with an alternative medication (3,4). However, transplanted males are not advised to discontinue treatment with mycophenolic acid before conception.…”

Section: Pregnancies Fathered By Transplanted Malesmentioning

confidence: 99%

“…The outcomes of these pregnancies of immunosuppressed female organ transplant patients have been studied primarily with registry data from voluntary registries of pregnancies among solid organ transplant patients. Current data indicate that the risk of congenital malformation is similar to that of the general female population for most immunosuppressive medications (2,3), except mycophenolic acid, where an increased rate of birth defects (of approximately 24%) in fetuses has been reported (3,4). Thus, mycophenolic acid is contraindicated in transplanted females just prior to and during pregnancy.…”

Section: Introductionmentioning

confidence: 99%

Obstetric and Neonatal Outcome of Pregnancies Fathered by Males on Immunosuppression After Solid Organ Transplantation

Morken

Díaz-García

Reisæter

et al. 2015

American Journal of Transplantation

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Immunosuppressive drugs may influence spermatogenesis, but little is known about outcome of pregnancies fathered by transplanted males. We estimated risk of adverse outcomes in pregnancies (with data after the first trimester) fathered by males that had undergone organ transplantation and were treated with immunosuppression. A population-based study, linking data from the Norwegian transplant registry and the Medical Birth Registry of Norway during 1967-2009 was designed. All Norwegian men undergoing solid organ transplantation were included. Odds ratios for major malformations, preeclampsia, preterm delivery (<37 weeks) and small-for-gestational-age were obtained using logistic regression. A total of 2463 transplanted males, fathering babies of 4614 deliveries before and 474 deliveries after transplantation were identified. The risk of preeclampsia was increased (AOR: 7.4, 95% CI: 1.1-51.4,) after transplantation compared to prior to transplantation. No increased risk was found for congenital malformations or other outcomes when compared with pregnancies before transplantation or with the general population (2 511 506 births). Our results indicate an increased risk of preeclampsia mediated through the transplanted and immunosuppressed father. Importantly, no increased risk was found for other adverse obstetric outcomes or malformations, which may reassure male transplant recipients planning to father children.

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“…[98][99][100][101] A toxicidade ocorreu predominantemente com exposições durante o primeiro trimestre de gestação e é dose-dependente. Há poucos dados sobre a exposição ao micofenolato de mofetilo em fases mais tardias da gravidez, mas pode resultar em alterações hematológicas nos recém--nascidos.…”

Section: Micofenolato De Mofetilo (Categoria De Risco D Pela Fda)unclassified

Gravidez, Aleitamento e Fármacos em Dermatologia - Tratamento Sistémico

Cesar

Azevedo

Mota

2016

SPDV

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RESUMO -O crescente número de fármacos empregues na prática dermatológica e venereológica exige do dermatologista um conhecimento atualizado relativo à sua segurança. No caso particular de mulheres grávidas ou que amamentem, a decisão sobre se se deve ou não tratar com um determinado fármaco deve basear-se numa avaliação ponderada dos benefícios para a saúde materna e dos riscos potenciais para o bem-estar fetal ou do lactente. Quando estas doentes necessitam terapêuticas tópicas ou sistémicas, a maioria pode ser adequadamente tratada com opções consideradas seguras e eficazes. Na primeira parte deste artigo são abordados os dados mais recentes relativos à segurança de alguns dos medicamentos sisté-micos mais comummente usados em contexto dermatológico, na mulher em idade fértil. PALAVRAS-CHAVE -Agentes Dermatológicos/uso terapêutico; Aleitamento/efeito dos medicamentos; Complicações na Gravidez/quimioterapia; Doenças da Pele/quimioterapia; Doenças de Pele/tratamento; Gravidez. Pregnancy, Lactation and Drugs in DermatologySystemic Therapy ABSTRACT -The increasing number of drugs used in dermatological a venereological practice demands from the dermatologist INTRODUÇÃOAo tratar doentes grávidas ou durante o período de aleitamento é fundamental um conhecimento dos potenciais efeitos adversos dos medicamentos sobre o desenvolvimento do feto ou do lactente. O risco de teratogenicidade e a capacidade de cada fármaco ser excretado no leite materno permite, na maioria das ocasiões, optar por alternativas seguras no tratamento de doenças do foro dermatológico em mulheres durante o período gestacional e durante a amamentação.Este artigo de revisão tem por objetivo abordar os dados disponíveis referentes à segurança (ou falta dela) de alguns dos fármacos mais comummente prescritos em contexto dermatológico e venereológico nas mulheres em idade fér-til. A primeira parte deste artigo aborda os fármacos administrados por via sistémica e a segunda parte irá abordar os fármacos de aplicação local. Corticosteróides sistémicos (categoria de risco C pela Food Drug Administration -FDA)A dexametasona e a betametasona não sofrem metabolização placentária significativa, passando inalterados através da placenta.1 Já a prednisolona sofre conversão em metabolitos inativos pela placenta humana, o que limita a sua passagem para o embrião/feto, pelo que é a opção

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Mycophenolate Fetal Toxicity and Risk Evaluation and Mitigation Strategies

Cited by 74 publications

References 21 publications

ACG Clinical Guideline: Liver Disease and Pregnancy

ACG Clinical Guideline: Liver Disease and Pregnancy

Obstetric and Neonatal Outcome of Pregnancies Fathered by Males on Immunosuppression After Solid Organ Transplantation

Gravidez, Aleitamento e Fármacos em Dermatologia - Tratamento Sistémico

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