Mycophenolate fetal toxicity and risk evaluation and mitigation strategies

American Journal of Transplantation

Volumn 13, Issue 6, 2013, Pages 1383-1389

  Kim, M ^a   Rostas, S ^a   Gabardi, S ^a,b  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Enteric coated mycophenolic acid; mycophenolate mofetil; mycophenolic acid; REMS; risk evaluation and mitigation strategies

Indexed keywords

ETHINYLESTRADIOL; ETONOGESTREL; LEVONORGESTREL; MYCOPHENOLIC ACID;

AUTOIMMUNE DISEASE; BIRTH DEFECT; BONE MARROW SUPPRESSION; CLINICAL PRACTICE; CONGENITAL MALFORMATION; DRUG APPROVAL; DRUG CONTRAINDICATION; FETOTOXICITY; FETUS RISK; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; HUMAN; INFORMED CONSENT; MEDICAL EDUCATION; PRACTICE GUIDELINE; PREGNANCY; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; SPONTANEOUS ABORTION;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; FEMALE; FETAL DISEASES; FETUS; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INCIDENCE; MYCOPHENOLIC ACID; ORGAN TRANSPLANTATION; PRACTICE GUIDELINES AS TOPIC; PREGNANCY; PREGNANCY COMPLICATIONS; RISK MANAGEMENT; UNITED STATES;

EID: 84878516236     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/ajt.12238     Document Type: Review

References (36)

1. Ransom JT., Mechanism of action of mycophenolate mofetil. Ther Drug Monit 1995; 17: 681-684.
2. Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. 2013. Available at: http://www.accessdata.fda.gov/scripts/cder/ob/ default.cfm. Accessed October 11, 2013.
3. Knight SR, Russell NK, Barcena L, Morris PJ., Mycophenolate mofetil decreases acute rejection and may improve graft survival in renal transplant recipients when compared with azathioprine: A systematic review. Transplantation 2009; 87: 785-794.
4. Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. European mycophenolate mofetil cooperative study group. Lancet 1995; 345: 1321-1325.
5. Sollinger HW., Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. US renal transplant mycophenolate mofetil study group. Transplantation 1995; 60: 225-232.
6. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. The tricontinental mycophenolate mofetil renal transplantation study group. Transplantation 1996; 61: 1029-1037.
7. Barraclough KA, Staatz CE, Isbel NM, Johnson DW., Therapeutic monitoring of mycophenolate in transplantation: Is it justified ? Curr Drug Metab 2009; 10: 179-187.
8. Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients 2010 data report. Am J Transplant 2012; 12: 1-156.
9. Jungraithmayr TC, Wiesmayr S, Staskewitz A, et al. Five-year outcome in pediatric patients with mycophenolate mofetil-based renal transplantation. Transplantation 2007; 83: 900-905.
10. Zachariah MS, Tornatore KM, Venuto RC., Kidney transplantation and pregnancy. Curr Opin Organ Transplant 2009; 14: 386-391.
11. Coscia LA, Constantinescu S, Moritz MJ, et al. Report from the National Transplantation Pregnancy Registry (NTPR): Outcomes of pregnancy after transplantation. Clin Transpl 2007; 29-42.
12. Sifontis NM, Coscia LA, Constantinescu S, Lavelanet AF, Moritz MJ, Armenti VT., Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus. Transplantation 2006; 82: 1698-1702.
13. Merlob P, Stahl B, Klinger G., Tetrada of the possible mycophenolate mofetil embryopathy: A review. Reprod Toxicol 2009; 28: 105-108.
14. Anderka MT, Lin AE, Abuelo DN, Mitchell AA, Rasmussen SA., Reviewing the evidence for mycophenolate mofetil as a new teratogen: Case report and review of the literature. Am J Med Genet A 2009; 149A: 1241-1248.
15. Dei Malatesta MF, Rocca B, Gentile T, et al. A case of coloboma in a newborn to a woman taking mycophenolate mofetil in pregnancy after kidney transplantation. Transplant Proc 2009; 41: 1407-1409.
16. Armenti VT, Radomski JS, Moritz MJ, Gaughan WJ, McGrory CH, Coscia LA., Report from the National Transplantation Pregnancy Registry (NTPR): Outcomes of pregnancy after transplantation. Clin Transpl 2003; 131-141.
17. Food and Drug Administration. Single Shared System for Mycophenolate. 2012. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM321261.pdf. Accessed October 11, 2012.
18. CellCept [package insert]. San Francisco, CA: Genentech USA, Inc 2012.
19. Myfortic [package insert]. East Hanover, NJ: Novartis Pharmaceuticals 2012.
20. Food and Drug Administration. Safety Information. Cellcept (mycophenolate mofetil) October 2007. 2007. Available at: http://www.fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152095.htm. Accessed January 25, 2013.
21. El Sebaaly Z, Charpentier B, Snanoudj R., Fetal malformations associated with mycophenolate mofetil for lupus nephritis. Nephrol Dial Transplant 2007; 22: 2722.
22. Parisi MA, Zayed H, Slavotinek AM, Rutledge JC., Congenital diaphragmatic hernia and microtia in a newborn with mycophenolate mofetil (MMF) exposure: Phenocopy for Fryns syndrome or broad spectrum of teratogenic effects ? Am J Med Genet A 2009; 149A: 1237-1240.
23. Ang GS, Simpson SA, Reddy AR., Mycophenolate mofetil embryopathy may be dose and timing dependent. Am J Med Genet A 2008; 146A: 1963-1966.
24. Le Ray C, Coulomb A, Elefant E, Frydman R, Audibert F., Mycophenolate mofetil in pregnancy after renal transplantation: A case of major fetal malformations. Obstet Gynecol 2004; 103: 1091-1094.
25. Department of Health and Human Services. 2011. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/appletter/2011/021560s004ltr.pdf. Accessed July 6, 2012.
26. European best practice guidelines for renal transplantation. Section IV: Long-term management of the transplant recipient. IV.10. Pregnancy in renal transplant recipients. Nephrol Dial Transplant 2002; 17: 50-55.
27. Ostensen M, Lockshin M, Doria A, et al. Update on safety during pregnancy of biological agents and some immunosuppressive anti-rheumatic drugs. Rheumatology (Oxford) 2008; 47: iii28-iii31.
28. Fahy BG, Gouzd VA, Atallah JN., Pregnancy tests with end-stage renal disease. J Clin Anesth 2008; 20: 609-613.
29. Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic. 2008. Available at: http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm148735.htm. Accessed January 29, 2013.
30. OPTN: Organ Procurement and Transplantation Network. 2013. Available at: http://optn.transplant.hrsa.gov/latestData/rptData.asp. Accessed January 25, 2013.
31. Food and Drug Administration. Food and Drug Administration Amendment Act of 2007. 2007. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=110-cong-public-laws&docid=f:publ085.110. Accessed July 15, 2012.
32. Gabardi S, Halloran PF, Friedewald J., Managing risk in developing transplant immunosuppressive agents: The new regulatory environment. Am J Transplant 2011; 11: 1803-1809.
33. Mycophenolate REMS. 2013. Available at: http://www.mycophenolaterems.com. Accessed January 11, 2013.
34. Food and Drug Administration. Cellcept Medication Guide. 2012. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170919.pdf. Accessed October 11, 2012.
35. Food and Drug Administration. Myfortic Medication Guide. 2012. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM172735.pdf. Accessed October 11, 2012.
36. Gabardi S., Understanding risk evaluation and mitigation strategies in organ transplantation. Pharmacotherapy 2011; 31: 714-722.