Mycophenolate Mofetil
Risk Factor: CM
Class: Immunologic agents
/ Immunosuppressants
Contents of this page:
Fetal Risk Summary
Mycophenolate mofetil is a purine synthesis inhibitor that is used as an immunosuppressant agent in the prophylaxis of organ rejection in patients receiving allogeneic renal and liver transplants (1). Following oral administration, the drug undergoes rapid and complete hydrolysis to mycophenolic acid, the active moiety.
Reproductive studies have been conducted in rats and rabbits (2). In both species, in the absence of maternal toxicity, fetal resorptions and malformations (type not specified) were observed at doses of 6 mg/kg/day (0.03 times the recommended human dose based on body surface area basis [RHD]) in rats and 90 mg/kg/day (0.92 times the RHD) in rabbits. In rats, a dose of 4.5 mg/kg/day (0.02 times the RHD) produced malformations, principally of the head and eyes (2).
It is not known if mycophenolate mofetil or the active metabolite, mycophenolic acid, crosses the human placenta to the fetus. The molecular weight of the prodrug (about 434), however, is low enough that transfer to the fetus probably occurs. The animal data cited above support this assessment.
No reports describing the use of mycophenolate mofetil during human pregnancy have been located. A 1998 review was also unable to locate reports on the use of the immunosuppressant during pregnancy (1). Because of the potential for congenital defects, use of the drug during pregnancy may represent a high risk to the fetus. Women of childbearing potential who are prescribed this agent should be informed of this risk. The manufacturer recommends these women use effective contraception before and during therapy and for 6 weeks after therapy is stopped (2).
Breast Feeding Summary
Mycophenolate mofetil is excreted into the milk of lactating rats (2). Reports of human use during lactation have not been found. The molecular weight of the drug (about 434) is low enough, however, that passage into human milk should be expected. Mycophenolate mofetil is rapidly and completely hydrolyzed to mycophenolic acid upon absorption. Because of the potential for serious adverse effects in a nursing infant, including an increased frequency of certain infections and the possible development of lymphoma observed in adults (2), mycophenolate mofetil should be considered contraindicated during breast feeding.
References
- Casele HL, Laifer SA. Pregnancy after liver transplantation. Semin Perinatol 1998;22:14955.
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Product information. CellCept. Roche Pharmaceuticals, 1998.
Questions and Answers
What salt content is in Cellcept (mycophenolate mofetil)?, Does Cellcept (mycophenolate mofetil) affect blood presure?
Cellcept tablets, capsules, suspension and intravenous infusion all contain the active ingredient mycophenolate mofetil, which is a type of medicine called an immunosuppressant. These medicines reduce the body's immune response
How serious is Focal Segmental Glomerulo Sclerosis? Anyone has any suggestions to improve treatment for it?, My son aged 6 years is suffering from FSGS. His case history and treatment is given below.
8-Jul-01Treatment for Nephritic Syndrom started with Prednisolone 20mg Daily for my son. DOB : 28.02.2000
28-Nov-02Third relapse. Tab. Endoxan 25 OD introduced and continued upto 22/01/03 together with tapering of Prednisolone from 20mg A/D to 15mg A/D.
29-Oct-03Fifth relapse. Put on Mycophenolate Mofetil (Tab.Mycept) 250mg 1-0-1 + Prednisolone 30mg OD + Repace 25mg OD with slow slow tapering of Prednisolone to 5mg.
29-May-05Seventh relapse observed on tapering Predinsolone 10mg A/D together with Mycept 250mg 1-0-1 with Repace 25mg and half of Rantac 150. Prednislone restored to 20mg OD. Urine Albumine: 4+.
11-May-06No more relapse since 29/05/2005. Medicine is tapered to Prednisolone 5mg OD, Mycept 250mg 0-0-1 and Repace 25mg AD over the period from 29.05.05 to 01.05.06. Presently, the child is helthy. Urine Albumine: Nil.
Having been a child of renal problems and a kidney transplant receiptant in my adult years, I would suggest that you contact the local chapter of the National Kidney Foundation in your area. They may be able to give you information about clinical trials and they may be able to get your son into a trial.
You can find your local office of the National Kidney Foundation by going to http://www.kidney.org/ and clicking on the Find local offices and events link in the upper right hand corner. I wish you and your son the best of luck.
