CellCept® (mycophenolate mofetil): teratogenic risk – important new pregnancy prevention advice for women and men

Roche would like to inform healthcare professionals of important new pregnancy prevention advice for women and men taking CellCept® (mycophenolate mofetil). This recommendation follows cumulative review of birth defects which provided evidence of an increased rate of congenital malformations and spontaneous abortions associated with mycophenolate in comparison with other medicines. CellCept® is now contraindicated during pregnancy due to its mutagenic and teratogenic potential, in women of childbearing potential not using highly effective contraceptive methods and in women who are breastfeeding. Physicians are advised to ensure that women and men taking CellCept® understood the risk of harm to baby, the need for effective contraception and the need to immediately consult a physician if there is a possibility of pregnancy. Before starting CellCept® therapy, women of childbearing potential must have two negative serum or urine pregnancy tests where the second test should be performed 8 to 10 days after the first one and immediately before starting CellCept®. The Singapore package insert for CellCept® has been strengthened on the above warnings and contraindications.  Published: 14 Mar 2016

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