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

Date: 14 December 2015

 

Description:

New contraindications have been added to the prescribing information for Cellcept® (mycophenolate mofetil) related to the teratogenic risk. Cellcept® is contraindicated during pregnancy, in women of childbearing potential not using highly effective contraceptive methods, and in women who are breastfeeding. These recommendations were made following a cumulative review of birth defects which showed that mycophenolate is a powerful human teratogen with increased rate of spontaneous abortions or malformations compared to other immunosuppressants. A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of these new contraindications and provide further advice on pregnancy testing as well as contraceptive use for women and men. Please refer to the DHPC issued by Roche (Malaysia) Sdn. Bhd. for further information.

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