CellCept® (mycophenolate mofetil): Update to post-treatment contraception period for women of childbearing potential (extension from 6 weeks to 6 months)

A Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals that the recommended duration of post-treatment contraception with Cellcept® for women of childbearing potential has been extended from 6 weeks to 6 months. This update follows a review of current regulatory guidance and scientific best practices, with the 6-month duration determined in accordance with updated EMA’s recommendations for medicinal products with genotoxic potential. The recommendation takes into account both drug elimination and the maturation cycle of human oocytes to minimise the potential risk of embryo-fetal exposure. Healthcare professionals are advised to ensure that women of childbearing potential are counselled on the increased risk of pregnancy loss and congenital malformations before starting treatment, and that they use two reliable forms of contraception simultaneously before, during, and for 6 months after discontinuation of treatment. This information will be updated in the product information and in associated risk minimisation materials. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system. 

Step 1: Select your profession under ‘For Healthcare Professionals’. 

Step 2: Click on ‘Useful links’. 

Step 3: Click on ‘MOH Alert’ and log in via Singpass. 

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.