Direct healthcare professional communication on the strengthened advice for pregnancy prevention when using mycophenolic acid/mycophenolate mofetil/mycophenolate sodium: CellCept, Mikofenolat Stada, Mikofenolat Genera, Myfortic, Trixin
02.12.2015
Roche d.o.o., Stada d.o.o., Genera d.d., Novartis Hrvatska d.o.o. and Pliva Hrvatska d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), have informed healthcare professionals about the strengthened advice for pregnancy prevention when using mycophenolic acid, which is also available in authorised medicinal products as pro-drug mycophenolate mofetil, as well as in the form of mycophenolate sodium.
Summary
Mycophenolic acid is a powerful human teratogen, which increases the risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy. Therefore the following new contraindications have been added:
- Mycophenolic acid should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
- Mycophenolic acid should not be given to women of childbearing potential who are not using highly effective contraception.
- Mycophenolic acid treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy.
Additionally:
- Physicians should ensure that women and men taking mycophenolic acid understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult a physician if there is a possibility of pregnancy.
- Educational materials will be provided.
Further information
With this direct healthcare professional communication (DHPC), the healthcare professionals are being informed of further advice on pregnancy testing, contraception advice for women and men as well as additional precautions and further background information regarding this safety concern.
Here you may view the direct healthcare professional communication.
The healthcare professionals are being reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends the patients to contact their doctor or pharmacist regarding any adverse reaction they may notice.
