Drugs Xagena
Celgene, in agreement with the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMEA ) has informed Healthcare Professionals about the following new safety information relating to Revlimid ( Lenalidomide ):
Preliminary results of an ongoing study show that Lenalidomide is teratogenic in animals and is expected to be teratogenic in humans
The SmPC for Revlimid has been updated, to reflect these preclinical results and clearly state that a teratogenic effect of Lenalidomide in humans is expected
Healthcare Professionals are advised to carefully follow the pregnancy prevention measures as specified in the Pregnancy Prevention Programme and the SmPC to avoid any foetal exposure to Lenalidomide during pregnancy
Revlimid is authorised in combination with Dexamethasone for the treatment of multiple myeloma patients who have received at least one previous therapy.
Important preliminary results have been obtained from an ongoing primate embryofoetal development study conducted with Lenalidomide ( final results expected March 2009 ). Malformations ( short limbs, bent digits, wrist and/or tail, supernumerary or absent digits ) were observed in the offspring of female monkeys who received Lenalidomide during pregnancy.
Thalidomide produced similar types of malformations in the same study.
Although preliminary, these results show that Lenalidomide is teratogenic in animals, in a similar way as Thalidomide, and is expected to be teratogenic in humans.
Prior to these findings, the EU Summary of Product Characteristics ( SmPC ) stated that Revlimid was a potential human teratogen and the Revlimid Pregnancy Prevention Programme was put in place to provide guidance to healthcare professionals and patients to avoid foetal exposure.
In light of these findings, the SmPC for Revlimid has been updated, to reflect these preclinical results and clearly state that a teratogenic effect of Lenalidomide in humans is expected.
Women of childbearing potential as defined in the SmPC should use one effective method of contraception for at least 4 weeks before therapy, during therapy, during dose interruptions and 4 weeks after therapy has finished. A pregnancy test must be performed before initiating treatment, monthly thereafter and 4 weeks after the end of treatment.
Source: Medicines and Healthcare product Regulatory Agency MHRA, 2008
XagenaMedicine_2008
