Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
In February 2023, the Ministry of Health, Labor and Welfare of Japan issued guidance outlining the conditions under which contraception is recommended after the last dose and basic principles regarding the duration of contraception. The guidance is intended to minimize the potential for developmental and genotoxic risks in the next generation and beyond due to the administration of drugs to fertile patients. Based on non-clinical, clinical, and post-marketing information, this guidance describes the need for contraception at the time of the last dose and thereafter in male patients of reproductive potential, and the methods and duration of contraception when considering the risk of developmental and genotoxic effects of the drug. The basic idea is that for drugs with genotoxic properties, the period of time after the blood concentration of the drug has decreased sufficiently + 3 months (considered the period of time involved in spermatogenesis). In addition to the effect on the male patient's sperm, the effect on the female partner, who is exposed to the drug via semen, should also be considered. The possibility of migration in semen is also assumed, and this is a point where a barrier method is needed to avoid absorption from the vaginal mucosa. However, there is no clear evidence regarding semen migration. In the case of non-genotoxic, developmental toxicants and chromosome aneuploidy inducers, the effects of semen transfer of the drug must be considered, but it is considered acceptable to establish a contraceptive period or to determine that contraception is unnecessary based on the data on which it is based. This session will consider the concept of contraceptive needs associated with the administration of pharmaceuticals from a clinical standpoint.
