Daraxonrasib Pregnancy, Lactation and Contraception Safety

　　Daraxonrasib is a RAS GTPase-family inhibitor used in selected RAS-driven tumors,including previously treated metastatic pancreatic ductal adenocarcinoma in adults.Its reproductive-safety rule is simple:animal data demonstrate fetal harm,human pregnancy data are lacking,so pregnancy testing and contraception must precede and accompany therapy.

　　Pregnancy risk：In an animal reproduction study,pregnant mice received oral daraxonrasib 25,50 and 75mg/kg/day during organogenesis.At≥50mg/kg/day—about 2.5 times or more the recommended human exposure by AUC—findings included post-implantation loss,reduced numbers of live fetuses,decreased fetal body weight,and structural malformations involving eyes,limbs,palate,gonads,great vessels,kidneys and bones.No controlled human pregnancy data are available.Pregnant patients should be counseled about potential teratogenic and embryolethal risk;if pregnancy occurs during treatment,contact the prescriber promptly for benefit-risk review rather than continuing unsupervised.

　　Pre-treatment pregnancy check：In people with reproductive potential,confirm pregnancy status before initiation.A delayed period,positive test,or any possibility of conception should trigger obstetric/genetic and oncology discussion before the first dose.

　　Contraception：People with reproductive potential should use effective contraception during daraxonrasib therapy and for 1 week after the last dose.Males with partners of reproductive potential should likewise use effective contraception during therapy and for 1 week after the last dose;the method is chosen according to the partner’s fertility status,concomitant drugs and overall treatment plan.

　　Lactation：There are no data on daraxonrasib or its metabolites in human milk,on effects in the breastfed infant,or on milk production.Because serious adverse reactions are possible in adults,people who are breastfeeding should not nurse during treatment and for 1 week after the final dose;discuss formula feeding,milk-expression planning,and restart timing with a lactation or pediatric specialist.

　　Other groups：Pediatric safety and efficacy are not established.Pregnancy,preconception and lactation decisions should be documented in informed consent and managed jointly by oncology,reproductive medicine,obstetrics and,when relevant,pediatrics.