Enhertu Use In Pregnancy & Lactation

Contraception in Males and Females: Women of childbearing potential should use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose.
Men with female partners of childbearing potential should use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose.
Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. There are no available data on the use of ENHERTU in pregnant women. However, in postmarketing reports, use of trastuzumab, a HER2 receptor antagonist, during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Based on findings in animals and its mechanism of action, the topoisomerase I inhibitor component of ENHERTU can also cause embryo-fetal harm when administered to a pregnant woman (see Pharmacology: Toxicology: Nonclinical safety data under Actions).
Administration of ENHERTU to pregnant women is not recommended, and patients should be informed of the potential risks to the fetus before they become pregnant. Women who become pregnant must immediately contact their doctor. If a woman becomes pregnant during treatment with ENHERTU or within 7 months following the last dose of ENHERTU, close monitoring is recommended.
Breastfeeding: It is not known if ENHERTU is excreted in human milk. Since many medicinal products are excreted in human milk and because of the potential for serious adverse reactions in breastfeeding infants, women should discontinue breastfeeding prior to initiating treatment with ENHERTU. Women may begin breastfeeding 7 months after concluding treatment.
Women of Childbearing Potential: Pregnancy status of women of childbearing potential should be verified prior to initiation of ENHERTU.
Fertility: No dedicated fertility studies have been conducted with ENHERTU. Based on results from animal toxicity studies, ENHERTU may impair male reproductive function and fertility.
It is not known whether trastuzumab deruxtecan or its metabolites are found in seminal fluid. Before starting treatment, male patients should be advised to seek counseling on sperm storage. Male patients must not freeze or donate sperm throughout the treatment period, and for at least 4 months after the final dose of ENHERTU.