Interstitial Lung Disease and Embryo-Fetal Toxocity
- Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms [see DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.1)].
- Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception [see WARNINGS AND PRECAUTIONS (5.4), Use in Specific Populations (8.1, 8.3)].
Patient Counseling Information
Updated January 2020