The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA
The U.S. Food and Drug Administration approved Herzuma (trastuzumab-pkrb, Celltrion Inc.) as a biosimilar to Herceptin (trastuzumab, Genentech Inc.) for patients with HER2-overexpressing breast cancer.
Herzuma is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer.
Common expected side effects of Herzuma for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected side effects of Herzuma include worsening of chemotherapy-induced neutropenia.
Herceptin, the labeling for Herzuma contains a Boxed Warning to alert health care professionals and patients about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at email@example.com.
additional drug information, please visit the DDI Web page.
up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info.