"The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
HER2 is a protein involved in normal cell growth. It is foun"...
- Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see BOXED WARNING, Cardiomyopathy].
- Advise pregnant women and women of childbearing potential that Herceptin exposure can result in fetal harm [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
- Advise women of childbearing potential to use effective contraceptive methods during treatment and for a minimum of six months following Herceptin [see WARNINGS AND PRECAUTIONS].
- Advise nursing mothers treated with Herceptin to discontinue nursing or discontinue Herceptin, taking into account the importance of the drug to the mother [see Use In Specific Populations].
- Encourage women who are exposed to Herceptin during pregnancy to enroll in MotHER- the Herceptin Pregnancy Registry (1-800-690-6720) [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
Last reviewed on RxList: 3/19/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Herceptin Information
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