"May 14, 2013 -- Actress and activist Angelina Jolie's recent decision to have a preventive double mastectomy highlights the difficult choices facing women who find out they have a high risk for breast cancer because of their genes.
- Inform patients of the possibility of severe liver injury and advise patients to immediately seek medical attention if they experience symptoms of acute hepatitis such as nausea, vomiting, abdominal pain (especially RUQ abdominal pain), jaundice, dark urine, generalized pruritus, anorexia, etc. [see WARNINGS AND PRECAUTIONS].
- 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, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see WARNINGS AND PRECAUTIONS].
- Advise pregnant women and females of reproductive potential that KADCYLA exposure can result in fetal harm, including embryo-fetal death or birth defects [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
- Advise females of reproductive potential to use effective contraception while receiving KADCYLA and for 6 months following the last dose of KADCYLA [See WARNINGS AND PRECAUTIONS and Use in Specific Populations].
- Advise nursing mothers treated with KADCYLA to discontinue nursing or discontinue KADCYLA, taking into account the importance of the drug to the mother [see Use In Specific Populations].
- Encourage women who are exposed to KADCYLA during pregnancy to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
Last reviewed on RxList: 7/29/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Kadcyla Information
Report Problems to the Food and Drug Administration
Find support and advances in treatment.