"The U.S. Food and Drug Administration today allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformi"...
- 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 during pregnancy or within 7 months prior to conception can result in fetal harm. Advise female patients to contact their healthcare provider with a known or suspected pregnancy [see Use In Specific Populations].
- Advise women who are exposed to KADCYLA during pregnancy or who become pregnant within 7 months following the last dose of KADCYLA that there is a pregnancy exposure registry and a pregnancy pharmacovigilance program that monitors pregnancy outcomes. Encourage these patients to enroll in the MotHER Pregnancy Registry and report their pregnancy to Genentech [see Use in Specific Populations].
- Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of KADCYLA [see Use In Specific Populations].
- Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of KADCYLA [see Use In Specific Populations].
- Advise women not to breastfeed during treatment and for 7 months after the last dose of KADCYLA [see Use in Specific Populations].
Last reviewed on RxList: 8/4/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Kadcyla Information
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