August 31, 2015
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Kadcyla

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Kadcyla

PATIENT INFORMATION

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 Use In Specific Populations].

Advise females of reproductive potential to use effective contraception while receiving KADCYLA and for 7 months following the last dose of KADCYLA [see 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].

Advise women who are exposed to KADCYLA during pregnancy or become pregnant while receiving KADCYLA or within 7 months following the last dose of KADCYLA, to immediately report exposure to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who are exposed to KADCYLA during pregnancy or within 7 months prior to conception, to enroll in the MotHER Pregnancy Registry by contacting 1-800-690- 6720 [see Use in Specific Populations].

Last reviewed on RxList: 6/16/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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