February 6, 2016
Recommended Topic Related To:


"The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.

Breast cancer in women is the second most common type of cancer in the United States. It forms i"...




  • 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 WARNINGS AND PRECAUTIONS]
  • Advise pregnant women and females of reproductive potential that PERJETA exposure can result in fetal harm, including embryo-fetal death or birth defects [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]
  • Advise females of reproductive potential to use effective contraception while receiving PERJETA and for 7 months following the last dose of PERJETA in combination with trastuzumab [see WARNINGS AND PRECAUTIONS and Use in Special Populations]
  • Advise nursing mothers treated with PERJETA to discontinue nursing or discontinue PERJETA, taking into account the importance of the drug to the mother [see Use in Specific Populations].
  • If PERJETA is administered during pregnancy or if a patient becomes pregnant while receiving PERJETA or within 7 months following the last dose of PERJETA in combination with trastuzumab, immediately report exposure to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who are exposed to PERJETA during pregnancy or within 7 months for PERJETA in combination with trastuzumab prior to conception, 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: 6/12/2015
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.

Breast Cancer

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