PERJETA Indication and Important Safety Information
PERJETA® (pertuzumab) is a HER2/neu receptor antagonist indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Boxed WARNING: Embryo-Fetal Toxicity
- Exposure to PERJETA can result in embryo-fetal death or birth defects. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Advise patients of these risks and the need for effective contraception
Additional Important Safety Information
- Left ventricular dysfunction, including cases of congestive heart failure and decreases in left ventricular ejection fraction (LVEF), occurred in patients in the PERJETA-treated group. Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within your institution’s normal limits. Discontinue PERJETA and trastuzumab if the LVEF has not improved or has declined further
- PERJETA has been associated with infusion and hypersensitivity reactions/anaphylaxis. When all drugs were administered on the same day, the most common infusion reactions in the PERJETA-treated group (≥1.0%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting
- Detection of HER2 protein overexpression is necessary for selection of patients appropriate for PERJETA therapy
- The most common adverse reactions (≥30%) seen with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see PERJETA full Prescribing Information including Most Serious Side Effect for additional Important Safety Information.