PERJETA Indication and Important Safety Information
PERJETA® (pertuzumab) is a HER2/neu receptor antagonist indicated in combination with Herceptin® (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 WARNINGS: Cardiomyopathy and Embryo-Fetal Toxicity
- PERJETA administration can result in subclinical and clinical cardiac failure. Evaluate left ventricular function in all patients prior to and during treatment with PERJETA. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
- Exposure to PERJETA can result in embryo-fetal death and 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
- PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
- PERJETA has been associated with infusion and hypersensitivity reactions/anaphylaxis
- Detection of HER2 protein overexpression is necessary for selection of patients appropriate for PERJETA therapy
- In metastatic breast cancer, the most common adverse reactions (>30%) seen with PERJETA in combination with Herceptin 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.
PERJETA® and the Access Solutions logo are registered trademarks of Genentech, Inc.