PERJETA Indication and Important Safety Information
PERJETA® (pertuzumab) is a HER2/neu receptor antagonist indicated for:
- Treatment of metastatic breast cancer 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
- Use in combination with trastuzumab and docetaxel as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival
Limitations of Use:
- The safety of PERJETA as part of a doxorubicin-containing regimen has not been established
- The safety of PERJETA administered for greater than 6 cycles for early breast cancer has not been established
Important Safety Information
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 the treatment of MBC, 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
Most Common Adverse Reactions in Neoadjuvant Treatment of Breast Cancer:
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia
- The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at 1-888-835-2555
Please see PERJETA full Prescribing Information including Boxed WARNINGS for additional Important Safety Information.
PERJETA® and the Access Solutions logo are registered trademarks of Genentech, Inc.