You may also report side effects to Genentech at (888) 835-2555.
Perjeta® (pertuzumab) is a HER2/neu receptor antagonist indicated for:
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 Herceptin® (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 and BOXED WARNINGS
Boxed WARNINGS: Left Ventricular Dysfunction and Embryo-Fetal Toxicity
PERJETA administration can result in subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. 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. 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
Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.
Please see PERJETA full Prescribing Information including Most Serious Side Effect for additional Important Safety Information at www.perjeta.com.
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