Perjeta® (pertuzumab)

Side Effect Reporting

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.

Indication

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.