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

Metastatic Breast Cancer

  • PERJETA® (pertuzumab) is indicated for use in combination with Herceptin® (trastuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

Early Breast Cancer
PERJETA® (pertuzumab) is indicated for use in combination with Herceptin® (trastuzumab) and chemotherapy for

  • the 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 (EBC)
  • the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) at high risk of recurrence

Important Safety Information

BOXED WARNINGS: Left Ventricular Dysfunction and Embryo-Fetal Toxicity

  • PERJETA can result in subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (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

Most Common Adverse Reactions

In the treatment of metastatic breast cancer, 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

In the neoadjuvant treatment of breast cancer

  • The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 4 cycles were alopecia, neutropenia, diarrhea, and nausea
  • The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 3 cycles following 3 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) were diarrhea, nausea, alopecia, neutropenia, vomiting, and fatigue
  • The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) administered for 6 cycles were diarrhea, alopecia, neutropenia, nausea, fatigue, vomiting, anemia, and thrombocytopenia
  • The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and paclitaxel administered for 4 cycles following 4 cycles of dose-dense doxorubicin and cyclophosphamide (ddAC) were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache
  • The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia

In the adjuvant treatment of breast cancer, the most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting

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 full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.