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Genentech’s Perjeta Significantly Extends Survival In People With HER2-Positive Metastatic Breast Cancer

Genentech and Roche have spent more than 30 years studying the role of HER2 in cancer, and Perjeta is a result of this research. A companion diagnostic test is used to determine if a person is HER2-positive and whether treatment with Perjeta and Herceptin is appropriate.

Perjeta Indication Statement

Perjeta ® (pertuzumab) is approved for use in combination with Herceptin ® (trastuzumab) and docetaxel chemotherapy in people with HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic disease.

Important Safety Information

  • Because side effects from this treatment are common, it is important to know what side effects may happen and what symptoms patients should watch for
  • A patient’s doctor may stop treatment if serious side effects happen. Patients must contact their healthcare team right away if they have questions or are worried about any side effects

Most Serious Side Effect of Perjeta Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.

  • Birth control should be used while receiving Perjeta and for six months after a patient’s last dose of Perjeta. Patients who are breastfeeding should talk with their doctor about either stopping breastfeeding or stopping Perjeta
  • If a patient thinks she may be pregnant, she should contact her healthcare provider immediately
  • If a patient is exposed to Perjeta during pregnancy, she is encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720

Other Possible Serious Side Effects

  • Heart problems: Perjeta can result in heart problems, including for those patients without symptoms (such as reduced heart function) and those patients with symptoms (such as congestive heart failure). A patient’s doctor may run tests to monitor the patient’s heart function before and during treatment with Perjeta
  • Infusion-related reactions: Perjeta is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving Perjeta, Herceptin, and docetaxel chemotherapy were feeling tired, abnormal or altered taste, allergic reactions, muscle pain and vomiting
  • Severe allergic reactions: Some people receiving Perjeta may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly and may affect many areas of the body
  • Perjeta has been shown to work only in people with HER2-positive breast cancer. Patients must have a HER2 test to know if their breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as Perjeta

Most Common Side Effects

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy are:

  • Diarrhea
  • Hair loss
  • Low levels of white blood cells with or without a fever
  • Nausea
  • Feeling tired
  • Rash
  • Damage to the nerves (numbness, tingling, pain in hands/feet)

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

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