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.
What it Treats
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 and Serious Side Effects
What should I know about side effects with PERJETA?
- Not all people have serious side effects; however, side effects with PERJETA therapy 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
What are the most serious side effects?
PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those 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
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 6 months after a patient’s last dose of PERJETA. If a patient is a mother who is breastfeeding, the patient should talk with her doctor about either stopping breastfeeding or stopping PERJETA
- If a patient thinks she may be pregnant, the patient should contact their healthcare provider immediately
If a patient is exposed to PERJETA during pregnancy, the patient is encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720.
What are other possible serious side effects?
- PERJETA should not be used in patients who are allergic to pertuzumab or to any of the ingredients in 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
How will the doctor and patient know if PERJETA is right for the patient?
PERJETA has only been shown to work 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.
What are the most common side effects?
The most common side effects of PERJETA when given with Herceptin and docetaxel (chemotherapy) for treatment of breast cancer that has spread to other parts of the body (metastatic) are:
- Hair loss
- Low levels of white blood cells with or without a fever
- Feeling tired
- Damage to the nerves (numbness, tingling, pain in hands/feet)
Report side effects to Genentech and the FDA. Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please see PERJETA full Prescribing Information including Most Serious Side Effect for additional Important Safety Information at <a href="<a href="http://www.perjeta.com">http://www.perjeta.com">www.perjeta.com</a>.