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Questions to ask your doctor before and during treatment with PERJETA + Herceptin-based therapy

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Perjeta® (pertuzumab) is a prescription medicine used with trastuzumab and chemotherapy designed to treat HER2-positive breast cancer before surgery (neoadjuvant treatment) in adults with HER2-positive for locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen, and after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer with high risk of recurrence. Perjeta is also approved in combination with trastuzumab and docetaxel in adults with HER2-positive metastatic breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease. Perjeta works by targeting the HER2 receptor on cancer cells, preventing the cells from growing and spreading.

Perjeta is given through an IV infusion in a healthcare setting. The initial dose is 840 mg infused over 60 minutes, followed every three weeks by a dose of 420 mg infused over 30-60 minutes.

Serious side effects of Perjeta include heart problems, death of an unborn baby, and birth defects. Perjeta should not be used in patients who are allergic to Perjeta or to any of the ingredients in Perjeta. Other possible serious and sometimes fatal side effects include infusion-related reactions and severe allergic reactions. The most common side effects of Perjeta when given with trastuzumab and chemotherapy include constipation, damage to the nerves, nausea, vomiting, diarrhea, low levels of red and white blood cells, thrombocytopenia, weakness or feeling tired, rash, hair loss, headache, mouth sores or blisters, and muscle pain. Talk to your doctor about any and all side effects you experience.

Important Safety Information

What is PERJETA?

PERJETA® (pertuzumab) is a prescription medicine approved for use in combination with trastuzumab and chemotherapy for:

  • Use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer
  • Use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back

PERJETA® (pertuzumab) is a prescription medicine approved for use in combination with trastuzumab and docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer.

What are the possible side effects of PERJETA?

PERJETA may cause serious side effects, including:

PERJETA can cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure)

  • Your doctor will run tests to monitor your heart function before and during treatment
  • Based on these tests, your treatment may be interrupted or discontinued
  • Contact a health care professional immediately if you experience any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness

Receiving PERJETA during pregnancy can cause the death of an unborn baby and birth defects

  • Your doctor will verify your pregnancy status before treatment begins
  • Birth control should be used while receiving PERJETA and for 7 months after your last dose of PERJETA. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping PERJETA
  • If you think you may be pregnant, you should contact your healthcare provider immediately
  • If you are exposed to PERJETA during pregnancy, or become pregnant while receiving PERJETA or within 7 months following the last dose of PERJETA with trastuzumab, you are encouraged to report PERJETA exposure to Genentech at 1-888-835-2555

Who should not take PERJETA?

PERJETA should not be used in patients who are allergic to pertuzumab or to any of the ingredients in PERJETA.

What are the other possible side effects of PERJETA?

Serious side effects of PERJETA may also include:

  • Infusion-related reactions: PERJETA is given as an infusion. PERJETA can cause serious infusion-related reactions, some fatal. When given alone, the most common infusion-related reactions were fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting. When given with trastuzumab and docetaxel, the most common infusion-related reactions were fatigue, altered taste, hypersensitivity, muscle pain, and vomiting
  • Severe allergic reactions: PERJETA can cause hypersensitivity reactions, including anaphylaxis and fatal events. Contact a health care professional immediately if you experience any of the following symptoms: swelling of the face, lips or tongue, trouble breathing, or chest pains

The most common side effects of PERJETA include:

The most common side effects of PERJETA when given with trastuzumab and chemotherapy prior to surgery for early breast cancer include:

  • Constipation
  • Damage to the nerves (numbness, tingling, pain in hands/feet)
  • Diarrhea
  • Fatigue
  • Hair loss
  • Headache
  • Decreased red blood cell counts, white blood cell counts, and platelet counts
  • Mouth sores or blisters
  • Nausea
  • Muscle pain
  • Vomiting
  • Weakness

The most common side effects of PERJETA when given with trastuzumab and chemotherapy after surgery for early breast cancer include:

  • Diarrhea
  • Nausea
  • Hair loss
  • Fatigue
  • Damage to the nerves (numbness, tingling, pain in hands/feet)
  • Vomiting

The most common side effects of PERJETA when given with trastuzumab and docetaxel for metastatic breast cancer include:

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

Side effects may vary based on chemotherapy regimen. These are not all the possible side effects of PERJETA. Call your healthcare provider for medical advice about side effects. 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 1-877-436-3683.

Before you take PERJETA, tell your healthcare provider about all of your medical conditions, including if you:

  • Have a history of heart disease
  • Are pregnant or plan to become pregnant. PERJETA can harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if PERJETA passes into your breastmilk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for additional Important Safety Information, including most serious side effects.

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