Perjeta

Perjeta (pertuzumab) is a HER2/neu receptor antagonist used to treat HER2-positive breast cancer. It works by blocking HER2 receptors on cancer cells, inhibiting signals that drive tumor growth. It is given via an intravenous infusion by a healthcare provider.

Perjeta is used to treat HER2-positive breast cancer in the following settings:

• Metastatic breast cancer (MBC): In combination with trastuzumab and docetaxel, for adults who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
• Neoadjuvant treatment (given before surgery): In combination with trastuzumab and chemotherapy, for adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (greater than 2 cm in diameter or node positive), as part of a complete early breast cancer treatment regimen.
• Adjuvant treatment (given after surgery): In combination with trastuzumab and chemotherapy, for adults with HER2-positive early breast cancer at high risk of recurrence.

Perjeta may also be used for purposes not listed in this medication guide.

Perjeta (pertuzumab) received FDA approval on June 8, 2012, and is manufactured by Genentech. There is an interchangeable biosimilar to Perjeta called Phoerdy (pertuzumab-dpzb).

Perjeta has a Boxed Warning for left ventricular dysfunction and embryo-fetal toxicity (toxicity to an unborn child).

• Left ventricular dysfunction: Perjeta can cause subclinical and clinical cardiac failure, including decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Your heart function will be checked before you start treatment and at regular intervals during treatment. Your cancer treatments may need to be paused or permanently stopped if your heart function declines significantly.

Call your doctor at once if you have new or worsening shortness of breath, cough, swelling in your ankles or legs, palpitations, or unexplained weight gain of more than 5 pounds in 24 hours, dizziness, or loss of consciousness.

• Embryo-fetal toxicity: Using Perjeta with trastuzumab during pregnancy or within 7 months before becoming pregnant can harm your unborn baby. Tell your doctor right away if you know or think you may be pregnant.

If you are exposed to Perjeta in combination with trastuzumab during pregnancy, or within 7 months before conception, report your pregnancy to Genentech at 1-888-835-2555.

Use effective contraception during treatment and for 7 months after your last dose of Perjeta in combination with trastuzumab.

Do not use Perjeta if you are allergic to pertuzumab or to any of its excipients.

Tell your doctor if you have ever had:

• heart disease, congestive heart failure, or a serious heart rhythm disorder requiring treatment
• a heart attack
• uncontrolled high blood pressure
• a decrease in LVEF to below 50% during prior trastuzumab therapy
• radiation treatment to the chest area
• prior anthracycline chemotherapy (cumulative doxorubicin exposure greater than 360 mg/m²)

Also tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding

Perjeta has not been studied in patients with a pretreatment LVEF below 50% or in those with conditions that could impair left ventricular function.

Pregnancy

Do not use Perjeta during pregnancy or within 7 months of conception because it can cause fetal harm, including embryo-fetal death and birth defects. Your pregnancy status will be verified before starting treatment. Use effective contraception during treatment with pertuzumab and trastuzumab, and for at least 7 months after your last dose.

If you are exposed to Perjeta in combination with trastuzumab during pregnancy or within 7 months before conception, contact Genentech at 1-888-835-2555. Your name may be listed on a pregnancy registry to track the effects on the baby.

Breastfeeding

It may not be safe to breastfeed while using Perjeta with trastuzumab, or for up to 7 months after your last dose. Talk to your doctor about the risks and benefits before breastfeeding.

Common side effects

Common side effects of Perjeta vary by treatment setting:

• Metastatic breast cancer (with trastuzumab and docetaxel): The most common side effects (occurring in more than 30% of patients) were diarrhea, hair loss, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.
• Neoadjuvant treatment (pre-surgery, with trastuzumab and docetaxel): The most common side effects (more than 30% of patients) were hair loss, neutropenia, diarrhea, and nausea. Side effects may vary depending on the specific chemotherapy regimen used.
• Adjuvant treatment (post-surgery, with trastuzumab and chemotherapy): The most common side effects (more than 30% of patients) were diarrhea, nausea, hair loss, fatigue, peripheral neuropathy, and vomiting.

Serious side effects

Perjeta can also cause the following serious side effects:

• Infusion-related reactions: Perjeta can cause serious and potentially fatal infusion-related reactions. You will be monitored closely during and after each infusion. Tell your caregiver right away if you develop fever, chills, fatigue, headache, nausea, vomiting, or a fast heartbeat during your infusion.
• Hypersensitivity reactions: Perjeta can cause severe allergic reactions, including anaphylaxis and angioedema. Get emergency medical help if you have signs of a severe allergic reaction to Perjeta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening shortness of breath or cough
• palpitations or fluttering in your chest
• swelling in your lower legs
• dizziness or loss of consciousness
• low blood cell counts - fever, chills, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed
• signs of tumor cell breakdown - confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands, feet, or around your mouth

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Perjeta is given as an intravenous (IV) infusion by a healthcare provider. It is not given as an IV push or bolus injection.

The initial (loading) dose is 840 mg, given as a 60-minute infusion. After that, the maintenance dose is 420 mg, given every 3 weeks as a 30- to 60-minute infusion. The specific chemotherapy used alongside Perjeta and trastuzumab, and the total duration of treatment, will depend on whether you are being treated for metastatic, neoadjuvant, or adjuvant breast cancer.

• Metastatic breast cancer: Perjeta is given with trastuzumab and docetaxel every 3 weeks.
• Neoadjuvant treatment: Perjeta is given every 3 weeks for 3 to 6 cycles before surgery as part of a chemotherapy regimen. After surgery, Perjeta and trastuzumab are continued to complete 1 year of treatment (up to 18 cycles).
• Adjuvant treatment: Perjeta is given every 3 weeks for a total of 1 year (up to 18 cycles), starting on day 1 of the first taxane-containing chemotherapy cycle.

You will be observed for 30 to 60 minutes after each Perjeta infusion before any subsequent infusions are administered. Your heart function will be monitored before starting and periodically during treatment.

Dose reductions are not recommended for Perjeta. If you miss a scheduled infusion, contact your doctor for instructions.

Call your doctor for instructions if you miss an appointment for your Perjeta infusion. If less than 6 weeks have passed since your last dose, your doctor will give you the standard 420 mg maintenance dose as soon as possible rather than waiting until the next scheduled dose. If 6 weeks or more have passed, you will need to restart with the 840 mg loading dose.

Avoid becoming pregnant during treatment and for at least 7 months after your last dose of Perjeta in combination with trastuzumab. Use effective contraception during this period.

Other drugs may interact with pertuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Perjeta is manufactured by Genentech, Inc., a member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. U.S. License No. 1048.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Perjeta.

Perjeta (pertuzumab) - Genentech, Inc.

Perjeta interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Poherdy (pertuzumab-dpzb) - Shanghai Henlius Biotech, Inc.

Poherdy