PERJETA (pertuzumab)

Important Safety Information

Boxed WARNINGS: Cardiomyopathy and Embryo-Fetal Toxicity

  • PERJETA administration can result in subclinical and clinical cardiac failure. Evaluate left ventricular function in all patients prior to and during treatment with PERJETA. 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. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. 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
  • Detection of HER2 protein overexpression is necessary for selection of patients appropriate for PERJETA therapy
  • In metastatic breast cancer, the most common adverse reactions (>30%) seen with PERJETA in combination with Herceptin and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy

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 PERJETA full Prescribing Information including Boxed WARNINGS for additional Important Safety Information.

Professional Resources & Downloads

Professional Resources and Downloads

Within this section, healthcare providers can find important supplemental information to help in the treatment of patients with HER2+ (HER2-positive) MBC.

Genentech resources

Below, click to access resources and downloads designed to inform and support healthcare professionals.

CLINICAL RESOURCES

PERJETA Prescribing Information ›

Full Prescribing Information for PERJETA

CLEOPATRA Clinical Data Brochure ›

Highlights from the published CLEOPATRA trial

PERJETA Core Data Brochure ›

Comprehensive overview of the most important information about PERJETA, including PERJETA MOA, CLEOPATRA study design, efficacy, safety, dosing and administration, and Access Solutions

Dosing and Administration Brochure ›

Dosing and administration guidelines to ensure patients receive accurate dosing

PERJETA Nurse Resource ›

Nurse-focused brochure that highlights PERJETA information, including trial design, efficacy, MOA, dosing and administration, and safety

PERJETA Patient Brochure ›

Helps you educate patients about HER2-positive breast cancer and PERJETA therapy (mechanism of action, benefits, risks, and administration)
También disponible en español ›

NON-CLINICAL RESOURCES

Billing and Coding Information ›

Key billing and coding information, including permanent J-code and claim submission tips

Permanent J-Code J9306
Available for Use!

PERJETA Material Safety Data Sheet ›

Material Safety Data Sheet

FINANCIAL RESOURCES

Co-pay Card Information ›

PERJETA plus Herceptin co-pay card benefits

PERJETA Patient Call-in Center ›

Resource for additional questions or concerns and 24/7 support

PERJETA Access Solutions ›

Information on financial assistance to help support your patients

The Access Solutions logo is a registered trademark of Genentech, Inc.

Nurses — click here to access the Patient Resources page for additional information for patients and caregivers.

Indication

PERJETA® (pertuzumab) is a HER2/neu receptor antagonist indicated in combination with Herceptin® (trastuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Important Safety Information

Boxed WARNINGS: Cardiomyopathy and Embryo-Fetal Toxicity

  • PERJETA administration can result in subclinical and clinical cardiac failure. Evaluate left ventricular function in all patients prior to and during treatment with PERJETA. 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. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Advise patients of these risks and the need for effective contraception
    • Verify pregnancy status prior to the initiation of PERJETA. Advise patients of the risks of embryo-fetal death and birth defects and the need for contraception during and after treatment. Advise patients to contact their healthcare provider immediately if they suspect they may be pregnant
    • Encourage women who may be exposed to PERJETA during pregnancy to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720
    • Monitor patients who become pregnant during PERJETA therapy for oligohydramnios

Additional Important Safety Information

PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients.

Left Ventricular Dysfunction (LVD)
  • In Study 1, for patients with MBC, left ventricular dysfunction, which includes symptomatic left ventricular systolic dysfunction (LVSD) (congestive heart failure) and decreases in left ventricular ejection fraction (LVEF), occurred in 4.4% of patients in the PERJETA-treated group and in 8.3% of patients in the placebo-treated group
  • Assess LVEF prior to initiation of PERJETA and at regular intervals (eg, every 3 months in the metastatic setting) during treatment to ensure that LVEF is within your institution’s normal limits
  • Withhold PERJETA and Herceptin and repeat LVEF assessment within 3 weeks in patients with significant decrease in LVEF. Discontinue PERJETA and Herceptin if LVEF has not improved or has declined further
Infusion-Associated Reactions
  • PERJETA has been associated with infusion reactions
  • In Study 1, for patients with MBC, when all drugs were administered on the same day, the most common infusion reactions in the PERJETA-treated group (≥1.0%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting
  • If a significant infusion reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent discontinuation in patients with severe infusion reactions
Hypersensitivity Reactions/Anaphylaxis
  • In Study 1, the overall frequency of hypersensitivity/anaphylaxis reactions was 10.8% in the PERJETA-treated group and 9.1% in the placebo-treated group. The incidence of Grades 3-4 reactions was 2.0% and 2.5%, respectively, according to NCI-CTCAE (version 3)
  • Patients should be observed closely for hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis, has been observed in clinical trials of PERJETA
HER2 Testing
  • Detection of HER2 protein overexpression is necessary for selection of patients appropriate for PERJETA therapy because these are the only patients studied and for whom benefit has been shown
Most Common Adverse Reactions
  • In metastatic breast cancer, the most common adverse reactions (>30%) with PERJETA in combination with Herceptin and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy

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 PERJETA full Prescribing Information including Boxed WARNINGS for additional Important Safety Information.