Information for Patients / Medical Professionals

Perjeta® (pertuzumab)

• Full Prescribing Information including Most Serious Side Effect
• Material Safety Data Sheet

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 and BOXED WARNINGS

Boxed WARNING: Embryo-Fetal Toxicity

• 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

Left Ventricular Dysfunction

• 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 8.3% of patients in the placebo-treated group
• Assess LVEF prior to initiation of Perjeta and at regular intervals (e.g., every 3 months) 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 the LVEF has not improved or has declined further

Infusion-Associated Reactions, Hypersensitivity Reactions/Anaphylaxis

• Perjeta has been associated with infusion and hypersensitivity reactions
• 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
• In the randomized trial, the overall frequency of hypersensitivity reactions/anaphylaxis was 10.8% in the Perjeta-treated group and 9.1% in the placebo-treated group
• 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

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

•  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 (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Please see the Perjeta full Prescribing Information including Boxed WARNING for additional Important Safety Information at www.perjeta.com.