Perjeta (Pertuzumab)

Generic Name

Pertuzumab

Brand Names

Perjeta, Phesgo

FDA approval date: June 08, 2012

Classification: Endoglycosidase

Form: Injection

What is Perjeta (Pertuzumab)?

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: Use in combination with chemotherapy as: neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer.

Approved To Treat

Breast Cancer

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Brand Information

PERJETA (Pertuzumab)

WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY

Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception

1DOSAGE FORMS AND STRENGTHS

Injection: 420 mg/14 mL (30 mg/mL) clear to slightly opalescent and colorless to pale brown solution in a single-dose vial

2CONTRAINDICATIONS

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

3ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label:

Left Ventricular Dysfunction
Embryo-Fetal Toxicity
Infusion-Related Reactions
Hypersensitivity Reactions/Anaphylaxis

3.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

4DESCRIPTION

Pertuzumab is a recombinant humanized monoclonal antibody and HER2/neu receptor antagonist that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa.

PERJETA (pertuzumab) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution for intravenous infusion. Each single-dose vial contains 420 mg of pertuzumab,glacial acetic acid (9.2 mg), histidine (43.5 mg), polysorbate 20 (2.8 mg), and sucrose (575.1 mg) with a pH of 6.

5PRINCIPAL DISPLAY PANEL - 14 mL Vial Carton

NDC 50242-145-01

Perjeta

420 mg/ 14 mL

Dilute Prior To Use

Rx only

1 vial

11029352

PRINCIPAL DISPLAY PANEL - 14 mL Vial Carton