Generic Name

Pertuzumab

Brand Names
Perjeta, Phesgo
FDA approval date: June 08, 2012
Classification: Endoglycosidase
Form: Injection

What is Perjeta (Pertuzumab)?

PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

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Related Clinical Trials

A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

Summary: This phase III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin Hylecta \[TM\]) or pertuzumab, trastuzumab and hyaluronidase-zzxf (Phesgo \[TM\]) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial cancer. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to spe...

A Phase 1/2 Study of DS-8201a (NSC# 807708) in Children, Adolescents, or Young Adults With Recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor

Summary: This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug...

Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib

Summary: The goal of this study is to test a novel nurse-delivered patient navigation program for women with HER2+ metastatic breast cancer (mBC) receiving tucatinib, trastuzumab, and capecitabine. The program will focus on enhancing understanding of the treatment regimen, managing symptoms and adherence, and improving coping and self-management skills. If successful, the program could be integrated into c...

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