Pertuzumab
💊 Brand Formulations & Prices
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📖 Official Clinical Monograph
DGDA Approved Prescribing GuidelinesPerjeta is a HER2/neu receptor antagonist indicated for:
Use in combination with Trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Use in combination with Trastuzumab and docetaxel as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival.
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Perjeta is a HER2/neu receptor antagonist indicated for:
Use in combination with Trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Use in combination with Trastuzumab and docetaxel as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival.
Limitations of Use
: The safety of Perjeta as part of a doxorubicin-containing regimen has not been established. The safety of Perjeta administered for greater than 6 cycles for early breast cancer has not been established.
Pertuzumab is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
Left Ventricular Dysfunction
: Perjeta can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF. 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 result in embryo-fetal death and birth defects. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Patients should be advised of these risks and the need for effective contraception.
Metastatic Breast Cancer
: The most common adverse reactions (> 30%) with Perjeta in combination with Trastuzumab and Docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.
Neoadjuvant Treatment of Breast Cancer
:
The most common adverse reactions (>30%) with Perjeta in combination with Trastuzumab and Docetaxel were alopecia, diarrhea, nausea, and neutropenia.
The most common adverse reactions (>30%) with Perjeta in combination with Trastuzumab and Docetaxel when given for 3 cycles following 3 cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.
The most common adverse reactions (>30%) with Perjeta in combination with Docetaxel, Carboplatin, and Trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.
Left Ventricular Dysfunction
: LVEF should be monitored and dosing should be withheld as appropriate.
Embryo-fetal toxicity
: Fetal harm can occur when administered to a pregnant woman.
Infusion-Related Reactions
: Should be monitored for signs and symptoms. If a significant infusion-associated reaction occurs, the infusion should be slowed or interrupted and appropriate medical therapies should be administered.
Hypersensitivity Reactions/Anaphylaxis
: Should be monitored for signs and symptoms. If a severe hypersensitivity reaction/anaphylaxis occurs, the infusion should be discontinued immediately and appropriate medical therapies should be administered.
Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2) and, thereby, blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3, and HER4. As a result, Pertuzumab inhibits ligand-initiated intracellular signaling through two major signal pathways, mitogen-activated protein (MAP) kinase, and phosphoinositide 3-kinase (PI3K). Inhibition of these signaling pathways can result in cell growth arrest and apoptosis, respectively. In addition, Pertuzumab mediates antibody-dependent cell-mediated cytotoxicity.