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PERJETA
Overview
What is PERJETA?
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 is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture that may contain the antibiotic, gentamicin. Gentamicin is not detectable in the final product. Pertuzumab has an approximate molecular weight of 148 kDa.
PERJETA injection is a sterile, clear to slightly opalescent, colorless to pale brown liquid for intravenous infusion. Each single use vial contains 420 mg of pertuzumab at a concentration of 30 mg/mL in 20 mM L-histidine acetate (pH 6.0), 120 mM sucrose and 0.02% polysorbate 20.
What does PERJETA look like?
What are the available doses of PERJETA?
Injection: 420 mg/14 mL (30 mg/mL) in a single-dose vial
What should I talk to my health care provider before I take PERJETA?
Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of PERJETA. ()
How should I use PERJETA?
PERJETA is indicated for use in combination with 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 .
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens . Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
What interacts with PERJETA?
Sorry No Records found
What are the warnings of PERJETA?
Sorry No Records found
What are the precautions of PERJETA?
Sorry No Records found
What are the side effects of PERJETA?
Sorry No records found
What should I look out for while using PERJETA?
PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients.
What might happen if I take too much PERJETA?
Sorry No Records found
How should I store and handle PERJETA?
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.Keep vial in the outer carton in order to protect from light.DO NOT FREEZE. DO NOT SHAKE.Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.Keep vial in the outer carton in order to protect from light.DO NOT FREEZE. DO NOT SHAKE.Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.Keep vial in the outer carton in order to protect from light.DO NOT FREEZE. DO NOT SHAKE.Product: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-0794NDC: 50090-0794-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-1 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-0794-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50090-2257NDC: 50090-2257-0 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-1 100 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50090-2257-3 60 TABLET, EXTENDED RELEASE in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 (ADCC).
While pertuzumab alone inhibited the proliferation of human tumor cells, the combination of pertuzumab and trastuzumab augmented anti-tumor activity in HER2-overexpressing xenograft models.
Non-Clinical Toxicology
PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients.Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors
Decreases in LVEF have been reported with drugs that block HER2 activity, including PERJETA. Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered ].
In CLEOPATRA, for patients with MBC, PERJETA in combination with trastuzumab and docetaxel was not associated with increases in the incidence of symptomatic left ventricular systolic dysfunction (LVSD) or decreases in LVEF compared with placebo in combination with trastuzumab and docetaxel . Left ventricular dysfunction occurred in 4% of patients in the PERJETA-treated group and 8% of patients in the placebo-treated group. Symptomatic left ventricular systolic dysfunction (congestive heart failure) occurred in 1% of patients in the PERJETA-treated group and 2% of patients in the placebo-treated group . Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF.
In patients receiving neoadjuvant treatment in NeoSphere, the incidence of LVSD was higher in the PERJETA-treated groups compared to the trastuzumab- and docetaxel-treated group. An increased incidence of LVEF declines was observed in patients treated with PERJETA in combination with trastuzumab and docetaxel. In the overall treatment period, LVEF decline > 10% and a drop to less than 50% occurred in 2% of patients treated with neoadjuvant trastuzumab and docetaxel as compared to 8% of patients treated with neoadjuvant PERJETA in combination with trastuzumab and docetaxel. Left ventricular dysfunction occurred in 0.9% of patients treated with neoadjuvant trastuzumab and docetaxel as compared to 3% of patients treated with neoadjuvant PERJETA in combination with trastuzumab and docetaxel. Symptomatic LVSD occurred in 0.9% of patients treated with neoadjuvant PERJETA in combination with trastuzumab and no patients in the other 3 arms. LVEF recovered to ≥ 50% in all patients.
In patients receiving neoadjuvant PERJETA in TRYPHAENA, in the overall treatment period, LVEF decline > 10% and a drop to less than 50% occurred in 7% of patients treated with PERJETA plus trastuzumab and FEC followed by PERJETA plus trastuzumab and docetaxel, 16% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC, and 11% of patients treated with PERJETA in combination with TCH. Left ventricular dysfunction occurred in 6% of patients treated with PERJETA plus trastuzumab and FEC followed by PERJETA plus trastuzumab and docetaxel, 4% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC, and 3% of patients treated with PERJETA in combination with TCH. Symptomatic LVSD occurred in 4% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC, 1% of patients treated with PERJETA in combination with TCH, and none of the patients treated with PERJETA plus trastuzumab and FEC followed by PERJETA plus trastuzumab and docetaxel. LVEF recovered to ≥ 50% in all but one patient.
In patients receiving neoadjuvant PERJETA in BERENICE, in the neoadjuvant period, LVEF decline ≥ 10% and a drop to less than 50% as measured by ECHO/MUGA assessment occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC, and 2% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC. Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period. Symptomatic LVSD (NYHA Class III/IV Congestive Heart Failure) occurred in 2% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and none of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period.
In patients receiving adjuvant PERJETA in APHINITY, the incidence of symptomatic heart failure (NYHA Class III/IV) with a LVEF decline ≥ 10% and a drop to less than 50% was <1% (0.6% of PERJETA-treated patients vs. 0.2% of placebo-treated patients). Of the patients who experienced symptomatic heart failure, 47% of PERJETA-treated patients and 67% of placebo-treated patients had recovered (defined as 2 consecutive LVEF measurements above 50%) at the data cutoff. The majority of the events (86%) were reported in anthracycline-treated patients. Asymptomatic or mildly symptomatic (NYHA Class II) declines in LVEF ≥ 10% and a drop to less than 50% were reported in 3% of PERJETA-treated patients and 3% of placebo-treated patients, of whom 80% of PERJETA-treated patients and 81% of placebo-treated patients recovered at the data cutoff.
PERJETA has not been studied in patients with a pretreatment LVEF value of ≤ 50%, a prior history of CHF, decreases in LVEF to < 50% during prior trastuzumab therapy, or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360 mg/m of doxorubicin or its equivalent.
The following adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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