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Perjeta Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Perjeta FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in greater detail in other sections of the label:
- Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
- Left Ventricular Dysfunction [see WARNINGS AND PRECAUTIONS]
- Infusion-Associated Reactions, Hypersensitivity Reactions/Anaphylaxis [see WARNINGS AND PRECAUTIONS]
Clinical 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.
In clinical trials, PERJETA has been evaluated in more than 1400 patients with various malignancies and treatment with PERJETA was predominantly in combination with other anti-neoplastic agents.
The adverse reactions described in Table 1 were identified in 804 patients with HER2-positive metastatic breast cancer treated in the randomized trial. Patients were randomized to receive either PERJETA in combination with trastuzumab and docetaxel or placebo in combination with trastuzumab and docetaxel. The median duration of study treatment was 18.1 months for patients in the PERJETA-treated group and 11.8 months for patients in the placebo-treated group. No dose adjustment was permitted for PERJETA or trastuzumab. The rates of adverse events resulting in permanent discontinuation of all study therapy were 6.1% for patients in the PERJETA-treated group and 5.3% for patients in the placebo-treated group. Adverse events led to discontinuation of docetaxel alone in 23.6% of patients in the PERJETA-treated group and 23.2% of patients in the placebo-treated group. Table 1 reports the adverse reactions that occurred in at least 10% of patients in the PERJETA-treated group.
The most common adverse reactions ( > 30%) seen with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. The most common NCI - CTCAE (version 3) Grade 3 - 4 adverse reactions ( > 2%) were neutropenia, febrile neutropenia, leukopenia, diarrhea, peripheral neuropathy, anemia, asthenia, and fatigue. An increased incidence of febrile neutropenia was observed for Asian patients in both treatment arms compared with patients of other races and from other geographic regions. Among Asian patients, the incidence of febrile neutropenia was higher in the pertuzumab-treated group (26%) compared with the placebo-treated group (12%).
Table 1 : Summary of Adverse Reactions Occurring in ≥ 10%
of Patients on the PERJETA Treatment Arm in the Randomized Trial
|Body System/Adverse Reactions||PERJETA + trastuzumab + docetaxel
Frequency rate %
|Placebo + trastuzumab + docetaxel
Frequency rate %
|All Grades %||Grades 3 - 4 %||All Grades %||Grades 3 - 4 %|
|General disorders and administration site conditions|
|Skin and subcutaneous tissue disorders|
|Blood and lymphatic system disorders|
|Nervous system disorders|
|Musculoskeletal and connective tissue disorders|
|Infections and infestations|
|Upper respiratory tract infection||16.7||0.7||13.4||0.0|
|Respiratory, thoracic and mediastinal disorders|
|Metabolism and nutrition disorders|
|*In this table this denotes an adverse reaction that has been reported in association with a fatal outcome|
The following clinically relevant adverse reactions were reported in < 10% of patients in the PERJETA-treated group:
Skin and subcutaneous tissue disorders: Paronychia (7.1% in the PERJETA-treated group vs. 3.5% in the placebo-treated group)
Respiratory, thoracic and mediastinal disorders: Pleural effusion (5.2% in the PERJETA- treated group vs. 5.8% in the placebo-treated group)
Cardiac disorders: Left ventricular dysfunction (4.4% in the PERJETA-treated group vs. 8.3% in the placebo-treated group) including symptomatic left ventricular systolic dysfunction (CHF) (1.0% in the PERJETA-treated group vs. 1.8% in the placebo-treated group)
Immune system disorders: Hypersensitivity (10.1% in the PERJETA-treated group vs. 8.6% in placebo-treated group)
Adverse Reactions Reported in Patients Receiving PERJETA and Trastuzumab after Discontinuation of Docetaxel
In the randomized trial, adverse reactions were reported less frequently after discontinuation of docetaxel treatment. All adverse reactions in the PERJETA and trastuzumab treatment group occurred in < 10% of patients with the exception of diarrhea (19.1%), upper respiratory tract infection (12.8%), rash (11.7%), headache (11.4%), and fatigue (11.1%).
As with all therapeutic proteins, there is the potential for an immune response to PERJETA.
Patients in the randomized trial were tested at multiple time-points for antibodies to PERJETA. Approximately 2.8% (11/386) of patients in the PERJETA-treated group and 6.2% (23/372) of patients in the placebo-treated group tested positive for anti-PERJETA antibodies. Of these 34 patients, none experienced anaphylactic/hypersensitivity reactions that were clearly related to the anti-therapeutic antibodies (ATA). The presence of pertuzumab in patient serum at the levels expected at the time of ATA sampling can interfere with the ability of this assay to detect anti- pertuzumab antibodies. In addition, the assay may be detecting antibodies to trastuzumab. As a result, data may not accurately reflect the true incidence of anti-pertuzumab antibody development.
Immunogenicity data are highly dependent on the sensitivity and specificity of the test methods used. Additionally, the observed incidence of a positive result in a test method may be influenced by several factors, including sample handling, timing of sample collection, drug interference, concomitant medication, and the underlying disease. For these reasons, comparison of the incidence of antibodies to PERJETA with the incidence of antibodies to other products may be misleading.
Read the entire FDA prescribing information for Perjeta (Pertuzumab) »
Additional Perjeta Information
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