Does Perjeta (pertuzumab) cause side effects?

Perjeta (pertuzumab) is a monoclonal antibody used to treat breast cancer that has spread beyond the breast (metastasized).

The cells of cancers have various receptors on their surfaces. Chemicals bind to these receptors and cause changes within the cancer cells. One of the receptors that occurs in about one-third of all breast cancers is called HER2, which is known to control the growth and development of the cancer cells and the production of new cancer cells.

If HER2 receptors are present in large numbers on the cancer cells, then the cancer cells may multiply and grow quickly. Normally, the immune system produces antibodies that will detect and attack HER2 receptors to slow the growth of cancer cells.

However, if HER2 is present in large amounts, the immune system may be unable to control HER2. Perjeta is thought to block the HER2 receptors when there is overexpression, thereby blocking growth of the cancer. 

Common side effects of Perjeta include

Serious side effects of Perjeta include

The manufacturer has not identified any Perjeta drug interactions.

Perjeta can cause fetal harm when administered to pregnant women and should not be administered during pregnancy.

It is unknown if Perjeta is excreted in human milk. Breastfeeding mothers should decide whether to stop nursing or discontinue Perjeta.

What are the important side effects of Perjeta (pertuzumab)?

Common side effects of pertuzumab include:

Pertuzumab also causes heart failure, infusion reactions, and serious allergic reactions. Treatment may also reduce the number of red blood cells (anemia), and reduce the number of platelets and white blood cells. A reduced number of white blood cells increases the risk for febrile neutropenia and infections.

Perjeta (pertuzumab) side effects list for healthcare professionals

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

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.

Metastatic Breast Cancer (MBC)

The adverse reactions described in Table 2 were identified in 804 patients with HER2-positive metastatic breast cancer treated in CLEOPATRA. 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.

Adverse reactions resulting in permanent discontinuation of all study therapy were 6% in the Perjeta-treated group and 5% for patients in the placebo-treated group.

The most common adverse reactions (>1%) that led to discontinuation of all study therapy was left ventricular dysfunction (1% for patients in the Perjeta-treated group and 2% for patients in the placebo-treated group).

The most common adverse reactions that led to discontinuation of docetaxel alone were

Table 2 reports the adverse reactions that occurred in at least 10% of patients in the Perjetatreated group. The safety profile of Perjeta remained unchanged with an additional 2.75 years of follow-up (median total follow-up of 50 months) in CLEOPATRA.

The most common adverse reactions (> 30%) seen with Perjeta in combination with trastuzumab and docetaxel were

The most common NCI - CTCAE v3.0 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 2: Summary of Adverse Reactions Occurring in ≥ 10% of Patients on the Perjeta Treatment Arm in CLEOPATRA

Body System/ Adverse ReactionsPerjeta + trastuzumab + docetaxel
n=407
Frequency
rate %
Placebo + trastuzumab + docetaxel
n=397
Frequency
rate %
All Grades
%
Grades 3 – 4
%
All Grades
%
Grades 3 – 4
%
General disorders and administration site conditions
Fatigue372373
Mucosal inflammation281201
Asthenia262302
Edema peripheral230.5300.8
Pyrexia191180.5
Skin and subcutaneous tissue disorders
Alopecia610600.3
Rash340.7240.8
Nail disorder231230.3
Pruritus140100
Dry skin11040
Gastrointestinal disorders
Diarrhea678465
Nausea421420.5
Vomiting241242
Stomatitis190.5150.3
Constipation150251
Blood and lymphatic system disorders
Neutropenia53495046
Anemia232194
Leukopenia18122015
Febrile neutropenia*141387
Nervous system disorders
Neuropathy peripheral323342
Headache211170.5
Dysgeusia180160
Dizziness130.5120
Musculoskeletal and connective tissue disorders
Myalgia231240.8
Arthralgia150.2160.8
Infections and infestations
Upper respiratory tract infection170.7130
Nasopharyngitis120130.3
Respiratory, thoracic, and mediastinal disorders
Dyspnea141162
Metabolism and nutrition disorders
Decreased appetite292262
Eye disorders
Lacrimation increased140140
Psychiatric disorders
Insomnia130130
* 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 in CLEOPATRA:

Infections and Infestations

Paronychia (7% in the Perjeta-treated group vs. 4% in the placebo-treated group)

Adverse Reactions Reported in Patients Receiving Perjeta and Trastuzumab After Discontinuation of Docetaxel

In CLEOPATRA, 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%), upper respiratory tract infection (13%), rash (12%), headache (11%), and fatigue (11%).

Neoadjuvant Treatment Of Breast Cancer (NeoSphere)

In NeoSphere, the most common adverse reactions seen with Perjeta in combination with trastuzumab and docetaxel administered for 4 cycles were similar to those seen in the Perjetatreated group in CLEOPATRA.

The most common adverse reactions (> 30%) were

  • alopecia,
  • neutropenia,
  • diarrhea, and
  • nausea.

The most common NCI – CTCAE v3.0 Grade 3 – 4 adverse reactions (> 2%) were

  • neutropenia,
  • febrile neutropenia,
  • leukopenia, and
  • diarrhea.

In this group, one patient permanently discontinued neoadjuvant treatment due to an adverse event. Table 3 reports the adverse reactions that occurred in patients who received neoadjuvant treatment with Perjeta for breast cancer in NeoSphere.

Table 3 Summary of Adverse Reactions Occurring in ≥ 10% in the Neoadjuvant Setting for Patients Receiving Perjeta in NeoSphere

 
Body System/ Adverse ReactionsTrastuzumab + docetaxel
n=107
Frequency rate
%
Perjeta + trastuzumab + docetaxel
n=107
Frequency rate
%
Perjeta + trastuzumab
n=108
Frequency rate
%
Perjeta + docetaxel
n=108
Frequency rate
%
All Grades
%
Grades 3 – 4 %All Grades
%
Grades 3 – 4
%
All Grades
%
Grades 3 – 4
%
All Grades
%
Grades 3 – 4
%
General disorders and administration site conditions
Fatigue270260.9120261
Mucosal inflammation21026230260
Asthenia18021230162
Pyrexia1001708090
Edema peripheral100300.9050
Skin and subcutaneous tissue disorders
Alopecia66065030670
Rash212260.9110291
Gastrointestinal disorders
Diarrhea344466280544
Nausea360390140361
Stomatitis7018050100
Vomiting12013050162
Blood and lymphatic system disorders
Neutropenia645950450.90.96557
Leukopenia21119500149
Nervous system disorders
Dysgeusia1001505070
Headache110110140130
Peripheral Sensory Neuropathy120.980.920110
Musculoskeletal and connective tissue disorders
Myalgia22022090210
Arthralgia8010050100
Metabolism and nutrition disorders
Decreased appetite7014020150
Psychiatric disorders
Insomnia110804090

The following adverse reactions were reported in < 10% of patients receiving neoadjuvant treatment and occurred more frequently in Perjeta-treated groups in NeoSphere: (Ptz=pertuzumab; H=trastuzumab; D=docetaxel)

Blood and Lymphatic System Disorders

Anemia (7% in the H+D arm, 3% in the Ptz+H+D arm, 5% in the Ptz+H arm and 9% in the Ptz+D arm), Febrile neutropenia (7% in the H+D arm, 8% in the Ptz+H+D arm, 0% in the Ptz+H arm and 7% in the Ptz+D arm)

Nervous System Disorders

Dizziness (4% in the H+D arm, 3% in the Ptz+H+D arm, 6% in the Ptz+H arm and 3% in the Ptz+D arm)

Infections and Infestations

Upper respiratory tract infection (3% in the H+D arm, 5% in the Ptz+H+D arm, 2% in the Ptz+H arm and 7% in the Ptz+D arm)

Eye Disorders

Lacrimation increased (2% in the H+D arm, 4% in the Ptz+H+D arm, 0.9% in the Ptz+H arm, and 4% in the Ptz+D arm)

Neoadjuvant Treatment Of Breast Cancer (TRYPHAENA)

In TRYPHAENA, when Perjeta was administered in combination with trastuzumab and docetaxel for 3 cycles following 3 cycles of FEC, the most common adverse reactions (> 30%) were

  • diarrhea,
  • nausea,
  • alopecia,
  • neutropenia,
  • vomiting, and
  • fatigue.

The most common NCICTCAE (version 3) Grade 3 – 4 adverse reactions (> 2%) were

  • neutropenia,
  • leukopenia,
  • febrile neutropenia,
  • diarrhea,
  • left ventricular dysfunction,
  • anemia,
  • dyspnea,
  • nausea, and
  • vomiting.

Similarly, when Perjeta was administered in combination with docetaxel, carboplatin, and trastuzumab (TCH) for 6 cycles, the most common adverse reactions (> 30%) were

  • diarrhea,
  • alopecia,
  • neutropenia,
  • nausea,
  • fatigue,
  • vomiting,
  • anemia, and
  • thrombocytopenia.

The most common NCI-CTCAE (version 3) Grade 3 – 4 adverse reactions (> 2%) were

  • neutropenia,
  • febrile neutropenia,
  • anemia,
  • leukopenia,
  • diarrhea,
  • thrombocytopenia,
  • vomiting,
  • fatigue,
  • ALT increased,
  • hypokalemia, and
  • hypersensitivity.

Adverse reactions resulting in permanent discontinuation of any component of neoadjuvant treatment occurred in 7% of patients receiving Perjeta in combination with trastuzumab and docetaxel following FEC, and 8% for patients receiving Perjeta in combination with TCH.

The most common adverse reactions (>2%) resulting in permanent discontinuation of Perjeta were

  • left ventricular dysfunction,
  • drug hypersensitivity, and
  • neutropenia.

Table 4 reports the adverse reactions that occurred in patients who received neoadjuvant treatment with Perjeta for breast cancer in TRYPHAENA.

Table 4: Summary of Adverse Reactions Occurring in ≥ 10% of Patients Receiving Neoadjuvant Treatment with Perjeta in TRYPHAENA

Body System/Adverse ReactionsPerjeta + trastuzumab + FEC followed by Perjeta + trastuzumab + docetaxelvPerjeta + trastuzumab + docetaxel following FECPerjeta + TCH
n=72n=75n=76
Frequency rate
%
Frequency rate
%
Frequency rate
%
All Grades
%
Grades 3 – 4
%
All Grades
%
Grades 3 – 4
%
All Grades
%
Grades 3 – 4
%
General disorders and administration site conditions
Fatigue36036004
Mucosal inflammation240200171
Pyrexia17090160
Asthenia100151131
Edema peripheral1104090
Skin and subcutaneous tissue disorders
Alopecia490520550
Rash190110211
Palmar-Plantar Erythrodysaesthesia Syndrome7011080
Dry skin6090110
Gastrointestinal disorders
Diarrhea6146157212
Nausea530533450
Vomiting400363395
Dyspepsia25180220
Constipation180230160
Stomatitis140170120
Blood and lymphatic system disorders
Neutropenia514747434946
Leukopenia221916121712
Anemia191943817
Febrile neutropenia1818991717
Thrombocytopenia`70103012
Immune system disorders
Hypersensitivity10310123
Nervous system disorders
Headache220150170
Dysgeusia110130210
Dizziness8081160
Neuropathy peripheral6010110
Musculoskeletal and connective tissue disorders
Myalgia170111110
Arthralgia11012070
Respiratory, thoracic, and mediastinal disorders
Dyspnea13083111
Epistaxis110110161
Cough10050120
Oropharyngeal pain8070120
Metabolism and nutrition disorders
Decreased appetite210110210
Eye disorders
Lacrimation increased1305080
Psychiatric disorders
Insomnia110130210
Investigations
ALT increased7030114
FEC=5-fluorouracil, epirubicin, cyclophosphamide, TCH=docetaxel, carboplatin, trastuzumab

The following selected adverse reactions were reported in < 10% of patients receiving neoadjuvant treatment in TRYPHAENA: (Ptz=pertuzumab; H=trastuzumab; D=docetaxel; FEC= fluorouracil, epirubicin, and cyclophosphamide; TCH=docetaxel, carboplatin, and trastuzumab)

Skin and Subcutaneous Tissue Disorders

Nail disorder (10% in the Ptz+H+FEC/Ptz+H+D arm, 7% in the FEC/Ptz+H+D arm, and 9% in the Ptz+TCH arm), Paronychia (0% in the Ptz+H+FEC/Ptz+H+D arm, and 1% in both the FEC/Ptz+H+D and Ptz+TCH arms), Pruritus (3% in the Ptz+H+FEC/Ptz+H+D arm, 4% in the FEC/Ptz+H+D arm, and 4% in the Ptz+TCH arm)

Infections and Infestations

Upper respiratory tract infection (8.3% in the Ptz+H+FEC/Ptz+H+D arm, 4.0% in the FEC/Ptz+H+D arm, and 2.6% in the Ptz+TCH arm), Nasopharyngitis (6.9% in the Ptz+H+FEC/Ptz+H+D arm, 6.7% in the FEC/Ptz+H+D arm, and 7.9% in the Ptz+TCH arm)

Neoadjuvant Treatment Of Breast Cancer (BERENICE)

In BERENICE, when Perjeta was administered in combination with trastuzumab and paclitaxel for 4 cycles following 4 cycles of ddAC, the most common adverse reactions (> 30%) were

The most common Grade 3 – 4 adverse reactions (> 2%) were

  • neutropenia,
  • febrile neutropenia,
  • neutrophil count decreased,
  • white blood cell count decreased,
  • anemia,
  • diarrhea,
  • peripheral neuropathy,
  • alanine aminotransferase increased and
  • nausea.

When Perjeta was administered in combination with trastuzumab and docetaxel for 4 cycles following 4 cycles of FEC, the most common adverse reactions (> 30%) were

  • diarrhea,
  • nausea,
  • alopecia,
  • asthenia,
  • constipation,
  • fatigue,
  • mucosal inflammation,
  • vomiting,
  • myalgia, and
  • anemia.

The most common Grade 3 – 4 adverse reactions (> 2%) were

  • febrile neutropenia,
  • diarrhea,
  • neutropenia,
  • neutrophil count decreased,
  • stomatitis,
  • fatigue,
  • vomiting,
  • mucosal inflammation,
  • neutropenic sepsis and
  • anemia.

Adverse reactions resulting in permanent discontinuation of any component of neoadjuvant treatment were 14% for patients receiving Perjeta in combination with trastuzumab and paclitaxel following ddAC and 8% for patients receiving Perjeta in combination with trastuzumab and docetaxel following FEC.

The most common adverse reactions (>1%) resulting in permanent discontinuation of any component of neoadjuvant treatment were

  • neuropathy peripheral,
  • ejection fraction decreased,
  • diarrhea,
  • neutropenia and
  • infusion related reaction.

Table 5 reports the adverse reactions that occurred in patients who received neoadjuvant treatment with Perjeta for breast cancer in BERENICE.

Table 5: Summary of Adverse Reactions Occurring in ≥ 10% of Patients Receiving Neoadjuvant Treatment with Perjeta in BERENICE

Body System/Adverse ReactionsPerjeta + trastuzumab + paclitaxel following ddACPerjeta + trastuzumab + docetaxel following FEC
n=199n=198
Frequency rate
%
Frequency rate
%
All Grades
%
Grades
3 – 4
%
All Grades
%
Grades
3 – 4
%
General disorders and administration site conditions
Fatigue58115
Asthenia192410
Mucosal inflammation221374
Pyrexia150180
Edema peripheral90121
Skin and subcutaneous tissue disorders
Alopecia620590
Rash140110
Dry skin140100
Nail discoloration15020
Palmar-Plantar Erythrodysaesthesia Syndrome60100.5
Gastrointestinal disorders
Nausea713692
Diarrhea6736910
Constipation350.5380.5
Vomiting231354
Stomatitis250275
Dyspepsia190160
Abdominal pain upper60130
Abdominal pain50100
Gastroesophageal reflux disease12020
Blood and lymphatic system disorders
Anemia273303
Neutropenia2212169
Febrile neutropenia771717
Nervous system disorders
Headache300.5140.5
Dysgeusia200190.5
Neuropathy peripheral423260.5
Paresthesia15090
Dizziness12080
Musculoskeletal and connective tissue disorders
Myalgia200331
Arthralgia200211
Back pain10090
Pain in extremity10080
Bone pain120.550
Infections and infestations
Urinary tract infection11120
Respiratory, thoracic, and mediastinal disorders
Epistaxis250190
Dyspnea150.5150.5
Cough200.590
Oropharyngeal pain10080.5
Metabolism and nutrition disorders
Decreased appetite200230
Eye disorders
Lacrimation increased90180
Psychiatric disorders
Insomnia190130
Vascular disorders
Hot flush190130
Investigations
White blood cell count decreased11432
Injury, poisoning and procedural complications
Infusion related reaction161131
ddAC = dose-dense doxorubicin, cyclophosphamide, FEC=5-fluorouracil, epirubicin, cyclophosphamide

The following selected adverse reactions were reported in < 10% of patients receiving neoadjuvant treatment in BERENICE: (Ptz=pertuzumab; H=trastuzumab; P=paclitaxel; ddAC=dose-dense doxorubicin and cyclophosphamide; D=docetaxel; FEC= fluorouracil, epirubicin, and cyclophosphamide)

Skin and Subcutaneous Tissue Disorders

Pruritus (9% in the ddAC/Ptz+H+P arm, and 8% in the FEC/Ptz+H+D arm), Nail disorder (7% in the ddAC/Ptz+H+P arm, and 10% in the FEC/Ptz+H+D arm)

Infections and Infestations

Upper respiratory tract infection (7% in the ddAC/Ptz+H+P arm, and 2% in the FEC/Ptz+H+D arm), nasopharyngitis (7% in the ddAC/Ptz+H+P arm, and 9% in the FEC/Ptz+H+D arm), paronychia (0.5% in the ddAC/Ptz+H+P arm, and 1% in the FEC/Ptz+H+D arm)

Adjuvant Treatment Of Breast Cancer (APHINITY)

The adverse reactions described in Table 6 were identified in 4769 patients with HER2-positive early breast cancer treated in APHINITY. Patients were randomized to receive either Perjeta in combination with trastuzumab and chemotherapy or placebo in combination with trastuzumab and chemotherapy.

Adverse reactions resulting in permanent discontinuation of any study therapy were 13% for patients in the Perjeta-treated group and 12% for patients in the placebo-treated group. Adverse reactions resulting in permanent discontinuation of Perjeta or placebo was 7% and 6%, respectively.

The most common adverse reactions (>0.5%) resulting in permanent discontinuation of any study treatment were

  • ejection fraction decreased,
  • neuropathy peripheral,
  • diarrhea, and
  • cardiac failure.

Table 6 reports the adverse reactions that occurred in at least 10% of patients in the Perjeta-treated group.

When Perjeta was administered in combination with trastuzumab and chemotherapy, the most common adverse reactions (> 30%) were

  • diarrhea,
  • nausea,
  • alopecia,
  • fatigue,
  • peripheral neuropathy, and
  • vomiting.

The most common Grade 3 – 4 adverse reactions (> 2%) were

  • neutropenia,
  • febrile neutropenia,
  • diarrhea,
  • neutrophil count decreased,
  • anemia,
  • white blood cell count decreased,
  • leukopenia,
  • fatigue,
  • nausea, and
  • stomatitis.

The incidence of diarrhea, all Grades, was higher when chemotherapy was administered with targeted therapy (61% in the Perjeta-treated group vs. 34% in the placebo-treated group), and was higher when administered with non-anthracycline based therapy (85% in the Perjetatreated group vs. 62% in the placebo-treated group) than with anthracycline based therapy (67% in the Perjeta-treated group vs. 41% in the placebo-treated group).

The incidence of diarrhea during the period that targeted therapy was administered without chemotherapy was 18% in the Perjeta-treated group vs. 9% in the placebo-treated group.

The median duration of all Grades diarrhea was 8 days for the Perjeta-treated group vs. 6 days for the placebo-treated group. The median duration of Grade ≥3 diarrhea was 20 days for the Perjeta-treated group vs. 8 days for the placebo-treated group.

More patients required hospitalization for diarrhea as a serious adverse event in the Perjeta-treated group (2.4%) than in the placebo-treated group (0.7%).

Table 6: Summary of Adverse Reactions Occurring in ≥ 10% of Patients Receiving Adjuvant Treatment with Perjeta in APHINITY

Body System/ Adverse ReactionsPerjeta + trastuzumab + chemotherapy
n=2364
Frequency rate %
Placebo + trastuzumab + chemotherapy
n=2405
Frequency rate %
All Grades
%
Grades
3 – 4
%
All Grades
%
Grades
3 – 4
%
General disorders and administration site conditions
Fatigue494443
Mucosal inflammation232190.7
Asthenia211212
Pyrexia200.6200.7
Edema peripheral17000.2
Skin and subcutaneous tissue disorders
Alopecia67<0.167<0.1
Rash260.4200.2
Pruritus140.19<0.1
Dry skin130.111<0.1
Nail disorder120.2120.1
Gastrointestinal disorders
Diarrhea7110454
Nausea692652
Vomiting322302
Constipation290.5320.3
Stomatitis282241
Dyspepsia140140
Abdominal pain120.5110.6
Abdominal pain upper100.390.2
Blood and lymphatic system disorders
Anemia287235
Neutropenia25162316
Febrile neutropenia*12121111
Nervous system disorders
Dysgeusia260.122<0.1
Neuropathy peripheral331321
Headache220.3230.4
Paresthesia120.5100.2
Dizziness110110.2
Musculoskeletal and connective tissue disorders
Arthralgia290.9331
Myalgia260.9301
Pain in extremity100.2100.2
Infections and infestations
Nasopharyngitis13<0.1120.1
Respiratory, thoracic, and mediastinal disorders
Epistaxis18<0.1140
Cough16<0.115<0.1
Dyspnea120.4120.5
Metabolism and nutrition disorders
Decreased appetite240.8200.4
Vascular disorders
Hot flush200.2210.4
Eye disorders
Lacrimation increased13013<0.1
Psychiatric disorders
Insomnia170.317<0.1
Investigations
Neutrophil count decreased14101410
Injury, poisoning and procedural complications
Radiation skin injury130.3110.3
* In this table this denotes an adverse reaction that has been reported in association with a fatal outcome

For the adverse reactions that were reported in ≥10% of patients with at least 5% difference between the Perjeta-treated group and the placebo-treated group in APHINITY, the breakdown per chemotherapy regimen is provided: (Ptz=pertuzumab; H=trastuzumab; AC=anthracyclines; TCH=docetaxel, carboplatin, and trastuzumab)

Gastrointestinal Disorders

Diarrhea (67% in the Ptz+H+AC chemo arm, 85% in the Ptz+TCH arm, 41% in the Pla+H+AC chemo arm, 62% in the Pla+TCH arm)

Skin and Subcutaneous Disorders

Rash (26% in the Ptz+H+AC chemo arm, 25% in the Ptz+TCH arm, 21% in the Pla+H+AC chemo arm, 19% in the Pla+TCH arm), Pruritus (14% in the Ptz+H+AC chemo arm, 15% in the Ptz+TCH arm, 9% in the Pla+H+AC chemo arm, 9% in the Pla+TCH arm)

The following clinically relevant adverse reactions were reported in < 10% of patients in the Perjeta-treated group in APHINITY:

Blood and Lymphatic System Disorders

Leukopenia (9% in the Perjeta-treated group vs. 9% in the placebo-treated group)

Infections and Infestations

Upper respiratory tract infection (8% in the Perjeta-treated group vs. 7% in the placebo-treated group), paronychia (4% in the Perjeta-treated group vs. 2% in the placebo-treated group)

Adverse Reactions Reported in Patients Receiving Perjeta and Trastuzumab After Discontinuation of Chemotherapy

In the APHINITY study, during the targeted treatment alone phase, all adverse reactions in the Perjeta treatment group occurred in < 10% of patients with the exception of

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including

  • assay methodology,
  • sample handling,
  • timing of sample collection,
  • concomitant medications, and
  • underlying disease.

For these reasons, comparison of the incidence of antibodies to pertuzumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Patients in CLEOPATRA were tested at multiple time-points for antibodies to Perjeta.

  • 3% (13/389) of patients in the Perjeta-treated group and 7% (25/372) of patients in the placebotreated group tested positive for anti-Perjeta antibodies.
  • Of these 38 patients, none experienced anaphylactic/hypersensitivity reactions that were clearly related to the anti-drug antibodies (ADA).

The presence of pertuzumab in patient serum at the levels expected at the time of ADA 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.

In the neoadjuvant period of BERENICE, 0.3% (1/383) of patients treated with Perjeta tested positive for anti-Perjeta antibodies. This patient did not experience any anaphylactic/hypersensitivity reactions.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of Perjeta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Tumor lysis syndrome (TLS): Cases of possible TLS have been reported in patients treated with Perjeta. Patients with significant tumor burden (e.g., bulky metastases) may be at a higher risk. Patients could present with hyperuricemia, hyperphosphatemia, and acute renal failure which may represent possible TLS. Providers should consider additional monitoring and/or treatment as clinically indicated.

What drugs interact with Perjeta (pertuzumab)?

No drug-drug interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel, paclitaxel, or carboplatin.

Summary

Perjeta (pertuzumab) is a monoclonal antibody used to treat breast cancer that has spread beyond the breast (metastasized). Common side effects of Perjeta include diarrhea, nausea, vomiting, anemia, inflammation of the mouth and lips, reduced number of white blood cells, inflammation of mucus membranes in the digestive tract, rash, hair loss, weakness, itching, pain in extremities, and changes in sense of taste. Perjeta can cause fetal harm when administered to pregnant women and should not be administered during pregnancy. It is unknown if Perjeta is excreted in human milk.

Treatment & Diagnosis

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Medically Reviewed on 7/21/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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