Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Phesgo

Last reviewed on RxList: 10/13/2020
Phesgo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Phesgo?

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is a combination of HER2/neu receptor antagonists and an endoglycosidase indicated for use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; and adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence Phesgo is also indicated for use in combination with 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.

What Are Side Effects of Phesgo?

Side effects of Phesgo include:

Dosage for Phesgo

The initial dose of Phesgo is 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase administered subcutaneously over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase administered subcutaneously over approximately 5 minutes.

Phesgo In Children

The safety and effectiveness of Phesgo in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Phesgo?

Phesgo may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Phesgo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Phesgo; it may harm a fetus. The pregnancy status of females of reproductive potential should be verified prior to the initiation of Phesgo. Females of reproductive potential are advised to use effective contraception during treatment and for 7 months following the last dose of Phesgo. If Phesgo is administered during pregnancy, or if a patient becomes pregnant while receiving Phesgo or within 7 months following the last dose of Phesgo, health care providers and patients should immediately report Phesgo exposure to Genentech at 1-888-835-2555. It is unknown if Phesgo passes into breast milk or how it could affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Phesgo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, rash; fever, chills, dizziness; nausea, vomiting, diarrhea; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine can cause life-threatening heart or lung problems. Call your doctor at once if you have:

  • a new or worsening cough or shortness of breath (even while at rest);
  • fast or pounding heartbeats;
  • severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your face or lower legs;
  • rapid weight gain (more than 5 pounds in 24 hours);
  • a light-headed feeling, like you might pass out;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, diarrhea;
  • anemia;
  • feeling weak or tired;
  • hair loss;
  • rash; or
  • numbness, tingling, or burning pain in your hands or feet.

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.

Read the entire detailed patient monograph for Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection)

QUESTION

A lump in the breast is almost always cancer. See Answer
Phesgo Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Cardiomyopathy [see WARNINGS AND PRECAUTIONS]
  • Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
  • Exacerbation of Chemotherapy-Induced Neutropenia [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity and Administration-Related Reactions [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 practice.

Neoadjuvant And Adjuvant Treatment Of Breast Cancer

The safety of PHESGO was evaluated in an open-label, multicenter, randomized study (FeDeriCa) conducted in 500 patients with HER2 overexpressing early breast cancer [see Clinical Studies].

Patients were randomized to receive either PHESGO (1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase/15 mL) followed every 3 weeks by a maintenance dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase/10 mL or the recommended dosages for intravenous pertuzumab and intravenous trastuzumab. Patients were randomized to receive 8 cycles of neoadjuvant chemotherapy with concurrent administration of 4 cycles of either PHESGO or intravenous pertuzumab and trastuzumab during cycles 5-8, followed by surgery. Following surgery, patients continued therapy with PHESGO or intravenous pertuzumab and trastuzumab (intravenous or subcutaneously administered) as treated prior to surgery, for an additional 14 cycles, to complete 18 cycles. The median duration of treatment for PHESGO was 24 weeks (range: 0-42 weeks).

Serious adverse reactions occurred in 16% of patients who received PHESGO. Serious adverse reactions in > 1% of patients included febrile neutropenia (4%), neutropenic sepsis (1%), and neutrophil count decreased (1%). One fatal adverse reaction occurred in 1/248 (0.4%) of patients, which was due to acute myocardial infarction, and occurred prior to the start of HER2 targeted treatment with PHESGO.

Adverse reactions resulting in permanent discontinuation of any study drug occurred in 8% of patients on the PHESGO arm. Adverse reactions which resulted in permanent discontinuation of PHESGO were ejection fraction decreased (1.2%), cardiac failure (0.8%), and pneumonitis/pulmonary fibrosis (0.8%).

Dosage interruptions due to an adverse reaction occurred in 40% of patients who received PHESGO. Adverse reactions which required dosage interruption in > 1% of patients who received PHESGO included neutropenia (8%), neutrophil count decreased (4%), and diarrhea (7%).

Tables 3 summarizes the adverse reactions in FeDeriCa.

Table 3: Adverse Reactions (≥ 5%) in Patients Who Received PHESGO in FeDeriCa

Body System/Adverse ReactionsPHESGO
(n=248)
Intravenous pertuzumab plus intravenous or subcutaneous trastuzumab
(n=252)
All Grades
%
Grades 3 – 4
%
All Grades
%
Grades 3 – 4
%
Skin and subcutaneous tissue disorders
Alopecia770710.4
Dry skin150.4130
Rash160.4210
Nail discoloration9060
Erythema9050
Dermatitis7060
Nail disorder7070.4
Palmar-plantar erythrodysesthesia syndrome60.850.4
Gastrointestinal disorders
Nausea602611.6
Diarrhea607574.8
Stomatitis250.8240.8
Constipation220210
Vomiting200.8191.2
Dyspepsia140120
Hemorrhoids904.00
Abdominal pain upper8060
Abdominal pain90.460
Blood and lymphatic system disorders
Anemia361.6434.4
Neutropenia22142714
Leukopenia92.4142
Febrile neutropenia7766
General disorders and administration site conditions
Asthenia310.4322.4
Fatigue292242
Mucosal inflammation150.8201.2
Injection site reaction1500.80
Pyrexia130160.4
Edema peripheral80100
Malaise7060.4
Influenza-like illness503.60
Nervous system disorders
Dysgeusia170140
Peripheral sensory neuropathy160.8140.4
Headache170250.8
Neuropathy peripheral120.4152
Paresthesia100.880
Dizziness130110
Investigations
Weight decreased110.860.8
Musculoskeletal and connective tissue disorders
Myalgia250.4190.4
Arthralgia240280.4
Back pain1004.80
Bone pain7050
Pain in extremity6080
Muscle spasms6070
Musculoskeletal pain60.480
Respiratory, thoracic and mediastinal disorder
Cough150.4130
Epistaxis120140.4
Dyspnea101.250
Rhinorrhea704.40
Infections and infestations
Upper respiratory tract infection11080.8
Nasopharyngitis90100
Paronychia70.43.60
Urinary tract infection70.450
Injury, poisoning and procedural complications
Procedural pain130100
Radiation skin injury190.4190.4
Infusion related reaction3.60150.8
Metabolism and nutrition disorders
Decreased appetite170.8190.4
Hypokalemia71.680
Psychiatric disorders
Insomnia170130.4
Eye disorders
Lacrimation increased50.460
Dry eye50.43.20
Vascular disorders
Hot flush120130

Clinically relevant adverse reactions in < 5% of patients who received PHESGO include ejection fraction decreased (3.6%) and pruritus (3.2%).

Table 4 summarizes the laboratory abnormalities in FeDeriCa.

Table 4: Select Laboratory Abnormalities (≥5%) that Worsened from Baseline in Patients Who Received PHESGO in FeDeriCa 1

Laboratory AbnormalityPHESGO
(n=248)
Intravenous pertuzumab plus intravenous or subcutaneous trastuzumab
(n=252)
All Grades
%
Grades 3 – 4
%
All Grades
%
Grades 3 – 4
%
Hematology
Hemoglobin (low)902.8924.4
Lymphocytes, Absolute (low)89378836
Total Leukocyte Count (low)82257825
Neutrophils, Total Absolute (low)68306733
Platelet (low)270280.4
Chemistry
Creatinine (high)840870.4
Alanine aminotransferase (high)581.6682.4
Aspartate aminotransferase (high)500.8580.8
Potassium (low)175.2172.8
Albumin (low)160200.4
Potassium (high)131.290
Sodium (low)130.4101.6
Bilirubin (high)9090.4
Glucose (low)9090.4
Sodium (high)70.8100.8
1 The denominator used to calculate the rate varied from 163 to 252 based on the number of patients with a baseline value and at least one post-treatment value.

Other Clinical Trials Experience

The safety of the addition of intravenous pertuzumab to trastuzumab in combination with chemotherapy has been established in studies conducted in patients with HER2 overexpressing early breast cancer. The following adverse reactions have been reported following administration of intravenous pertuzumab and trastuzumab: diarrhea, alopecia, nausea, fatigue, neutropenia, vomiting, peripheral neuropathy, constipation, anemia, asthenia, mucosal inflammation, myalgia, and thrombocytopenia. Refer to the Prescribing Information for pertuzumab for more information.

The safety of intravenous pertuzumab, trastuzumab and docetaxel has been established in patients with HER2 overexpressing metastatic breast cancer. The following adverse reactions have been reported following administration of intravenous pertuzumab and trastuzumab: diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. Refer to the Prescribing Information for pertuzumab for more information.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity with PHESGO. 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 PHESGO and intravenous pertuzumab and trastuzumab in the FeDeriCa study with the incidence of antibodies in other studies or to other products may be misleading.

In the FeDeriCa study, the incidence of treatment-emergent anti-pertuzumab and anti-trastuzumab antibodies in most patients completing 1-4 cycles of therapy was 3% (7/237) and 0.4% (1/237), respectively, in patients treated with intravenous pertuzumab and trastuzumab. The incidence of treatment-emergent anti-pertuzumab, anti-trastuzumab, and anti-recombinant human hyaluronidase PH20 antibodies in most patients completing 1-4 cycles of therapy was 4.8% (11/231), 0.9% (2/232), and 0.9% (2/225), respectively, in patients treated with PHESGO. Among patients who tested positive to anti-pertuzumab antibodies, neutralizing anti-pertuzumab antibodies were detected in one patient treated with intravenous pertuzumab and trastuzumab and in one patient treated with PHESGO. Among patients who tested positive to anti-trastuzumab antibodies, neutralizing anti-trastuzumab antibodies were detected in one patient treated with PHESGO.

The clinical relevance of the development of anti-pertuzumab, anti-trastuzumab or anti-recombinant human hyaluronidase PH20 antibodies after treatment with PHESGO is unknown.

Postmarketing Experience

The following adverse reactions have been identified with the use of intravenous pertuzumab and trastuzumab. 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.

  • Glomerulopathy
  • Immune thrombocytopenia
  • Tumor lysis syndrome (TLS): 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.

Read the entire FDA prescribing information for Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection)

Related Resources for Phesgo

© Phesgo Patient Information is supplied by Cerner Multum, Inc. and Phesgo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW