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Phesgo is a brand name for Pertuzumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1) • the adjuvant treatment of adult patients with…
Verbatim from this product's EMA label. Tap a section to expand.
Phesgo should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents. Phesgo should be administered by a healthcare professional prepared to manage anaphylaxis and in an environment where full resuscitation facilities are immediately available.
g. 4). In order to prevent medication errors, it is important to check the vial label to ensure that the medicinal product being prepared and administered is Phesgo. Patients currently receiving intravenous pertuzumab and trastuzumab can switch to Phesgo.
1). Posology Patients treated with Phesgo must have HER2-positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) and/or a ratio of ≥ 2 by in situ hybridization (ISH), assessed by a validated test. To ensure accurate and reproducible results, the testing must be performed in a specialized laboratory, which can ensure validation of the testing procedures.
For full instructions on assay performance and interpretation, please refer to the package leaflet of validated HER2 testing assays. For Phesgo dose recommendations in early and metastatic breast cancer please refer to Table 1.
Table 1:
Phesgo recommended dosing and administration Dose (irrespective of body weight) Approximate duration of subcutaneous injection Observation time ab Loading dose 1 200 mg pertuzumab/ 600 mg trastuzumab 8 minutes 30 minutes Maintenance dose (every 3 weeks) 600 mg pertuzumab/ 600 mg trastuzumab 5 minutes 15 minutes aPatients should be observed for injection-related reactions and hypersensitivity reactions bObservation period should start following administration of Phesgo and be completed prior to any subsequent administration of chemotherapy In patients receiving a taxane, Phesgo should be administered prior to the taxane.
When administered with Phesgo, the recommended initial dose of docetaxel is 75 mg/m2 and subsequently escalated to 100 mg/m2 depending on the chosen regimen and tolerability of the initial dose. Alternatively, docetaxel can be given at 100 mg/m2 on a 3-weekly schedule from the start, again depending on the chosen regimen.
If a carboplatin-based regimen is used, the recommended dose for docetaxel is 75 mg/m2 throughout (no dose escalation). When administered with Phesgo in the adjuvant setting, the recommended dose of paclitaxel is 80 mg/m2 once weekly for 12 weekly cycles.
Summary of the safety profile The most common adverse drug reactions (ADRs) (≥ 30 %) reported in patients treated with Phesgo or intravenous pertuzumab in combination with trastuzumab and chemotherapy were alopecia, diarrhoea, nausea, anemia, asthenia and arthralgia.
The most common serious adverse events (SAE) (≥ 1 %) reported in patients treated with Phesgo or intravenous pertuzumab in combination with trastuzumab were febrile neutropenia, cardiac failure, pyrexia, neutropenia, neutropenic sepsis, neutrophil count decreased and pneumonia.
3 % vs. 4 %). In the pivotal trial FEDERICA, SAEs were equally distributed between the Phesgo treatment arm and the intravenous pertuzumab in combination with trastuzumab treatment arm. 1 % vs 6 %. Tabulated list of adverse reactions The safety of pertuzumab in combination with trastuzumab has been evaluated in 3 834 patients with HER2-positive breast cancers in the pivotal trials CLEOPATRA, NEOSPHERE, TRYPHAENA APHINITY and FEDERICA.
It was generally consistent across studies, although the incidence and most common ADRs varied depending on whether pertuzumab in combination with trastuzumab were administered with or without concomitant anti-neoplastic agent. Table 2 presents, in the first column, ADRs that have been reported in association with the use of pertuzumab in combination with trastuzumab and chemotherapy in the below mentioned pivotal clinical trials (n= 3 834) and in the post-marketing setting.
As pertuzumab is used in combination with trastuzumab and chemotherapy, it is difficult to ascertain the causal relationship of an adverse reaction to a particular medicinal product. The last two columns detail ADRs reported in the Phesgo arm of FEDERICA study (n=243) when Phesgo is administered with chemotherapy agent and as monotherapy.
• CLEOPATRA, in which pertuzumab was given in combination with trastuzumab and docetaxel to patients with metastatic breast cancer (n= 453) • NEOSPHERE (n= 309) and TRYPHAENA (n= 218), in which neoadjuvant pertuzumab was given in combination with trastuzumab and chemotherapy to patients with locally advanced, inflammatory or early breast cancer • APHINITY, in which adjuvant pertuzumab was given in combination with trastuzumab and anthracycline-based or non-anthracycline-based, taxane-containing chemotherapy to patients with early breast cancer (n= 2 364) • FEDERICA, in which Phesgo (n= 243) or intravenous pertuzumab and trastuzumab (n= 247) was firstly administered in combination with chemotherapy (neoadjuvant phase) and subsequently as monotherapy (adjuvant phase) to patients with early breast cancer.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Left ventricular dysfunction (including congestive heart failure) Decreases in LVEF have been reported with medicinal products that block HER2 activity, including pertuzumab and trastuzumab.
The incidence of symptomatic left ventricular systolic dysfunction (LVD [congestive heart failure]) was higher in patients treated with pertuzumab in combination with trastuzumab and chemotherapy compared to trastuzumab and chemotherapy.
8). Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of LVEF declines based on studies with intravenous pertuzumab in combination with trastuzumab and chemotherapy. Patients with history of serious cardiac illness or medical conditions, history of ventricular dysrhythmias or risk factors for ventricular dysrhythmias were excluded from the (neo-)adjuvant EBC pivotal trial FEDERICA with Phesgo.
Phesgo has not been studied in patients with: a pre-treatment LVEF value of < 55 % (EBC) or < 50 % (MBC); a prior history of congestive heart failure (CHF); 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/m2 of doxorubicin or its equivalent.
In addition, pertuzumab in combination with trastuzumab and chemotherapy has not been studied in patients with decreases in LVEF < 50 % during prior trastuzumab adjuvant therapy. g. once during neoadjuvant treatment and every 12 weeks in the adjuvant and metastatic setting) to ensure that LVEF is within normal limits.
2 and has not improved, or has declined further at the subsequent assessment, discontinuation of Phesgo should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. 7 Cardiac risk should be carefully considered and balanced against the medical need of the individual patient before use of Phesgo with an anthracycline.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). 4 Metastatic breast cancer Phesgo should be administered in combination with docetaxel. 4). 1). In the adjuvant setting, Phesgo should be administered for a total of one year (up to 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first), as part of a complete regimen for early breast cancer and regardless of the timing of surgery.
Treatment should include standard anthracycline- and/or taxane-based chemotherapy. Phesgo should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued. Delayed or missed doses If the time between two sequential injections is: • less than 6 weeks, the maintenance dose of Phesgo 600 mg/600 mg should be administered as soon as possible.
Thereafter, continue with the 3-weekly schedule. • 6 weeks or more, a loading dose of Phesgo 1 200 mg/600 mg should be re-administered followed by maintenance dose of Phesgo 600 mg/600 mg every 3 weeks thereafter. Dose modifications Dose reductions are not recommended for Phesgo.
Discontinuation of treatment with Phesgo may be needed at the discretion of the physician. Patients may continue therapy during periods of reversible chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
For docetaxel and other chemotherapy dose modifications, see relevant summary of product characteristics (SmPC). Left ventricular dysfunction Phesgo should be withheld for at least 3 weeks for any signs and symptoms suggestive of congestive heart failure.
4 for more details). Patients with metastatic breast cancer Patients should have a pre-treatment left ventricular ejection fraction (LVEF) of ≥ 50 %. Phesgo should be withheld for at least 3 weeks for: • a drop in LVEF to less than 40 % • a LVEF of 40 %-45 % associated with a fall of ≥ 10 % points below pre-treatment value.
Phesgo may be resumed if the LVEF has recovered to > 45 %, or to 40-45 % associated with a difference of < 10 % points below pre-treatment values. Patients with early breast cancer Patients should have a pre-treatment LVEF of ≥ 55 % (≥ 50 % after completion of the anthracycline component of chemotherapy, if given).
5 Phesgo should be withheld for at least 3 weeks for a drop in LVEF to less than 50 % associated with a fall of ≥ 10 % points below pre-treatment values. Phesgo may be resumed if the LVEF has recovered to ≥ 50 % or to a difference of < 10 % points below pre-treatment values.
Special populations Elderly No overall differences in efficacy of Phesgo were observed in patients ≥ 65 and < 65 years of age. No dose adjustment of […]
These ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency: • Very common (≥ 1/10) • Common (≥ 1/100 to < 1/10) • Uncommon (≥ 1/1 000 to < 1/100) • Rare (≥ 1/10 000 to < 1/1 000) • Very rare (< 1/10 000) 12 • Not known (cannot be estimated from the available data) Within each frequency grouping and SOC, ADRs are presented in the order of decreasing seriousness.
Table 2 Summary of ADRs in patients treated with pertuzumab, trastuzumab in pivotal clinical trials^, ^^, and in the post-marketing setting† N = 3 834^ N = 243^^ Pertuzumab+trastuzumab Phesgo with chemotherapy Phesgo monotherapy ADR (MedDRA preferred term) System Organ Class Frequency category Frequency category Frequency category Blood and lymphatic system disorders Neutropenia Very common Very common Common Anemia Very common Very common Common Febrile neutropenia* Very common Common Not known Leukopenia Very common Common Common Cardiac disorders Left ventricular dysfunction** Common Uncommon Uncommon Cardiac failure** Common Uncommon Common Eye disorders Lacrimation increased Very common Common Uncommon Gastrointestinal disorders Diarrhea Very common Very common Very common Nausea Very common Very common Common Vomiting Very common Very common Common Stomatitis Very common Very common Common Constipation Very common Very common Common Dyspepsia Very common Very common Common 13 N = 3 834^ N = 243^^ Pertuzumab+trastuzumab Phesgo with chemotherapy Phesgo monotherapy Abdominal pain Very common Common Common General disorders and administration site conditions Fatigue Very common Very common Common Mucosal inflammation Very common Very common Uncommon Asthenia Very common Very common Very common Pyrexia Very common Common Common Edema peripheral Very common Common Common Injection site reaction°°° Very common Common Very common Immune system disorders Hypersensitivity*° Common Uncommon Not known Drug hypersensitivity*° Common Uncommon Uncommon Anaphylactic reaction*° Uncommon Not known Not known Cytokine release syndrome° Rare Not known Not known Infections and infestations Nasopharyngitis Very common Common Common Upper respiratory tract infection Common Common Common Paronychia Common Common Common Metabolism and nutrition disorders Decreased appetite Very common Very common Common Tumour lysis syndrome† Rare Not known Not known 14 N = 3 834^ N = 243^^ Pertuzumab+trastuzumab Phesgo with chemotherapy Phesgo monotherapy Musculoskeletal and connective tissue disorders Arthralgia Very common Very common Very common Myalgia Very common Very common Common Pain in extremity Very common Common Common Nervous system disorders Dysgeusia Very common Very common Common Headache Very common Very common Common Peripheral sensory neuropathy Very common Very common Common Neuropathy peripheral Very common Very common Common Dizziness Very common Common Common Paraesthesia Very common Common Common Psychiatric disorders Insomnia […]
Based on the pharmacological actions of HER2-targeted agents and anthracyclines, the risk of cardiac toxicity might be expected to be higher with concomitant use of Phesgo and anthracyclines than with sequential use. Sequential use of Phesgo (in combination with a taxane) has been evaluated following the doxorubicin component of two anthracycline-based regimens in the FEDERICA study while sequential use of intravenous pertuzumab (in combination with trastuzumab and a taxane) has been evaluated following the epirubicin or doxorubicin component of many anthracycline-based regimens in the APHINITY and BERENICE studies.
Only limited safety data are available on concurrent use of intravenous pertuzumab in combination with trastuzumab and an anthracycline. 1). Only chemotherapy-naive patients were treated and they received low cumulative doses of epirubicin (up to 300 mg/m2).
In this study, cardiac safety was similar to that observed in patients given the same regimen but with pertuzumab administered sequentially (following FEC chemotherapy). 8). Injection-related reactions were defined as any systemic reaction with symptoms such as fever, chills, headache, likely due to a release of cytokines occurring within 24 hour of administration of Phesgo.
Close observation of the patient during and for 30 minutes after administration of the loading dose and during and for 15 minutes following the administration of the maintenance dose of Phesgo is recommended. If a significant injection-related reaction occurs, the injection should be slowed down or paused and appropriate medical therapies should be administered.
Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be considered in patients with severe injection-related reactions. 2). Although fatal outcomes resulting from injection-related reactions have not been observed with Phesgo, caution should be exercised, as fatal infusion related-reactions have been associated with intravenous pertuzumab in combination with intravenous trastuzumab and chemotherapy.
Hypersensitivity reactions/anaphylaxis Patients should be observed closely for hypersensitivity reactions. 8). The majority of anaphylactic reactions occurred within the first 6-8 cycles of treatment when pertuzumab and trastuzumab were given in combination with chemotherapy.
Medicinal products to treat such reactions, as well as emergency equipment, should be available for immediate use. g. epinephrine, beta-agonists, antihistamines and corticosteroids) should be available for […]