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PERJETA is a brand name for Pertuzumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Early Breast Cancer PERJETA (pertuzumab for injection) in combination with trastuzumab and chemotherapy is indicated for the: • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive) (see 14 Clinical Trials…
Verbatim from this product's HC label. Tap a section to expand.
0 by ISH assessed by a validated test. To ensure accurate and reproducible results, the testing must be performed in a laboratory which can ensure validation of the testing procedures. For full instructions on assay performance and interpretation, please refer to the package inserts of validated HER2 testing assays.
2 Recommended Dose and Dosage Adjustment Recommended Dose: Metastatic and Early Breast Cancer The recommended initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420 mg administered over a period of 30 to 60 minutes.
An observation period of 30 to 60 minutes is recommended after completion of each PERJETA infusion. The observation period should be completed prior to any subsequent dose PrPERJETA® (pertuzumab for injection) Page 6 of 72 of trastuzumab or chemotherapy (see 7 WARNINGS AND PRECAUTIONS: Infusion-related reactions and WARNINGS AND PRECAUTIONS: Hypersensitivity reactions/anaphylaxis).
PERJETA and trastuzumab should be administered sequentially and can be given in any order. When administered with PERJETA, the recommendation is to follow a 3-weekly schedule for trastuzumab administered as either: • a trastuzumab intravenous infusion with an initial loading dose of 8 mg/kg followed every 3 weeks thereafter by a dose of 6 mg/kg body weight.
or • a fixed dose of trastuzumab subcutaneous injection (600mg) for the initial dose and every 3 weeks thereafter irrespective of the patient’s body weight. In patients receiving a taxane, PERJETA and trastuzumab should be administered prior to the taxane.
When administered with PERJETA, the recommended initial dose of docetaxel is 75 mg/m2. If a carboplatin-based regimen is used, the recommended dose for docetaxel is 75 mg/m2 throughout (no dose escalation). In patients receiving an anthracycline-based regimen, PERJETA and trastuzumab should be administered following completion of the anthracycline treatment.
Neoadjuvant treatment of Early Breast Cancer In the neoadjuvant setting (before surgery), it is recommended that patients are treated with PERJETA for three to six cycles depending on the regimen chosen in combination with trastuzumab and chemotherapy.
PERJETA should be administered every 3 weeks for 3 to 6 cycles as part of one of the following treatment regimens for early breast cancer: • Four preoperative cycles of PERJETA in combination with trastuzumab and docetaxel (75 mg/m2 with the option to escalate to 100 mg/m2 at physician discretion if initial dose is well tolerated), every 3 weeks, followed by 3 postoperative cycles of 5-fluorouracil (600 mg/m2), epirubicin (90 mg/m2), and cyclophosphamide (600 mg/m2) (FEC), every 3 weeks, as given in NeoSphere • Three or four preoperative cycles of FEC (F: 500 mg/m2; E: 100 mg/m2; C: 600 mg/m2) alone, every 3 weeks, followed by 3 or 4 preoperative cycles of PERJETA in combination with docetaxel (75 mg/m2 with the option to escalate to 100 mg/m2 at physician discretion if initial dose is well tolerated) and trastuzumab, every 3 weeks, as given in TRYPHAENA and BERENICE, respectively • Six preoperative cycles of PERJETA in combination with docetaxel (75 mg/m2: escalation of docetaxel above 75 mg/m2 is not recommended), carboplatin (AUC 6), and trastuzumab (TCH), every 3 weeks, as given in TRYPHAENA • Four preoperative cycles of dose-dense doxorubicin and cyclophosphamide (ddAC; A: 60 mg/m2; C: 600 mg/m2) alone, every 2 weeks, followed by 4 preoperative cycles of PERJETA in combination with trastuzumab, every 3 weeks, and paclitaxel (80 mg/m2) every week for 12 weeks, as given in BERENICE PrPERJETA® (pertuzumab for injection) Page 7 of 72 Patients who start PERJETA and trastuzumab in the neoadjuvant setting may at the discretion of the physician continue to receive adjuvant PERJETA and trastuzumab to complete 1 year of treatment (maximum 18 cycles).
). PERJETA has not been studied in patients with: a pre-treatment LVEF value of ≤ 50%; a prior history of congestive heart failure (CHF); decreases in LVEF to <50% during prior trastuzumab adjuvant therapy; 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 > 360mg/m2 of doxorubicin or its equivalent.
Prior to the initiation of PERJETA and trastuzumab, candidate patients should undergo thorough baseline cardiac assessment including history and physical exam, electrocardiogram (ECG) and either 2D echocardiogram or multiple gated acquisition (MUGA) scan to ensure that LVEF is within normal limits.
A careful risk-benefit assessment should be made before deciding to treat with PERJETA and trastuzumab. Cardiac assessments, as performed at baseline, should be repeated at regular intervals (see Table 3 below). If the LVEF declines as indicated in Table 3 and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Following discontinuation of treatment, cardiac assessments should be performed every 6 months up until 24 months from the last administration of PERJETA and/or trastuzumab. PrPERJETA® (pertuzumab for injection) Page 12 of 72 Table 3 Dose Recommendations for Left Ventricular Dysfunction Pre- treatment LVEF: Monitor LVEF every: Withhold PERJETA and trastuzumab for at least 3 weeks for an LVEF decrease to: Resume PERJETA and trastuzumab after 3 weeks if LVEF has recovered to: Metastatic Breast Cancer ≥ 50% ~12 weeks Either Either <40% 40%-45% with a fall of ≥10%- points below pre- treatment value >45% 40%-45% with a fall of <10%-points below pre- treatment value Early Breast Cancer ≥ 55%* ~12 weeks (once during neoadjuvant therapy) <50% with a fall of ≥10%-points below pre-treatment value Either ≥ 50% < 10% points below pre- treatment value *for patients receiving anthracycline-based chemotherapy, a LVEF of ≥ 50% is required after completion of anthracyclines, before starting PERJETA and trastuzumab Driving and Operating Machinery Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
Cardiovascular, Left Ventricular Dysfunction.
Embryo-Fetal Toxicity:
Exposure to PERJETA (pertuzumab) can result in embryo-fetal death and birth defects. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Advise patients of these risks and the need for effective contraception (see 7 WARNINGS AND PRECAUTION: Special Population, Pregnant Women).
Hypersensitivity reactions /anaphylaxis and Infusion-related reactions:
PERJETA has been associated with severe hypersensitivity reactions, anaphylaxis and infusion-related reactions.
Events with fatal outcomes have been observed (see 7 WARNINGS AND PRECAUTION:
Immune). Patients should be evaluated and carefully monitored during and after infusions. Permanent discontinuation should be considered in patients with severe reactions. 0 by ISH assessed by a validated test. To ensure accurate and reproducible results, the testing must be performed in a laboratory which can ensure validation of the testing procedures.
For full instructions on assay performance and interpretation, please refer to the package inserts of validated HER2 testing assays. 2 Recommended Dose and Dosage Adjustment Recommended Dose: Metastatic and Early Breast Cancer The recommended initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420 mg administered over a period of 30 to 60 minutes.
An observation period of 30 to 60 minutes is recommended after completion of each PERJETA infusion. The observation period should be completed prior to any subsequent dose PrPERJETA® (pertuzumab for injection) Page 6 of 72 of trastuzumab or chemotherapy (see 7 WARNINGS AND PRECAUTIONS: Infusion-related reactions and WARNINGS AND PRECAUTIONS: Hypersensitivity reactions/anaphylaxis).
PERJETA (pertuzumab) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see the Dosage Forms, Strengths, Composition and Packaging section of the product monograph.
• Refer to the Product Monographs of trastuzumab and docetaxel for further information on the contraindications of these drugs. PrPERJETA® (pertuzumab for injection) Page 5 of 72
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Adjuvant treatment of Early Breast Cancer In the adjuvant setting (after surgery), PERJETA should be administered in combination with trastuzumab for a total of one year (maximum 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first), as part of a complete regimen for early breast cancer, including standard anthracycline- and/or taxane-based chemotherapy.
PERJETA and trastuzumab should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued (see 14 CLINICAL TRIALS). Metastatic Breast Cancer PERJETA should be administered in combination with trastuzumab and docetaxel until disease progression or unmanageable toxicity.
Treatment with PERJETA and trastuzumab may continue even if treatment with docetaxel is discontinued. In the pivotal clinical trial CLEOPATRA, for the loading dose of PERJETA in Cycle 1, it was administered on the first day; trastuzumab (intravenous formulation) was administered on the following day and followed by docetaxel on the same day.
If all three medications could be tolerated in Cycle 1, in the subsequent cycles they could be administered in the same sequence on the same day.
Dose Adjustments:
Dose reductions are not recommended for PERJETA and trastuzumab (see the trastuzumab (intravenous formulation) and trastuzumab (subcutaneous formulation) Product Monographs). For chemotherapy dose modifications, see relevant Product Monograph.
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 dose modifications, see the Product Monograph for docetaxel.
A reduction in docetaxel dose was required in approximately 25% of patients in both treatment arms in the pivotal trial CLEOPATRA.
Infusion-related reactions:
The infusion rate of PERJETA may be slowed or the […]
Gastrointestinal Diarrhea PERJETA may elicit severe diarrhea (see 8 ADVERSE REACTIONS). In case of onset of severe diarrhea an anti-diarrheal treatment should be instituted and interruption of the treatment with PERJETA should be considered if no improvement of the condition is achieved.
When the diarrhea is under control the treatment with PERJETA may be reinstated. Hematologic Febrile Neutropenia Patients treated with PERJETA, trastuzumab and docetaxel are at increased risk of febrile neutropenia compared with patients treated with placebo, trastuzumab and docetaxel, especially during the first 3 cycles of treatment (see 8 ADVERSE REACTIONS).
As nadir neutrophil counts were similar in PERJETA-treated and placebo-treated patients, the higher incidence of febrile neutropenia in PERJETA-treated patients may be related to the higher incidence of mucositis and diarrhea in these patients.
Symptomatic treatment for mucositis and diarrhea should be considered. Hepatic/Biliary/Pancreatic The safety and efficacy of PERJETA have not been studied in patients with hepatic impairment. PrPERJETA® (pertuzumab for injection) Page 13 of 72 Immune Hypersensitivity reactions/anaphylaxis Patients should be observed closely for hypersensitivity reactions.
Severe hypersensitivity reactions, including anaphylaxis and events with fatal outcomes, have been observed in patients treated with PERJETA (see 8 ADVERSE REACTIONS). Medications to treat such reactions, as well as emergency equipment, should be available for immediate use.
PERJETA must be permanently discontinued in case of NCI-CTCAE Grade 4 hypersensitivity reactions (anaphylaxis), bronchospasm or acute respiratory distress syndrome (ARDS). PERJETA is contraindicated in patients who are hypersensitive to pertuzumab or to any ingredient in the formulation (see 2 CONTRAINDICATIONS).
Infusion-related reactions PERJETA has been associated with infusion-related reactions, including events with fatal outcomes (see 8 ADVERSE REACTIONS). Close observation of the patient during and for 60 minutes after the first infusion and during and for 30 minutes following subsequent infusions of PERJETA is recommended.
If a significant infusion-related reaction occurs, the infusion should be slowed down or interrupted 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 infusion reactions. This clinical assessment should be based on the severity of the preceding reaction and response to administered treatment for the adverse reaction (see 4 DOSAGE AND ADMINISTRATION).
Race In the pivotal trial WO20698/TOC4129g (CLEOPATRA), an increased incidence of neutropenia and febrile neutropenia was observed for Asian patients in both treatment arms compared with patients of other races and from other geographic regions.
6%). 3%). 9% in the placebo-treated group. The reason for this difference is not known. In the MetaPHER study, the Asian population, comprised of only two patients, was too small for any meaningful conclusion and for comparison with the […]
PERJETA and trastuzumab should be administered sequentially and can be given in any order. When administered with PERJETA, the recommendation is to follow a 3-weekly schedule for trastuzumab administered as either: • a trastuzumab intravenous infusion with an initial loading dose of 8 mg/kg followed every 3 weeks thereafter by a dose of 6 mg/kg body weight.
or • a fixed dose of trastuzumab subcutaneous injection (600mg) for the initial dose and every 3 weeks thereafter irrespective of the patient’s body weight. In patients receiving a taxane, PERJETA and trastuzumab should be administered prior to the taxane.
When administered with PERJETA, the recommended initial dose of docetaxel is 75 mg/m2. If a carboplatin-based regimen is used, the recommended dose for docetaxel is 75 mg/m2 throughout (no dose escalation). In patients receiving an anthracycline-based regimen, PERJETA and trastuzumab should be administered following completion of the anthracycline treatment.
Neoadjuvant treatment of Early Breast Cancer In the neoadjuvant setting (before surgery), it is recommended that patients are treated with PERJETA for three to six cycles depending on the regimen chosen in combination with trastuzumab and chemotherapy.
PERJETA should be administered every 3 weeks for 3 to 6 cycles as part of one of the following treatment regimens for early breast cancer: • Four preoperative cycles of PERJETA in combination with trastuzumab and docetaxel (75 mg/m2 with the option to escalate to 100 mg/m2 at physician discretion if initial dose is well tolerated), every 3 weeks, followed by 3 postoperative cycles of 5-fluorouracil (600 mg/m2), epirubicin (90 mg/m2), and cyclophosphamide (600 mg/m2) (FEC), every 3 weeks, as given in NeoSphere • Three or four preoperative cycles of FEC (F: 500 mg/m2; E: 100 mg/m2; C: 600 mg/m2) alone, every 3 weeks, followed by 3 or 4 preoperative cycles of PERJETA in combination with docetaxel (75 mg/m2 with the option to escalate to 100 mg/m2 at physician discretion if initial dose is well tolerated) and trastuzumab, every 3 weeks, as given in TRYPHAENA and BERENICE, respectively • Six preoperative cycles of PERJETA in combination with docetaxel (75 mg/m2: escalation of docetaxel above 75 mg/m2 is not recommended), carboplatin (AUC 6), and trastuzumab (TCH), every 3 weeks, as given in TRYPHAENA • Four preoperative cycles of dose-dense doxorubicin and cyclophosphamide (ddAC; A: 60 mg/m2; C: 600 mg/m2) alone, every 2 weeks, followed by 4 preoperative cycles of PERJETA in combination with trastuzumab, every 3 weeks, and paclitaxel (80 mg/m2) every week for 12 weeks, as given in BERENICE PrPERJETA® (pertuzumab for injection) Page 7 of 72 Patients who start PERJETA and trastuzumab in the neoadjuvant setting may at the discretion of the physician continue to receive adjuvant PERJETA and trastuzumab to complete 1 year of treatment (maximum 18 cycles).
Adjuvant treatment of Early Breast Cancer In the adjuvant setting (after surgery), PERJETA should be administered in combination with trastuzumab for a total of one year (maximum 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first), as part of a complete regimen for early breast cancer, including standard anthracycline- and/or taxane-based chemotherapy.
PERJETA and trastuzumab should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued (see 14 CLINICAL TRIALS). Metastatic Breast Cancer PERJETA should be administered in combination with trastuzumab and docetaxel until disease progression or unmanageable toxicity.
Treatment with PERJETA and trastuzumab may continue even if treatment with docetaxel is discontinued. In the pivotal clinical trial CLEOPATRA, for the loading dose of PERJETA in Cycle 1, it was administered on the first day; trastuzumab (intravenous formulation) was administered on the following day and followed by docetaxel on the same day.
If all three medications could be […]