All Names: Pertuzumab,Perjeta
Indications:1. Metastatic Breast Cancer (MBC); 2. Early Breast Cancer (EBC)
Manufacturer:Roche, Switzerland
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INDICATIONS AND USAGE(适应症)
Metastatic Breast Cancer (MBC)
PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Early Breast Cancer (EBC)
PERJETA is indicated for use in combination with trastuzumab and chemotherapy for:
the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
DOSAGE(服用剂量)
The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.
When administered with PERJETA, the recommended initial dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes.
When administered with PERJETA, the recommended initial dose of trastuzumab hyaluronidase-oysk is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2 to 5 minutes once every three weeks irrespective of the patient's body weight.
PERJETA, trastuzumab or trastuzumab hyaluronidase-oysk, and taxane should be administered sequentially. PERJETA and trastuzumab or trastuzumab hyaluronidase-oysk can be given in any order. Taxane should be administered after PERJETA and trastuzumab or trastuzumab hyaluronidase-oysk. An observation period of 30 to 60 minutes is recommended after each PERJETA infusion and before commencement of any subsequent administration of trastuzumab or trastuzumab hyaluronidase-oysk, or taxane.
In patients receiving an anthracycline-based regimen, PERJETA and trastuzumab or trastuzumab hyaluronidase-oysk should be administered following completion of the anthracycline.
Metastatic Breast Cancer (MBC)
When administered with PERJETA, the recommended initial dose of docetaxel is 75 mg/m2 administered as an intravenous infusion. The dose may be escalated to 100 mg/m2 administered every 3 weeks if the initial dose is well tolerated.
Neoadjuvant Treatment of Breast Cancer
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 or trastuzumab hyaluronidase-oysk and docetaxel followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) as given in NeoSphere
Three or four preoperative cycles of FEC alone followed by 3 or 4 preoperative cycles of PERJETA in combination with docetaxel and trastuzumab or trastuzumab hyaluronidase-oysk as given in TRYPHAENA and BERENICE, respectively
Six preoperative cycles of PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) or trastuzumab hyaluronidase-oysk (escalation of docetaxel above 75 mg/m2 is not recommended) as given in TRYPHAENA
Four preoperative cycles of dose-dense doxorubicin and cyclophosphamide (ddAC) alone followed by 4 preoperative cycles of PERJETA in combination with paclitaxel and trastuzumab or trastuzumab hyaluronidase-oysk as given in BERENICE
Following surgery, patients should continue to receive PERJETA and trastuzumab or trastuzumab hyaluronidase-oysk to complete 1 year of treatment (up to 18 cycles).
Adjuvant Treatment of Breast Cancer
PERJETA should be administered in combination with trastuzumab or trastuzumab hyaluronidase-oysk every 3 weeks for a total of 1 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, including standard anthracycline- and/or taxane-based chemotherapy as given in APHINITY. PERJETA and trastuzumab or trastuzumab hyaluronidase-oysk should start on Day 1 of the first taxane-containing cycle.
ADVERSE REACTIONS(不良反应)
Left Ventricular Dysfunction
Embryo-Fetal Toxicity
Infusion-Related Reactions
Hypersensitivity Reactions/Anaphylaxis
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/17f85d17-ab71-4f5b-9fe3-0b8c822f69ff/spl-doc?hl=Pertuzumab
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