帕妥珠单抗注射剂PERJETA 30MG/ML 14ML SDV

PERJETA Indication and Important Safety InformationINDICATIONPERJETA®(pertuzumab) is a HER2/neu receptor antagonist indicated for:Treatment of metastatic breast cancer in combination with Herceptin® (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 diseaseUse in combination with trastuzumab and docetaxel as 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. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survivalLimitations of Use:The safety of PERJETA as part of a doxorubicin-containing regimen has not been establishedThe safety of PERJETA administered for greater than 6 cycles for early breast cancer has not been establishedImportant Safety InformationBoxed WARNINGS: Cardiomyopathy and Embryo-Fetal ToxicityPERJETA administration can result in subclinical and clinical cardiac failure. eva luate left ventricularfunction in all patients prior to and during treatment with PERJETA. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular functionExposure to PERJETA 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 contraceptionAdditional Important Safety InformationPERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipientsPERJETA has been associated with infusion and hypersensitivity reactions/anaphylaxisDetection of HER2 protein overexpression is necessary for selection of patients appropriate for PERJETA therapyIn the treatment of MBC,the most common adverse reactions (>30%) seen with PERJETA in combination with Herceptin and docetaxel were diarrhea, alopecia, neutropenia, nausea,fatigue, rash, and peripheral neuropathyMost Common Adverse Reactions in Neoadjuvant Treatment of Breast Cancer:The most common adverse reactions(>30%) with PERJETA in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropeniaThe most common adverse reactions(>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea,vomiting, and neutropeniaThe most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia,and anemiaYou may report side effects to the