PERJETA IS INDICATED FOR USE IN COMBINATION WITH TRASTUZUMAB AND DOCETAXEL 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 INITIAL DOSE 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 PERTUZUMAB, 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. PERTUZUMAB, TRASTUZUMAB, AND DOCETAXEL SHOULD BE ADMINISTERED SEQUENTIALLY. PERTUZUMAB AND TRASTUZUMAB CAN BE GIVEN IN ANY ORDER. DOCETAXEL SHOULD BE ADMINISTERED AFTER PERTUZUMAB AND TRASTUZUMAB. AN OBSERVATION PERIOD OF 30 TO 60 MINUTES IS RECOMMENDED AFTER EACH PERTUZUMAB INFUSION AND BEFORE COMMENCEMENT OF ANY SUBSEQUENT INFUSION OF TRASTUZUMAB OR DOCETAXEL.
METASTATIC BREAST CANCER (MBC)
WHEN ADMINISTERED WITH PERTUZUMAB, THE RECOMMENDED INITIAL DOSE OF DOCETAXEL IS 75 MG/MΒ² ADMINISTERED AS AN INTRAVENOUS INFUSION. THE DOSE MAY BE ESCALATED TO 100 MG/M ADMINISTERED EVERY 3 WEEKS IF THE INITIAL DOSE IS WELL TOLERATED.
NEOADJUVANT TREATMENT OF BREAST CANCER
PERTUZUMAB 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 PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND DOCETAXEL FOLLOWED BY 3 POSTOPERATIVE CYCLES OF FLUOROURACIL, EPIRUBICIN, AND CYCLOPHOSPHAMIDE (FEC)
" THREE PREOPERATIVE CYCLES OF FEC ALONE FOLLOWED BY 3 PREOPERATIVE CYCLES OF PERTUZUMAB IN COMBINATION WITH DOCETAXEL AND TRASTUZUMAB
" SIX PREOPERATIVE CYCLES OF PERTUZUMAB IN COMBINATION WITH DOCETAXEL, CARBOPLATIN, AND TRASTUZUMAB (TCH) (ESCALATION OF DOCETAXEL ABOVE 75 MG/MΒ² IS NOT RECOMMENDED)
FOLLOWING SURGERY, PATIENTS SHOULD CONTINUE TO RECEIVE TRASTUZUMAB TO COMPLETE 1 YEAR OF TREATMENT. THERE IS INSUFFICIENT EVIDENCE TO RECOMMEND CONTINUED USE OF PERTUZUMAB FOR GREATER THAN 6 CYCLES FOR EARLY BREAST CANCER. THERE IS INSUFFICIENT EVIDENCE TO RECOMMEND CONCOMITANT ADMINISTRATION OF AN ANTHRACYCLINE WITH PERTUZUMAB, AND THERE ARE NO SAFETY DATA TO SUPPORT SEQUENTIAL USE OF DOXORUBICIN WITH PERTUZUMAB.
FOR DOSE MODIFICATION IN VARIOUIS CONDITIONS , PLEASE CONSULT MONOGRAPH.