Page 19 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph
P. 19

Syringe storage    39
                If the syringe containing fixed-dose SC combination of trastuzumab and
                pertuzumab is not used immediately, it can be stored in the refrigerator for up to

                24 hours (2°C to 8°C, 36°F to 46°F) and at room temperature for up to 4 hours
                (20°C to 25°C, 68°F to 77°F). Avoid unnecessary storage.



                 If the dose is not to be administered immediately, and the solution of fixed-dose
                     SC combination of trastuzumab and pertuzumab has been withdrawn from

                     the vial into the syringe, replace the transfer needle with a syringe closing cap.
                 Do not attach a hypodermic needle until time of administration to avoid needle
                     clogging.

                 Label the syringe with the peel-off sticker.


                7.4. Treatment regimens for eBC and mBC, based on pertuzumab studies and

                       FeDeriCa


                eBC treatment regimen        35,39

                Eligible patients with HER2+ eBC should receive fixed-dose SC combination of
                trastuzumab and pertuzumab every 3 weeks to complete 1 year of treatment (up

                to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever
                occurs first, as part of a complete treatment regimen including anthracycline-
                and/or taxane-based chemotherapy.



                Neoadjuvant chemotherapy regimens


                Neoadjuvant Setting                            Adjuvant Setting

                4 cycles of fixed-dose SC combination of         3 postoperative cycles of FEC† and continue fixed-
                trastuzumab and pertuzumab + docetaxel*         dose SC combination of trastuzumab and
                (based on pertuzumab studies)                   pertuzumab to complete 1 year (up to 18 cycles) of
                                                                treatment per full Prescribing Information

                3 or 4 cycles of FEC,  followed by 3 or 4 cycles of
                                †
                fixed-dose SC combination of trastuzumab and
                pertuzumab + docetaxel  (based on pertuzumab   S
                                   *
                studies)                                     U
                                                             R
                6 cycles of fixed-dose SC combination of         Continue fixed-dose SC combination of
                trastuzumab and pertuzumab + docetaxel  +    G  trastuzumab and pertuzumab to complete 1 year
                                                 *
                carboplatin  (based on pertuzumab studies)   E  (up to 18 cycles) of treatment per full Prescribing
                         ‡
                                                             R  Information
                             §
                4 cycles of ddAC,  followed by 4 cycles of fixed-dose   Y
                SC combination of trastuzumab and pertuzumab +
                paclitaxel  or docetaxel  (based on a pertuzumab
                                  *
                       ||
                study and FeDeriCa)
                4 cycles of AC,  followed by 4 cycles of fixed-dose SC
                           ¶
                combination of trastuzumab and pertuzumab +
                docetaxel  (based on FeDeriCa)
                       *
           M-AE-00000086                                                                                 19
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