Page 15 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph
P. 15

7. RECOMMENDED DOSING AND ADMINISTRATION FOR

               FIXED-DOSE SC COMBINATION OF TRASTUZUMAB AND PER-

               TUZUMAB



               7.1. Dosing and administration for fixed-dose SC combination of
               trastuzumab and pertuzumab



               Fixed-dose SC combination of trastuzumab and pertuzumab has different dosage
               and administration instructions than IV pertuzumab, IV trastuzumab, and SC

               trastuzumab when administered alone. Do not substitute fixed-dose SC
               combination of trastuzumab and pertuzumab for or with PERJETA , trastuzumab,
                                                                                        ®
               ado-trastuzumab emtansine (KADCYLA ), or fam-trastuzumab deruxtecan.              39
                                                           ®


               Fixed-dose SC combination of trastuzumab and pertuzumab should be
               administered every 3 weeks        39


               Loading (initial) dose       1200 mg pertuzumab, 600 mg trastuzumab, 30,000 units

                                            hyaluronidase per 15 mL supplied in a single-dose,
                                            ready-to-use vial
                                            Administer subcutaneously over approximately 8 minutes
                        15 mL
                                            Observe for hypersensitivity or administration-related
                                            reactions: minimum of 30 minutes*



               Maintenance dose             600 mg pertuzumab, 600 mg trastuzumab, 20,000 units
                                            hyaluronidase per 10 mL supplied in a single-dose,
                                            ready-to-use vial
                                            Administer subcutaneously over approximately 5 minutes
                      10 mL
                                            Observe for hypersensitivity or administration-related
                                             reactions: minimum of 15 minutes*



               *Medications to treat such reactions, as well as emergency equipment, should be available for immediate use.


               Administration instructions      39
               Fixed-dose SC combination of trastuzumab and pertuzumab must always be
               administered by a healthcare professional. Fixed-dose SC combination of

               trastuzumab and pertuzumab is for SC use ONLY in the thigh.
               Do NOT administer intravenously.
                Do not split the dose between 2 syringes or between 2 sites of administration.

                Injection site should be alternated between the left and right thigh only.



           M-AE-00000086                                                                                 15
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