Page 17 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph
P. 17

Delayed or missed doses of fixed-dose SC combination of trastuzumab
               and pertuzumab       39


                If the time between                      Do not wait until the next planned dose
                2 sequential injections is               Administer the maintenance dose of
                <6 weeks                                 600 mg, 600 mg, 20,000 units/10 mL


                If the time between                      Re administer the initial dose of 1,200 mg,
                2 sequential injections is               600 mg, 30,000 units/15 mL followed every
                ≥6 weeks                                 3 weeks thereafter by maintenance dose of
                                                         600 mg, 600 mg, 20,000 units/10 mL



               Dosing adjustments       39
                No dose adjustments for fixed-dose SC combination of trastuzumab and
                    pertuzumab are required for patient body weight or for concomitant

                    chemotherapy regimen.
                For chemotherapy dose modification, see relevant prescribing information.
                If patient experiences a significant injection-related reaction, slow down or

                    pause the injection, do not move the needle out of the injection site and
                    administer appropriate medical therapies. Evaluate and carefully monitor
                    patients until complete resolution of signs and symptoms.

                If patient experiences a serious hypersensitivity reaction (e.g., anaphylaxis),
                   discontinue injection immediately.



               Dose modification and monitoring for left ventricular dysfunction               39
               Assess left ventricular ejection fraction (LVEF) prior to initiation of  fixed-dose SC

               combination of trastuzumab and pertuzumab and at regular intervals during treatment.


                                                Withhold fixed-dose               Resume fixed-dose
                                                 SC combination of               SC combination of
                  Pre-treatment LVEF:      trastuzumab and pertuzumab for    trastuzumab and pertuzumab
                                             at least 3 weeks for an LVEF      after 3 weeks if LVEF has
                                                   decrease to:                    recovered to:
                                                                                      Either
                                            <50% with a fall of ≥10%-points
                 eBC           ≥ 55%*         below pre-treatment value     ≥50%      <10% points below
                                                                                     pre-treatment value


                                                                                      Either

                 mBC           ≥ 50%       <40%       40%-45% with a fall  >45%      40%-45% with a fall
                                                     of ≥10%-points below           of <10%-points below
                                                     pre-treatment value             pre-treatment value



               * For patients receiving anthracycline-based chemotherapy, an LVEF of ≥50% is required after completion of anthracyclines before starting fixed-dose
               subcutaneous combination of trastuzumab and pertuzumab.


           M-AE-00000086                                                                                 17
   12   13   14   15   16   17   18   19   20   21   22