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