Page 18 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

Monitor LVEF prior to initiation and then every ~12 weeks in mBC and eBC
(once during neoadjuvant therapy).

If after a repeat assessment within approximately 3 weeks, the LVEF has not improved, has declined further, and/or the patient is symptomatic,
permanently discontinue fixed-dose SC combination of trastuzumab and pertuzumab.

7.3. Preparation and storage

Vial storage 39
Fixed-dose SC combination of trastuzumab and pertuzumab is supplied in sterile,
preservative-free, single-dose vials for SC administration. Store fixed-dose SC

combination of trastuzumab and pertuzumab vials in the refrigerator at 2°C to
8°C (36°F to 46°F) in the original carton to protect from light, until time of use. Do
not freeze.

Checking the vial 39
 To prevent medication errors, it is important to check the vial labels to ensure
that the drug being prepared and administered is fixed-dose SC combination

of trastuzumab and pertuzumab and not IV PERJETA , or IV or SC trastuzumab.
®
 Inspect the vial for particulate matter and discoloration prior to administration,
whenever solution and container permit. Do not use vial if particulates or

discoloration is present. The solution should be clear to opalescent, colorless to
slightly brownish. Do not shake.

Preparing the injection 39

 A syringe, a transfer needle, and an injection needle are needed to withdraw
fixed-dose SC combination of trastuzumab and pertuzumab solution from the
vial and inject it subcutaneously. Fixed-dose SC combination of trastuzumab

and pertuzumab is compatible with stainless steel, polypropylene,
polycarbonate, polyethylene, polyurethane, polyvinyl chloride, and fluorinated
ethylene polypropylene.

 Do not dilute fixed-dose SC combination of trastuzumab and pertuzumab. Use
a syringe with a transfer needle to withdraw the fixed-dose SC combination of

trastuzumab and pertuzumab solution from the vial. Discard any unused
portion remaining in the vial. Remove transfer needle.
 Immediately prior to administration, attach a 25G-27G (3/8”–5/8”) hypodermic
injection needle to the syringe. Check the syringe to ensure the right dose is

being administered: initial dose (15 mL) or maintenance dose (10 mL).
 Inject fixed-dose SC combination of trastuzumab and pertuzumab into

patient’s thigh slowly and gently over about 8 minutes for the initial dose and
about 5 minutes for the maintenance dose.

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