HER2 testing is mandatory prior to initiation of therapy.
Faceptor treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy and should be administered by a healthcare professional only.
Administration route: intravenous infusion.
DO NOT ADMINISTER AS AN IV PUSH OR BOLUS.
Metastatic breast cancer
Three-weekly schedule
The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Weekly schedule
The recommended initial loading dose of Faceptor is 4 mg/kg body weight. The recommended weekly maintenance dose of Faceptor is 2 mg/kg body weight, beginning one week after the loading dose.
Administration in combination with paclitaxel or docetaxel
In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Administration in combination with an aromatase inhibitor
In the pivotal trial (BO16216), trastuzumab and anastrozole were administered from day 1. There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors).
Early breast cancer
Three-weekly and weekly schedule
As a three-weekly regimen the recommended initial loading dose of Faceptor is 8 mg/kg body weight. The recommended maintenance dose of Faceptor at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.
Metastatic gastric cancer
Three-weekly schedule
The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
