asthistopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2seen in gastric cancers.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents,deviation from specific assay instructions, and failure to include appropriate controls for assay validation, canlead to unreliable results.
2.2 Recommended Doses and Schedules
• Do not administer as an intravenous push or bolus. Do not mix TRAZIMERA with other drugs.
• Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine.
Adjuvant Treatment, Breast Cancer
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERAtherapy:
During and following paclitaxel, docetaxel, or docetaxel and carboplatin:
• Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenousinfusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or
18 weeks (docetaxel and carboplatin).
• One week following the last weekly dose of TRAZIMERA, administer TRAZIMERA at 6 mg/kg as anintravenous infusion over 30 to 90 minutes every three weeks.
As a single agent within three weeks following completion of multi-modality, anthracycline-basedchemotherapy regimens:
• Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes.
• Subsequent doses at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks [seeDosage and Administration (2.3)].
• Extending adjuvant treatment beyond one year is not recommended [see Adverse Reactions (6.1)].
Metastatic Treatment, Breast Cancer
• Administer TRAZIMERA, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minuteintravenous infusions until disease progression.
Metastatic Gastric Cancer
• Administer TRAZIMERA at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed bysubsequent doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks untildisease progression [see Dosage and Administration (2.3)].
2.3 Important Dosing Considerations
If the patient has missed a dose of TRAZIMERA by one week or less, then the usual maintenance dose (weeklyschedule: 2 mg/kg; three-weekly schedule: 6 mg/kg) should be administered as soon as possible. Do not waituntil the next planned cycle. Subsequent TRAZIMERA maintenance doses should be administered 7 days or21 days later according to the weekly or three-weekly schedules, respectively.
If the patient has missed a dose of TRAZIMERA by more than one week, a re-loading dose of TRAZIMERAshould be administered over approximately 90 minutes (weekly schedule: 4 mg/kg; three-weekly schedule:8 mg/kg) as soon as possible. Subsequent TRAZIMERA maintenance doses (weekly schedule: 2 mg/kg;three-weekly schedule 6 mg/kg) should be administered 7 days or 21 days later according to the weekly orthree-weekly schedules, respectively.
Infusion Reactions
[See Boxed Warning, Warnings and Precautions (5.2)]
• Decrease the rate of infusion for mild or moderate infusion reactions
• Interrupt the infusion in patients with dyspnea or clinically significant hypotension
• Discontinue TRAZIMERA for severe or life-threat |
