Ogivri Dosage/Direction for Use

Patient Selection: Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [see Indications and Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using tests specific for breast or gastric cancers by laboratories with demonstrated proficiency.
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen 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, can lead to unreliable results.
Recommended Doses and Schedules: Do not administer as an intravenous push or bolus. Do not mix Trastuzumab (Ogivri) with other drugs.
Do not substitute Trastuzumab (Ogivri) 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 Trastuzumab (Ogivri) therapy: During and following paclitaxel, docetaxel, or docetaxel/carboplatin: Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
One week following the last weekly dose of Trastuzumab (Ogivri), administer Trastuzumab (Ogivri) at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.
As a single agent within three weeks following completion of multi-modality, anthracycline based chemotherapy 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 [see as follows].
Extending adjuvant treatment beyond one year is not recommended [see Adverse Reactions].
Metastatic Treatment, Breast Cancer: Administer Trastuzumab (Ogivri), alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.
Metastatic Gastric Cancer: Administer of 2 mg/kg as at an initial dose of 8 mg/kg as a 90 minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks until disease progression [see as follows].
Important Dosing Considerations: If the patient has missed a dose of Trastuzumab (Ogivri) by one week or less, then the usual maintenance dose (weekly schedule: 2 mg/kg; three-weekly schedule: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent Trastuzumab (Ogivri) maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
If the patient has missed a dose of Trastuzumab (Ogivri) by more than one week, a re-loading dose of Trastuzumab (Ogivri) should be administered over approximately 90 minutes(weekly schedule: 4 mg/kg; three-weekly schedule: 8 mg/kg) as soon as possible. Subsequent Trastuzumab (Ogivri) 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 or three-weekly schedules, respectively.
Infusion Reactions: [See Warnings and Precautions.]
Decrease the rate of infusion for mild or moderate infusion reactions.
Interrupt the infusion in patients with dyspnea or clinically significant hypotension.
Discontinue Trastuzumab (Ogivri) for severe or life-threatening infusion reactions.
Cardiomyopathy: [See Warnings and Precautions.]
Assess left ventricular ejection fraction (LVEF) prior to initiation of Trastuzumab (Ogivri) and at regular intervals during treatment. Withhold Trastuzumab (Ogivri) dosing for at least 4 weeks for either of the following: ≥16% absolute decrease in LVEF from pre-treatment values; LVEF below institutional limits of normal and ≥10% absolute decrease in LVEF from pretreatment values.
Trastuzumab (Ogivri) may be resumed if, within 4 to 8 weeks, the LVEF returns to normal limits and the absolute decrease from baseline is ≤15%.
Permanently discontinue Trastuzumab (Ogivri) for a persistent (>8 weeks) LVEF decline or for suspension of Trastuzumab (Ogivri) dosing on more than 3 occasions for cardiomyopathy.