Active Ingredient: Margetuximab
Margetuximab is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 15 milligrams margetuximab per kilogram of body weight, once every 3 weeks.
The recommended dose of margetuximab is 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
Administer margetuximab as an intravenous infusion at 15 mg/kg over 120 minutes for the initial dose, then over a minimum of 30 minutes every 3 weeks for all subsequent doses.
On days when both margetuximab and chemotherapy are to be administered, margetuximab may be administered immediately after chemotherapy completion.
Refer to the respective Prescribing Information for each therapeutic agent administered in combination with margetuximab for the recommended dosage information, as appropriate.
If a patient misses a dose of margetuximab, administer the scheduled dose as soon as possible. Adjust the administration schedule to maintain a 3-week interval between doses.
Assess left ventricular ejection fraction (LVEF) before starting margetuximab and regularly during treatment. Withhold margetuximab dosing for at least 4 weeks for any of the following:
Margetuximab dosing may be resumed if, within 8 weeks, LVEF returns to normal limits and absolute decrease from baseline is ≤15%. Permanently discontinue margetuximab if LVEF decline persists for greater than 8 weeks, or if dosing is interrupted on greater than 3 occasions for LVEF decline.
Decrease the rate of infusion for mild or moderate infusion-related reactions (IRRs). Interrupt the infusion for dyspnea or clinically significant hypotension. Permanently discontinue margetuximab dosing in patients with severe or life-threatening IRRs.
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