This site is intended for US Healthcare Professionals

Prescribing Information Request a Rep
Margenza logo

Re-engineer HER
immune response

For your pretreated patients with HER2+ metastatic breast cancer (mBC)

MARGENZA is a HER2/neu receptor antagonist 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 illustration only.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends margetuximab-cmkb (MARGENZA) + chemotherapy* as a systemic therapy option in 4L and beyond1

*Capecitabine, eribulin, gemcitabine, or vinorelbine.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

NCCN=National Comprehensive Cancer Network® (NCCN®).

See Guidelines
Icon of MARGENZA

Mechanism of action

See how the engineered Fc region of MARGENZA works

Watch MOA video
Woman in blue scrubs on the phone sitting at a desk lifting a sheet of paper on a clipboard
Actor portrayal.

Financial support

TerSera SupportSource for MARGENZA provides support to help patients access treatment
See support options

Fc=fragment crystallizable; HER2+=human epidermal growth factor receptor 2 positive; MOA=mechanism of action.

Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer. V.3.2026. ©National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 8, 2026. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Indication

MARGENZA is a HER2/neu receptor antagonist 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.

Important Safety Information

BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

  • •

    Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.

  • •

    Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

Additional Important Safety Information

Left Ventricular Dysfunction

  • •

    Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment.

  • •

    In the pivotal SOPHIA trial, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.

  • •

    MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction, or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.

Embryo-Fetal Toxicity

  • •

    Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman.

  • •

    Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.

Infusion-Related Reactions (IRRs)

  • •

    MARGENZA can cause IRRs. Monitor patients during and after MARGENZA infusion for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies.

  • •

    In the pivotal SOPHIA trial, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.

  • •

    Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve.

Most Common Adverse Reactions

The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy in order of frequency are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1‑844‑334‑4035 or medicalinformation@tersera.com.

Please see accompanying Full Prescribing Information, including Boxed Warning.

MARGENZA is a HER2/neu receptor antagonist 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.

BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

  • •

    Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.

  • •

    Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

Additional Important Safety Information

Left Ventricular Dysfunction

  • •

    Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment.

  • •

    In the pivotal SOPHIA trial, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.

  • •

    MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction, or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.

Embryo-Fetal Toxicity

  • •

    Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman.

  • •

    Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.

Infusion-Related Reactions (IRRs)

  • •

    MARGENZA can cause IRRs. Monitor patients during and after MARGENZA infusion for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies.

  • •

    In the pivotal SOPHIA trial, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.

  • •

    Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve.

Most Common Adverse Reactions

The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy in order of frequency are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1‑844‑334‑4035 or medicalinformation@tersera.com.

Please see accompanying Full Prescribing Information, including Boxed Warning.