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Prescribing Information Request a Rep
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Financial Support

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EMPOWER+

Delivering comprehensive resources and services
that support the needs of you and your patients

EMPOWER+ is designed to:

Expand partnership

to further elevate TerSera’s support

Optimize efficiency

by assisting with administrative and process barriers

Enable outcomes

by providing clinical education
to benefit patients

TerSera SupportSource logo

Call 1‑833‑377‑HER2 (4372)
TerSera SupportSource for MARGENZA is available
Monday–Friday 9 AM to 6 PM ET

Co-pay Savings Program

Eligible commercially insured patients may reduce out-of-pocket MARGENZA prescription costs with the MARGENZA Co-pay Savings Program.*

*For eligible patients, the co-pay card is subject to an annual limit. Patients are not eligible if prescriptions are paid for by any state or other federally funded programs. Additional terms and conditions apply.

Download enrollment form

Patient Assistance Program

Being uninsured or underinsured may result in financial barriers and delays in care. TerSera SupportSource is committed to helping eligible patients access the medication they need through our Patient Assistance Program.

The program supports:

  • Eligible uninsured or underinsured patients may receive MARGENZA at no cost through the Patient Assistance Program
  • Coordination with your office to schedule delivery of your patient’s medication to the requested location
Download enrollment form

Billing and coding support

Download the Billing and Coding Guide for more information on how to obtain insurance reimbursement for MARGENZA.

MARGENZA J-CODE: J9353

Download guide

Request a representative

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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.