MARGENZA (margetuximab-cmkb) resources for your practice

Take advantage of these helpful MARGENZA communication tools

Resources

MARGENZA Prescribing Information

Download the full Prescribing Information, including Boxed Warning for MARGENZA.

Download

Download the Co-pay Assistance Enrollment Form and Patient Assistance Program Enrollment Form at MARGENZA Access Support.

Go to Access Support Site

Billing and Coding Guide

Download for more information on how to obtain insurance reimbursement for MARGENZA.

Download

MARGENZA Patient Brochure

Download for information that can help patients and caregivers better understand what to expect from MARGENZA, including treatment benefits, how it works, how it’s given, and more.

Download

Fact Sheet

Download for National Drug Codes and additional quick reference information.

Download

View efficacy and safety results
in the SOPHIA publication

See Publication

Product Distribution Information

Authorized Distributor

TerSera does not recommend the use of one authorized distributor over another. TerSera does not make any warranty as to the services offered by any particular authorized distributor.

MARGENZA Access Support is here to help
your patients with affordability issues

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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 study, 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 study, 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.

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.

Please see accompanying Full Prescribing Information, including BOXED WARNING.

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 study, 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 study, 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:

Please see accompanying Full Prescribing Information, including BOXED WARNING.

INDICATION

Please see accompanying Full Prescribing Information, including BOXED WARNING.

MARGENZA (margetuximab-cmkb) resources for your practice

Take advantage of these helpful MARGENZA communication tools

Resources

MARGENZA Prescribing Information

Billing and Coding Guide

MARGENZA Patient Brochure

Fact Sheet

Product Distribution Information

ASD Healthcare

Cardinal Health Specialty Distribution

McKesson Plasma and Biologics

McKesson Specialty Care Distribution

Oncology Supply

Be in the know

Register for the latest information and updates about MARGENZA

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