Breastcancer.org
The mission of Breastcancer.org is to help people make sense of the complex medical information about breast health and breast cancer, so they can make the best decisions for their lives.
This site is intended for US Healthcare Professionals
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Download for more information that can help patients and caregivers better understand what to expect from MARGENZA, including treatment benefits, how it works, how it’s administered, and more.
Includes enrollment and insurance verification sections for eligible, commercially insured patients who would like to apply for the Co-pay Savings Program to offset their cost share for MARGENZA. Also includes prescriber enrollment instructions.
Includes enrollment and eligibility verification sections for patients who have been prescribed MARGENZA and would like to apply to receive the medication free of charge if they qualify. Also includes prescriber enrollment instructions.
Find an organization that can help support your patients with HER2+ mBC, their loved ones, and their caregivers.
The mission of Breastcancer.org is to help people make sense of the complex medical information about breast health and breast cancer, so they can make the best decisions for their lives.
Unite for HER’s mission is to enrich the health and well-being of those diagnosed with breast and ovarian cancer—for life, by funding and delivering integrative therapies.
Young Survival Coalition (YSC) is an international nonprofit dedicated exclusively to young adults diagnosed with breast cancer age 40 and under and their co-survivor support networks. Through educational resources and programming, annual conferences, and local and online support networks, YSC ensures no young adult faces breast cancer alone.
Touch, The Black Breast Cancer Alliance drives the collaborative efforts of patients, survivors, advocates, advocacy organizations, healthcare professionals, researchers, and pharmaceutical companies to work collectively, with accountability, toward the common goal of eradicating Black Breast Cancer.
Living Beyond Breast Cancer is a national nonprofit organization that seeks to create a world that understands there is more than one way to have breast cancer. To fulfill its mission of providing trusted information and a community of support to those impacted by the disease, Living Beyond Breast Cancer offers live programs and on-demand emotional, practical, and evidence-based content.
Over 30 years since its inception, the organization remains committed to creating a culture of acceptance—where sharing the diversity of the lived experience of breast cancer fosters self-advocacy and hope. For more information, visit online or call (855) 807‑6386.
These organizations are independent and not owned or controlled by TerSera, which makes no representations about the services and information they may offer. Their inclusion on this website is not intended as an endorsement of the organization or the services offered, nor is it an indication of the organization’s endorsement of MARGENZA.
HER2+=human epidermal growth factor receptor 2 positive.
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Download resourcesIndication
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.
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.
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.
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