Dosing and administration
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Dosing informationSafety Profile
For illustration only.
In the SOPHIA trial, MARGENZA had a comparable safety profile to trastuzumab1,2
Adverse reactions (>10%) in patients with HER2+ metastatic breast cancer (mBC) who received MARGENZA1
*Includes headache and migraine.
†Includes abdominal pain, abdominal discomfort, lower abdominal pain, and upper abdominal pain.
‡Includes peripheral neuropathy, peripheral sensory neuropathy, peripheral motor neuropathy, and neuropathy.
Serious adverse reactions occurred in 16% of patients who received MARGENZA + chemotherapy1
- Serious adverse reactions in >1% of patients included febrile neutropenia (1.5%), neutropenia/neutrophil count decrease (1.5%), and infusion-related reactions (IRRs) (1.1%)
- Fatal adverse reactions occurred in 1.1% of patients who received MARGENZA, including viral pneumonia (0.8%) and aspiration pneumonia (0.4%)
Among patients who received MARGENZA + chemotherapy1
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13% reported IRRs
- In patients who experience mild or moderate IRRs, consider premedications, including antihistamines, corticosteroids, and antipyretics
- 1.9% experienced left ventricular dysfunction (LVD)
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3% discontinued permanently due to an adverse reaction
- >1% discontinued permanently due to LVD and IRRs
Premedications in the SOPHIA trial1
Premedications and prophylaxis for chemotherapy1
- In the SOPHIA trial, standard premedications for the administration of the cytotoxic chemotherapy were employed. For chemotherapy, recommendations made in the locally approved label should be followed for each agent
- When MARGENZA infusions coincided on the same day with cytotoxic chemotherapy administration, the same premedications for the chemotherapy were employed
- The following premedications were made available as per the SOPHIA trial protocol and were given to a patient within 30 minutes prior to administering MARGENZA on those days upon which that administration was not preceded by a chemotherapeutic agent or if no premedication was employed for that chemotherapy
- Acetaminophen 650 mg-1000 mg orally (PO) or ibuprofen 400 mg PO
- Diphenhydramine 50 mg PO or IV or equivalent H1 antagonist
- Ranitidine§ 300 mg PO or IV or equivalent H2 antagonist
- Dexamethasone 10 mg IV or equivalent (for patients at high risk)
§Effective April 1, 2020, the FDA requested manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from market.
H1 antagonist=histamine H1 receptor antagonist; H2 antagonist=histamine H2 receptor antagonist; IV=intravenous.
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Request a repReferences: 1. MARGENZA® (margetuximab-cmkb). Prescribing Information. TerSera Therapeutics LLC. 2. Rugo HS, Im SA, Cardoso F, et al. Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer: a phase 3 randomized clinical trial. JAMA Oncol. 2021;7(4):573-584. doi:10.1001/jamaoncol.2020.7932
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
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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.
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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
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Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment.
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In the pivotal SOPHIA trial, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
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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
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Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman.
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Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
Infusion-Related Reactions (IRRs)
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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.
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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.
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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.