Brand Name
Margenza
Generic Name
Margetuximab-Cmkb
View Brand Information FDA approval date: January 15, 2021
Classification: HER2/neu Receptor Antagonist
Form: Injection
What is Margenza (Margetuximab-Cmkb)?
MARGENZA is 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 [see Dosage and Administration.
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Brand Information
MARGENZA (margetuximab-cmkb)
1INDICATIONS AND USAGE
MARGENZA is 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
2DOSAGE FORMS AND STRENGTHS
Injection: 250 mg/10 mL (25 mg/mL) clear to slightly opalescent, colorless to pale yellow or pale brown solution in a single-dose vial.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Left Ventricular Dysfunction
- Embryo-Fetal Toxicity
- Infusion-Related Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.
The safety of MARGENZA was evaluated in HER2-positive breast cancer patients who received two or more prior anti-HER2 regimens in SOPHIA
Patients were randomized (1:1) to receive either MARGENZA 15 mg/kg every 3 weeks plus chemotherapy or trastuzumab plus chemotherapy. Among patients who received MARGENZA, 40% were exposed for 6 months or longer and 11% were exposed for greater than one year.
Serious adverse reactions occurred in 16% of patients who received MARGENZA. Serious adverse reactions in > 1% of patients included febrile neutropenia (1.5%), neutropenia/neutrophil count decrease (1.5%) and infusion related reactions (1.1%). Fatal adverse reactions occurred in 1.1% of patients who received MARGENZA, including viral pneumonia (0.8%) and aspiration pneumonia (0.4%).
Permanent discontinuation due to an adverse reaction occurred in 3% of patients who received MARGENZA. Adverse reactions which resulted in permanent discontinuation in > 1% of patients who received MARGENZA included left ventricular dysfunction and infusion-related reactions.
Dosage interruptions due to an adverse reaction occurred in 11% of patients who received MARGENZA. Adverse reactions which required dosage interruption in > 5% of patients who received MARGENZA included infusion-related reactions.
Table 1 summarizes the adverse reactions in SOPHIA.
Clinically relevant adverse reactions in ≤10% of patients who received MARGENZA in combination with chemotherapy included: dizziness and stomatitis (10%) each, decreased weight, dysgeusia, rash, and insomnia (6%) each, hypertension (5%), and syncope (1.5%).
Table 2 summarizes the laboratory abnormalities in SOPHIA.
5DESCRIPTION
Margetuximab-cmkb, a HER2/neu receptor antagonist, is a chimeric Fc-engineered IgG1 kappa monoclonal antibody.
Margetuximab-cmkb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Margetuximab-cmkb has an approximate molecular weight of 149 kDa.
MARGENZA (margetuximab-cmkb) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow or pale brown solution that requires dilution for intravenous use. Some visible, translucent, inherent proteinaceous particles may be present. Each single-dose vial contains 250 mg of margetuximab-cmkb in 10 mL of solution. Each mL of solution contains 25 mg of margetuximab-cmkb, L-arginine hydrochloride (11 mg), polysorbate 80 (0.1 mg), sodium chloride (2.9 mg), sodium phosphate dibasic, heptahydrate (0.58 mg), sodium phosphate monobasic, monohydrate (1.1 mg), sucrose (30 mg), and Water for Injection, USP at a pH of approximately 6.1.
6PRINCIPAL DISPLAY PANEL - 250 mg/10 mL Vial Carton
Rx only
NDC 70720-022-02
Margenza
250 mg/10 mL
For Intravenous Infusion After Dilution
1 Vial
