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Margenza Generic Name & Formulations
Legal Class
Rx
General Description
Margetuximab-cmkb 250mg; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
HER2/neu receptor antagonist.
How Supplied
Single-dose vials (10mL)—1, 4
Manufacturer
Generic Availability
NO
Margenza Indications
Indications
In combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer who have received ≥2 prior anti-HER2 regimens, at least 1 of which was for metastatic disease.
Margenza Dosage and Administration
Adult
Give by IV infusion over 120mins for the initial dose, then over a minimum of 30mins for all subsequent doses. 15mg/kg every 3 weeks until disease progression or unacceptable toxicity. Administer Margenza immediately after chemotherapy on days when both are administered. Dose modification: see full labeling.
Children
Not established.
Margenza Contraindications
Not Applicable
Margenza Boxed Warnings
Boxed Warning
Left ventricular dysfunction. Embryo-fetal toxicity.
Margenza Warnings/Precautions
Warnings/Precautions
Risk of left ventricular dysfunction. Pretreatment LVEF <50%, prior history of MI or unstable angina within 6 months, or CHF NYHA (class II-IV): not studied. Conduct cardiac evaluation including history, physical exam, and LVEF by ECG or MUGA scan. Assess baseline LVEF within 4 weeks prior to initiation, then every 3 months (during and upon therapy completion). Repeat LVEF measurement every 4 weeks, if treatment is withheld for significant left ventricular dysfunction. Monitor for infusion-related reactions. Have medications and resuscitative equipment available. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: consider washout period for 4 months.
Margenza Pharmacokinetics
See Literature
Margenza Interactions
Interactions
Avoid anthracycline-based therapy for up to 4 months after discontinuing Margenza; if unavoidable, closely monitor cardiac function.
Margenza Adverse Reactions
Adverse Reactions
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, extremity pain; lab abnormalities.
Margenza Clinical Trials
See Literature
Margenza Note
Not Applicable
Margenza Patient Counseling
See Literature
