Breast cancer:

Indications for: MARGENZA

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.

Adult Dosage:

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 Dosage:

Not established.

Boxed Warning:

Left ventricular dysfunction. Embryo-fetal toxicity.

MARGENZA 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 Classification:

HER2/neu receptor antagonist.

MARGENZA Interactions:

Avoid anthracycline-based therapy for up to 4 months after discontinuing Margenza; if unavoidable, closely monitor cardiac function.

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.

Generic Drug Availability:


How Supplied:

Single-dose vials (10mL)—1, 4