MARGENZA (margetuximab-cmkb) allows for flexibility in
chemotherapy combination choice

Chemotherapy can be tailored to patient needs

MARGENZA is indicated in combination with chemotherapy after two or more prior anti-HER2 regimens, at least one of which for metastatic disease.

MARGENZA and Chemotherapy for HER2-positive Metastatic Breast Cancer

In the Pivotal SOPHIA trial, MARGENZA was paired with 4 different chemotherapy options:

• Capecitabine
• Eribulin
• Gemcitabine
• Vinorelbine

Recommended dosage and administration

See below for Preparation for Administration.

If a patient misses a dose of MARGENZA, administer the scheduled dose as soon as possible. Adjust the administration schedule to maintain a 21-day interval between doses.

On days when both MARGENZA and chemotherapy are to be administered, MARGENZA may be administered immediately after chemotherapy completion.

Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of left ventricular ejection fraction (LVEF) by echocardiogram or MUGA scan. Withhold MARGENZA dosing for at least 4 weeks for any of the following:

• ≥16% absolute decrease in LVEF from pretreatment values
• LVEF below institutional limits of normal (or 50% if no limits are available) and ≥10% absolute decrease in LVEF from pretreatment values

MARGENZA dosing may be resumed if, within 8 weeks, LVEF returns to normal limits and absolute decrease from baseline is ≤15%. Permanently discontinue MARGENZA if LVEF decline persists for greater than 8 weeks, or if dosing is interrupted on greater than 3 occasions for LVEF decline.

Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.

Preparation for Administration¹

Preparation for Intravenous Infusion

Prepare solution for infusion, using aseptic technique, as follows:

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution is clear to slightly opalescent, colorless to pale yellow or pale brown. Some visible, translucent, inherent proteinaceous particles may be present
• Swirl the vial(s) gently. Do not shake the vial(s)
• Calculate the required volume of MARGENZA needed to obtain the appropriate dose according to patient’s body weight. The calculated total dose volume should be rounded to the nearest 0.1 mL
• Withdraw appropriate volume of MARGENZA solution from the vial(s) using a syringe
• Transfer MARGENZA into an intravenous bag containing 100 mL or 250 mL 0.9% Sodium Chloride Injection, USP. PVC intravenous bags or intravenous bags made with polyolefins (polyethylene and polypropylene) and polyamide or polyolefins only or copolymer of olefins may be used. Do not use 5% Dextrose Injection, USP solution
• The final concentration of the diluted solution should be between 0.5 mg/mL to 7.2 mg/mL
• Gently invert the intravenous bag to mix the diluted solution. Do not shake the intravenous bag
• Discard any unused portion left in the vial(s)

Do not administer as an intravenous push or bolus. Do not mix MARGENZA with other drugs.

Storage of Diluted Solution

The product does not contain a preservative. If diluted infusion solution is not used immediately, it can be stored at room temperature up to 4 hours or stored refrigerated at 2°C to 8°C (36°F to 46°F) up to 24 hours. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Do not freeze.

Administration

• Administer diluted infusion solution intravenously over 120 minutes for the initial dose, then over a minimum of 30 minutes every 3 weeks for all subsequent doses. Administer through an intravenous line containing a sterile, non pyrogenic, low protein binding PES 0.2 micron in line or add on filter
• Do not coadminister other drugs through the same infusion line

Storage

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light until time of use. Do not freeze. Do not shake.

How Supplied

MARGENZA injection is a clear to slightly opalescent, colorless to pale yellow or pale brown solution in a single dose vial supplied as:

Carton Contents	NDC
One 250 mg/10mL (25 mg/mL) single-dose vial	NDC 74527-022-02
Four 250 mg/10mL (25 mg/mL) single-dose vials	NDC 74527-022-03

NDC=National Drug Code; PES=polyethersulfone; PVC=polyvinyl chloride; USP=United States Pharmacopeia.

Reference:

1. MARGENZA Prescribing Information. MacroGenics, Inc.