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MARGENZA allows for flexibility in chemotherapy combination choice

MARGENZA is indicated to be used in combination with chemotherapy1

Chemotherapy can be tailored to patient needs

MARGENZA is indicated in combination with chemotherapy.

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.

Dose Initial Infusion
Infusion bag icon Infusion
15
mg/kg
Clock icon Over
120
minutes
Subsequent Infusion
Clock icon Over
30
minutes
(minimum)
Calendar icon Every
21
days

Continue MARGENZA until disease progression or unacceptable toxicity

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.

Checklist for Managing Infusion-Related Reactions (IRRs)

Consider premedications, including antihistamines, corticosteroids, and antipyretics, in patients who experience mild or moderate IRRs
Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with medical therapy which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen
Decrease the rate of infusion for mild or moderate IRRs
Evaluate and carefully monitor patients until complete resolution of signs and symptoms
Discontinue MARGENZA permanently in all patients with severe or life-threatening IRRs

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.; 2023.

When to consider MARGENZA
for patients with HER2+ mBC

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IMPORTANT SAFETY INFORMATION

WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

  • 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.
  • Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.
WARNINGS & PRECAUTIONS:
Left Ventricular Dysfunction
  • Left ventricular cardiac dysfunction can occur with MARGENZA.
  • In SOPHIA, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
  • 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.
  • Withhold MARGENZA for ≥16% absolute decrease in LVEF from pretreatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
  • Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
  • 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 LVEF by echocardiogram or MUGA scan.
  • Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.
Embryo-Fetal Toxicity
  • Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
  • Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
  • Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
  • Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.
Infusion-Related Reactions (IRRs)
  • MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
  • In SOPHIA, 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.
  • Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
  • In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
  • Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.
MOST COMMON ADVERSE REACTIONS:

The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

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.

Please see full Prescribing Information, including Boxed Warning.