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Dosing and Administration

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MARGENZA allows for flexibility in physician's choice of chemotherapy combination1

In the SOPHIA trial, MARGENZA was paired with physician's choice of four different chemotherapy options:

  • Capecitabine
  • Eribulin
  • Gemcitabine
  • Vinorelbine

Recommended dosage and administration1

Dose

IV 15 mg/kg

Initial Infusion

Over 120 minutes

Subsequent Infusion

Over 30 minutes (minimum)
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 premedication, 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.

Administering MARGENZA

Preparation for intravenous infusion1

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

  1. 1. 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
  2. 2. Swirl the vial(s) gently. Do not shake the vial(s)
  3. 3. 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
  4. 4. Withdraw appropriate volume of MARGENZA solution from the vial(s) using a syringe
  1. 5. 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
  2. 6. The final concentration of the diluted solution should be between 0.5 mg/mL to 7.2 mg/mL
  3. 7. Gently invert the intravenous bag to mix the diluted solution. Do not shake the intravenous bag
  4. 8. 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.

Administration of diluted solution1

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 co-administer other drugs through the same infusion line.

Storage of diluted solution1

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.

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Reference: 1. MARGENZA® (margetuximab-cmkb). Prescribing Information. TerSera Therapeutics LLC.

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.

Important Safety Information

BOXED 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.

Additional Important Safety Information

Left Ventricular Dysfunction

  • •

    Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment.

  • •

    In the pivotal SOPHIA trial, 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.

Embryo-Fetal Toxicity

  • •

    Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman.

  • •

    Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.

Infusion-Related Reactions (IRRs)

  • •

    MARGENZA can cause IRRs. Monitor patients during and after MARGENZA infusion for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies.

  • •

    In the pivotal SOPHIA trial, 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.

  • •

    Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve.

Most Common Adverse Reactions

The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy in order of frequency are 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, and extremity pain.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1‑844‑334‑4035 or medicalinformation@tersera.com.

Please see accompanying Full Prescribing Information, including Boxed Warning.

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.

BOXED 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.

Additional Important Safety Information

Left Ventricular Dysfunction

  • •

    Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment.

  • •

    In the pivotal SOPHIA trial, 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.

Embryo-Fetal Toxicity

  • •

    Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman.

  • •

    Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.

Infusion-Related Reactions (IRRs)

  • •

    MARGENZA can cause IRRs. Monitor patients during and after MARGENZA infusion for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies.

  • •

    In the pivotal SOPHIA trial, 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.

  • •

    Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve.

Most Common Adverse Reactions

The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy in order of frequency are 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, and extremity pain.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1‑844‑334‑4035 or medicalinformation@tersera.com.

Please see accompanying Full Prescribing Information, including Boxed Warning.