Frequently Asked Questions About Margenza™ (margetuximab-cmkb)

TraceyS

Generic Name: margetuximab-cmkb
Trade Name: Margenza™

How is Margenza used? Margenza is approved for the treatment of adults with HER2-positive metastatic breast cancer who have received two or more anti-HER2 treatments (with at least one of those prior treatments for metastatic disease) in combination with chemotherapy.

Margenza labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and or life-threatening side effects including left ventricular ejection fraction (LVEF) as well as embryo-fetal harm. Pregnant women should not take Margenza.

What is the mechanism of action? Margenza is a HER2-targeting antibody. Margenza produces its anti-cancer effects by binding to and disabling a growth stimulatory pathway on cancer cells referred to as the human epidermal growth factor receptor 2 (HER2) pathway.

How is Margenza given (administered)? Margenza is administered into a vein (intravenous). Patients will be monitored during infusion for infusion-related reactions.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Margenza. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Patients will also have their heart function monitored prior to and during treatment.

What are the common side effects of Margenza in combination with chemotherapy?

  • Fatigue
  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Headache
  • Fever
  • Hair loss
  • Abdominal pain
  • Peripheral neuropathy
  • Joint and muscle pain
  • Cough
  • Decreased appetite
  • Shortness of breath
  • Infusion-related reactions
  • Redness, swelling or pain on the palms of the hands and the soles of the feet
  • Extremity pain

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Maintain adequate rest and nutrition.

Are there any special precautions patients should be aware of before starting treatment?

  • It is important that patients inform their physician of any pre-existing conditions, including heart problems.
  • Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
  • Patients should check with their physician before starting any new drug or supplement.

· Talk to your doctor if you or your partner are pregnant or planning to become pregnant. Margenza can cause fetal harm. Females should use an effective method of birth control during treatment and for four months after the last dose of Margenza.

  • Do not breastfeed during treatment or for four months after the last dose of Margenza.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor right away if you experience symptoms of left ventricular dysfunction.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated 04/21.

Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

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