TM Owner MacroGenics
Margenza 250mg/10ml Injection, solution (concentrate for further dilution)
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Indications & Clinical Uses
- Margenza 250 mg/10 mL (25 mg/mL), margetuximab-cmkb, is a HER2-targeted monoclonal antibody given by intravenous infusion.
- In the US label, it is approved, in combination with chemotherapy, for adults with metastatic HER2-positive breast cancer who have already received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
- It is a hospital- or clinic-administered, specialist oncology treatment and is not self-injected.
- Margetuximab is engineered with a modified Fc region intended to enhance immune-mediated killing of HER2-positive tumour cells, distinguishing it from other anti-HER2 antibodies such as trastuzumab; it is given together with chemotherapy, for example capecitabine, rather than as a single agent.
- Margenza is not approved for earlier lines of HER2-positive breast cancer or for other HER2-positive cancers, and testing to confirm HER2-positive status is required before starting treatment.
Side Effects
- Margenza carries a boxed warning for two serious risks.
- First, cardiac dysfunction: it can reduce the heart's pumping ability, or left ventricular ejection fraction, so heart function must be checked before treatment starts and monitored regularly during treatment, with the drug stopped if the heart is significantly affected.
- Second, embryo-fetal toxicity: exposure during pregnancy can cause serious harm to the unborn baby.
- The most common side effects, affecting more than 1 in 10 patients, are fatigue, nausea, diarrhoea, vomiting, constipation, headache, fever, hair loss and infusion-related reactions, which affected about 13% of patients, usually during the first infusion.
- Symptoms of an infusion reaction include fever, chills, flushing or breathing difficulty and should be reported to staff immediately.
- Seek urgent medical help for new or worsening shortness of breath, swelling of the legs, or a rapid or irregular heartbeat, which can signal heart problems.
Precautions & Warnings
- Left ventricular ejection fraction must be assessed before starting Margenza and monitored regularly during treatment; the drug should be withheld or permanently stopped if a significant, confirmed drop in heart function occurs.
- Because of the risk of embryo-fetal harm, women of reproductive potential should use effective contraception during treatment and for 4 months after the last dose, and pregnancy should be confirmed as excluded before starting; breastfeeding is not recommended during treatment and for a period afterward.
- Margenza is given only by intravenous infusion in a monitored clinical setting, with premedication and slower infusion rates used to manage or prevent infusion-related reactions; it must never be given as a rapid intravenous push or bolus.
- Patients should not receive live vaccines close to treatment without discussing this with the oncology team.
- Vials must be stored refrigerated at 2°C to 8°C, protected from light, must not be frozen, and must not be shaken.
Avoid Interactions
- There is limited formal drug-interaction data for Margenza, but because it is combined with chemotherapy, the combined cardiac and infusion-related risks of both medicines must be managed together; heart function is monitored more closely when Margenza is combined with other potentially cardiotoxic cancer treatments.
- Live vaccines should be avoided close to Margenza treatment because of the risk of reduced vaccine response or infection in an immune-compromised patient.
- Medicines that could mask or worsen infusion-related reactions, such as other agents causing fever or flushing, should be used cautiously and discussed with the treating oncologist.
- The oncology team reviews all other prescription medicines, over-the-counter products and supplements before each infusion.
- Margenza must be diluted only as directed and must not be mixed or administered through the same line as other medicines without pharmacy confirmation of compatibility.
References
Frequently Asked Questions
Margenza (margetuximab-cmkb) treats metastatic HER2-positive breast cancer in adults. It's used with chemotherapy after you've already had two or more prior anti-HER2 treatments, including at least one for metastatic disease. HER2-positive status must be confirmed by testing first.
Margenza is given by intravenous infusion every 3 weeks in a hospital or clinic, alongside chemotherapy. The first infusion takes about 120 minutes; later infusions can take as little as 30 minutes if well tolerated.
Margenza has a boxed warning for heart problems, reduced ejection fraction, and for harm to an unborn baby. Common side effects include fatigue, nausea, diarrhoea, vomiting, headache, hair loss and infusion reactions, which most often happen during the first dose.
Avoid becoming pregnant during Margenza treatment and for 4 months afterward, using effective contraception, because of the boxed warning for fetal harm. Avoid live vaccines around treatment, and tell your oncology team about all other medicines you take.
A nurse gives Margenza into a vein over 30 to 120 minutes, watching for infusion reactions like fever, chills or flushing, especially during your first dose. Your heart function is also checked with tests before treatment starts and at regular intervals.
No. Margenza carries a boxed warning that it can cause serious harm to an unborn baby, so effective contraception is required during treatment and for 4 months after the last dose. Tell your doctor immediately if you become pregnant.
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