Generic drug: margetuximab-cmkb
Brand name: Margenza
What is Margenza (margetuximab-cmkb), and how does it work?
Margenza (margetuximab-cmkb) is a HER2/neureceptor antagonist indicated, in combination with chemotherapy, to treat 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.
What are the side effects of Margenza?
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.
Toxicity: Exposure to Margenza during pregnancy can cause embryofetal
harm. Advise patients of the risk and need for effective contraception.
Side effects of
Margenza in combination with chemotherapy include:
- hair loss,
- abdominal pain,
- numbness and tingling in extremities,
- joint or muscle pain,
- decreased appetite,
- shortness of breath,
- infusion-related reactions,
- hand-foot syndrome (palmar-plantar erythrodysesthesia), and
- extremity pain
What is the dosage for Margenza?
Recommended Doses And Schedules
- The recommended dose of Margenza is 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
- Administer Margenza as an intravenous infusion at 15 mg/kg over 120 minutes for the initial dose, then over a minimum of 30 minutes every 3 weeks for all subsequent doses.
- On days when both Margenza and chemotherapy are to be administered,
Margenza may be administered immediately after chemotherapy completion.
- Refer to the respective Prescribing Information for each therapeutic agent administered in combination with
Margenza for the recommended dosage information, as appropriate.
Dose Modification Or Important Dosing Considerations
- If a patient misses a dose of Margenza, administer the scheduled dose as soon as possible. Adjust the administration schedule to maintain a 3-week interval between doses.
Left Ventricular Dysfunction
Assess left ventricular ejection fraction (LVEF) before starting
Margenza and regularly during treatment. Withhold Margenza dosing for at least 4 weeks for any of the following:
- ≥ 16% absolute decrease in LVEF from pre-treatment 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.
- Decrease the rate of infusion for mild or moderate infusion-related reactions (IRRs). Interrupt the infusion for dyspnea or clinically significant hypotension.
- Permanently discontinue Margenza dosing in patients with severe or life-threatening IRRs.
Preparation For Administration
Administer as an intravenous infusion after dilution.
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 patientâ€™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.
Margenza into an intravenous bag containing 100 mL or 250 mL 0.9% Sodium Chloride Injection, USP. Polyvinyl chloride (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.
- 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, lowprotein binding polyethersulfone (PES) 0.2 micron in-line or add-on filter.
- Do not co-administer other drugs through the same infusion line.
What drugs interact with Margenza?
- Patients who receive anthracyclines less than 4 months after stopping
Margenza may be at increased risk of cardiac dysfunction.
- While this interaction has not been studied with Margenza, clinical data from other HER2-directed antibodies warrants consideration.
- Avoid anthracycline-based therapy for up to 4 months after stopping
- If concomitant use is unavoidable, closely monitor patient’s cardiac function.
Is Margenza safe to use while pregnant or breastfeeding?
- Based on findings in animals and mechanism of action, Margenza can cause fetal harm when administered to a pregnant woman.
- There are no available data on use of Margenza in pregnant women to inform the drug-associated risk.
- In postmarketing reports, use of a HER2- directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
- There is no information regarding presence of Margenza in human milk, effects on the breastfed child, or effects on milk production.
- Published data suggest human IgG is present in human milk but does not enter neonatal or infant circulation in substantial amounts.
- Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for
Margenza treatment and any potential adverse effects on the breastfed child from
Margenza or from the underlying maternal condition. This consideration should also take into account the
Margenza washout period of 4 months.
Medically Reviewed on 3/9/2021
All sections courtesy of the U.S. Food and Drug Administration
- COVID case rates hit new high for England, study finds - April 7, 2022
- Govt’s focus on affordable healthcare ensured significant savings for poor, middle class: PM Modi - April 7, 2022
- SRL Diagnostics and Skye Air Mobility collaborate to transport pathology samples using drone logistics - April 6, 2022
- Healthineers sets up new production line of CT scanners in Bengaluru under PLI scheme - April 6, 2022
- Lupin inks licensing pact with Alvion to market drugs in Southeast Asia - April 6, 2022
- Yoga Mahotsav: Ayush Ministry to organise event to demonstrate common yoga on World Health Day - April 6, 2022
- LordsMed forays into the medtech space with launch of health ATMs ‘Lords Sehat’ - April 5, 2022
- ‘Friendly viruses’ can be the next big thing in the history of medical research and more - April 5, 2022
- No setback to Bharat Biotech even as WHO suspends Covaxin UN supply: Sources - April 4, 2022
- Govt panel recommends Serum’s Covovax dose for kids aged 12 and above - April 4, 2022