Margetuximab
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. 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. ( 2.2 , 5.1 , 6.1 ) Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.
( 5.2 , 8.1 , 8.3 ) 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 [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ]. Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1 , 8.3) ].
HER2/neu Receptor Antagonist
Dosing in kidney impairment
In an animal reproduction study, intravenous administration of margetuximab-cmkb to pregnant cynomolgus monkeys once every 3 weeks starting at gestational day (GD) 20 until delivery resulted in oligohydramnios and delayed infant kidney development. Animal exposures were ≥ 3 times the human exposures at the recommended dose, based on C max .
Preparation and administration
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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 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. 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. 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 polyethersulfone (PES) 0.2 micron in-line or add-on filter.
Do not co-administer other drugs through the same infusion line.
Drug interactions
Check margetuximab against a medication listLabel text (1 paragraph)
Anthracyclines Patients who receive anthracyclines less than 4 months after stopping MARGENZA [see Clinical Pharmacology (12.3) ] 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 MARGENZA. If concomitant use is unavoidable, closely monitor patient's cardiac function.
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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.
In an animal reproduction study, intravenous administration of margetuximab-cmkb to pregnant cynomolgus monkeys once every 3 weeks, starting at gestational day (GD) 20 until delivery, resulted in oligohydramnios and delayed infant kidney development. Animal exposures were ≥ 3 times the human exposures at the recommended dose, based on C max (see Data ) . Advise patients of potential risks to a fetus. There are clinical considerations if MARGENZA is used during pregnancy or within 4 months prior to conception (see Clinical Considerations ). Estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.
general population, background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 - 4% and 15 - 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Monitor women who received MARGENZA during pregnancy or within 4 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care. Data Animal Data In an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received intravenous doses of 50 or 100 mg/kg margetuximab-cmkb once every 3 weeks starting on GD 20 and until delivery.
Animal exposures at doses of 50 and 100 mg/kg were 3 and 6 times, respectively, the human exposures at the recommended dose, based on C max . Treatment with 50 and 100 mg/kg margetuximab-cmkb resulted in oligohydramnios beginning on GD 75. An infant mortality occurred on post-natal day 63 following maternal exposure to 100 mg/kg margetuximab-cmkb. Clinical findings included tubular degeneration/necrosis and tubular dilatation in the kidney. Maternal doses of 50 and 100 mg/kg resulted in decreased infant kidney weights and histologic immature nephrons.
Measurable serum concentrations of margetuximab-cmkb were observed in infant animals, which is consistent with margetuximab-cmkb crossing the placenta.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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