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Margetuximab-Cmkb

Also known as: Margenza

HER2/neu Receptor AntagonistHER2/Neu/cerbB2 Antagonists

Route: Intravenous

2 interactions on record⛔ Black Box Warning

Margetuximab-Cmkb has 2 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Anthracycline, Tetracycline. Patients taking Margetuximab-Cmkb should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Major: 2

Major (2)

Margetuximab-Cmkb + Anthracycline— 7 DRUG INTERACTIONS Anthracyclines Patients who receive anthracyclines less than 4 months after stopping MARGENZA [see C…
Margetuximab-Cmkb + Tetracycline— Patients receiving anthracyclines less than 4 months after stopping MARGENZA may be at increased risk of cardiac dysfunc…

Margetuximab-Cmkb + Anthracycline⚠️Major

7 DRUG INTERACTIONS 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. Avoid anthracycline-based therapy for up to 4 months after stopping MARGENZA.

Margetuximab-Cmkb + Tetracycline⚠️Major

Patients receiving anthracyclines less than 4 months after stopping MARGENZA may be at increased risk of cardiac dysfunction. Avoid anthracycline-based therapy for up to 4 months after stopping MARGENZA.

⛔ FDA Black Box 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) ].

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy & Breastfeeding

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 margetuxi

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.