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Margenza

margetuximab-cmkb
HER2 mAb FDA Approved 2020 MacroGenics
Route
IV
Half-Life
~19 days
FDA Approved
2020
Manufacturer
MacroGenics
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1. Indications and Usage

HER2+ mBC after 2+ anti-HER2 regimens.

2. Dosage and Administration

15 mg/kg IV Q3W.

3. Dosage Forms and Strengths

250 mg/10 mL vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Cardiomyopathy: Assess LVEF.
  • Infusion Reactions: Monitor.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Fatigue (32%), Nausea (29%), Diarrhea (25%), Infusion Reactions (13%), Cough (14%), Headache (12%)

Fatigue
32%
Nausea
29%
Diarrhea
25%
Infusion Reactions
13%
Cough
14%
Headache
12%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No CYP interactions.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Fc-engineered anti-HER2 mAb with enhanced ADCC.

Pharmacokinetics

t1/2: ~19 days.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
FDA-Approved Tumor Types

Margenza has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Margenza. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Margenza (margetuximab-cmkb) approved for?

Margenza (margetuximab-cmkb) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Margenza (margetuximab-cmkb) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Margenza (margetuximab-cmkb) work?

Fc-engineered anti-HER2 mAb with enhanced ADCC.

What are the most common side effects?

Fatigue (32%), Nausea (29%), Diarrhea (25%), Infusion Reactions (13%), Cough (14%), Headache (12%) Fatigue 32% Nausea 29% Diarrhea 25% Infusion Reactions 13% Cough 14% Headache 12%