Margetuximab Application Scope

Indicated, in combination with chemotherapy, for the treatment of 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.

Margetuximab Characteristics

Ingredients: Margetuximab-cmkb
Properties: Human/mouse chimeric Fc-engineered IgG1 kappa monoclonal antibody; clear to slightly opalescent, colorless to pale yellow or pale brown solution.
Packaging Specification: Vial containing 250 mg/10 mL of Margetuximab-cmkb concentrate for solution for infusion.
Storage: Refrigerate at $2^{\circ} C$ to $8^{\circ} C$ ( $3 6^{\circ} F$ to $4 6^{\circ} F$ ) in the original carton to protect from light.
Expiry Date: Not universally available; refer to the manufacturer’s labeling on the package for the specific product’s expiration date.
Executive Standard: According to the manufacturer’s internal quality standard and relevant regulatory guidelines.
Approval Number: Refer to the approved local regulatory registration number.
Date of Revision: Refer to the latest version of the manufacturer’s Full Prescribing Information.
Manufacturer: MacroGenics, Inc. (Marketed under the brand name Margenza).

Guidelines for the Use of Margetuximab

Dosage and Administration:
- Recommended Dose: 15 mg/kg intravenously every 3 weeks, in combination with chemotherapy.
- Administration: Infuse over approximately 120 minutes for the first dose, and 30 minutes for subsequent doses if tolerated. Do not administer as an IV push or bolus.
- Missed Dose: If a scheduled dose is missed, administer it as soon as possible; do not double the next dose.
Adverse Reactions:
- Common Adverse Reactions: Fatigue, nausea, diarrhea, infusion-related reactions, vomiting, headache, and fever.
- Serious Adverse Reactions: Infusion-related reactions, cardiotoxicity, and severe hypersensitivity reactions.
Contraindications: No specific contraindications are listed in the FDA Prescribing Information, but the Boxed Warnings regarding Left Ventricular Dysfunction and Embryo-Fetal Toxicity are critical considerations.
Precautions:
- Monitor cardiac function before and during treatment.
- Observe patients for infusion-related reactions.
- Use caution in patients with a history of congestive heart failure or cardiac dysfunction.

Margetuximab Interactions

No specific drug-drug interaction studies have been conducted. Avoid or use alternate drugs when considering a combination with other immunosuppressive therapies due to the potential for additive immune system effects and risk of infection.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.