Dosing and administration
See how to properly administer MARGENZA
Dosing informationHow to Order MARGENZA
For illustration only.
How MARGENZA is supplied
MARGENZA injection is a clear to slightly opalescent, colorless to pale yellow or pale brown solution in a single-dose vial supplied as:
| Carton contents | NDC |
|---|---|
| One 250 mg/10 mL (25 mg/mL) single-dose vial | NDC 70720‑022‑02 |
NDC=National Drug Code.
Storage and handling
Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light until time of use. Do not freeze. Do not shake.
Authorized distributors
To order MARGENZA, contact these authorized distributors directly:
- ASD Healthcare
- 1‑800‑746‑6273
- Cardinal Health Specialty Distribution
- 1‑877‑453‑3972
- McKesson Plasma and Biologics
- 1‑877‑599‑7748
- McKesson Specialty Care Distribution
- 1‑800‑482‑6700
- Oncology Supply
- 1‑800‑633‑7555
Coding and reimbursement
Billing and Coding Guide
Includes potential billing codes for MARGENZA (see below for list), as well as sample claim forms for physician’s office setting and institutional or hospital setting. Download to have as a reference.
Download guidePotential billing codes for MARGENZA
TerSera Therapeutics has identified the potential billing codes below to assist HCPs with obtaining insurance reimbursement for MARGENZA and its administration.
Please note that coverage, coding, and payment may vary significantly by patient, payer, plan, treatment setting, and site of care. TerSera Therapeutics makes no representation, warranty, or guarantee that the information provided herein is up to date and/or accurate, will satisfy the requirements of the patient’s insurer or payer, or result in payment. All codes included in this guide are for informational purposes only and do not guarantee payment of any claim. It is the sole responsibility of HCPs to select the appropriate codes and ensure the accuracy of all claims submitted for reimbursement.
ICD-10-CM Diagnosis Codes1 + −
| Codes | Category of treatment or description |
|---|---|
| C50.011-C50.019, C50.111-C50.119, C50.211-C50.219, C50.311-C50.319, C50.411-C50.419, C50.511-C50.519, C50.611-C50.619, C50.811-C50.819, C50.911-C50.919 | Malignant neoplasm of female breast |
| C50.021-C50.029, C50.121-C50.129, C50.221-C50.229, C50.321-C50.329, C50.421-C50.429, C50.521-C50.529, C50.621-C50.629, C50.821-C50.829, C50.921-C50.929 | Malignant neoplasm of male breast |
Permanent HCPCS J-code2* + −
| Codes | Category of treatment or description |
|---|---|
| J9353 | Injection, margetuximab-cmkb, 5 mg |
| *Effective for dates of service on or after July 1, 2021. | |
National Drug Codes + −
| 10-digit NDC3 | 11-digit NDC3,4 | Category of treatment or description |
|---|---|---|
| 74527-022-02 | 74527-0022-02 | One (25 mg/mL) single-dose vial |
CPT® Procedure Codes5 + −
| Codes | Category of treatment or description |
|---|---|
| 96413 | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96415 | Chemotherapy administration, intravenous infusion technique; each additional hour (list separately in addition to code for primary procedure) |
| 96417 | Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour (list separately in addition to code for primary procedure) |
AHA Revenue Codes6 + −
| Codes | Category of treatment or description |
|---|---|
| 0335 | Chemotherapy administration, intravenous |
| 0636 | Drugs requiring detailed coding |
| 0250 | Pharmacy, general |
| 0260 | Intravenous therapy, general |
CPT® is a registered trademark of the American Medical Association.
AHA=American Hospital Association; CPT®=Current Procedural Terminology®; HCPCS=Healthcare Common Procedural Coding System; ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification.
Prior authorization support
In the event that prior authorization is necessary, prior authorization support may be provided by TerSera SupportSource for MARGENZA. Make sure that patients have a benefit verification completed as part of enrolling in TerSera SupportSource for MARGENZA via the Co-pay Assistance Program Enrollment Form.
Appeals support
If a claim is denied, TerSera SupportSource for MARGENZA can help by providing customized support for each case. Because each claim is different, we can help you create an appeal letter based on the reason for denial. Please contact TerSera SupportSource for MARGENZA for assistance at 1‑833‑377‑HER2 (4372), Monday–Friday 9 AM to 6 PM ET. Use of the letter is not intended to substitute for the medical judgment of the healthcare provider; nor does it guarantee insurance company will approve coverage of MARGENZA.
Financial support
Explore support options to help your patients access MARGENZA
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Request a repReferences: 1. Centers for Medicare and Medicaid Services. ICD-10 Code Lookup. Accessed December 16, 2025. https://www.cms.gov/icd10manual/version33-fullcode-cms/fullcode_cms/P0229.html 2. Centers for Medicare & Medicaid Services. Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions First Quarter 2021 Coding Cycle for Drug and Biological Products. Accessed December 16, 2025. https://www.cms.gov/files/document/2021-hcpcs-application-summary-quarter-1-2021-drugs-and-biologics-updated-05262021.pdf 3. MARGENZA® (margetuximab-cmkb). Prescribing Information. TerSera Therapeutics LLC. 4. Federal Register. Future Format of the National Drug Code; Public Hearing; Request for Comments. Vol 83, No. 152. Published August 7, 2018. Accessed December 16, 2025. https://www.federalregister.gov/documents/2018/08/07/2018-16807/future-format-of-the-national-drug-code-public-hearing-request-for-comments 5. Synovec MS, Brin KP, Jagmin CL, et al, eds. CPT 2020 Professional Edition. Chicago, IL: American Medical Association; 2019. 6. Centers for Medicare & Medicaid Services. Medicare Intermediary Manual. Transmittal 1875. Published February 7, 2003. Accessed December 16, 2025. https://www.cms.gov/regulations-and-guidance/guidance/transmittals/downloads/r1875a3.pdf
Indication
MARGENZA is a HER2/neu receptor antagonist 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.
Important Safety Information
BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY
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•
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.
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Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.
Additional Important Safety Information
Left Ventricular Dysfunction
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Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment.
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In the pivotal SOPHIA trial, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
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MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction, or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
Embryo-Fetal Toxicity
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Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman.
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Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
Infusion-Related Reactions (IRRs)
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MARGENZA can cause IRRs. Monitor patients during and after MARGENZA infusion for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies.
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In the pivotal SOPHIA trial, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.
- •
Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve.
Most Common Adverse Reactions
The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy in order of frequency are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1‑844‑334‑4035 or medicalinformation@tersera.com.
Please see accompanying Full Prescribing Information, including Boxed Warning.