NDC CODE ANNOUNCEMENT

NEW NDC for HERCESSI^™ (trastuzumab-strf) 420mg multiple-dose vial co-packaged with Bacteriostatic Water for Injection, USP¹

Billed under the existing HCPCS code Q5146

Accord BioPharma Inc. has launched a new National Drug Code (NDC), 69448-0035-63, for HERCESSI^™ (trastuzumab-strf) 420mg multiple-dose vial for injection co-packaged with 20mL Bacteriostatic Water for Injection, USP (BWFI)¹. This new presentation bills under the existing HCPCS code Q5146, which is already active.

Please see below for Important Safety Information including Boxed Warning for HERCESSI.

^*The 11-digit NDC code shown is used for claims processing and reimbursement. The corresponding 10-digit NDC code is 69448-035-63.

HERCESSI^™ (trastuzumab-strf) for injection, for intravenous use

HERCESSI (trastuzumab-strf) is biosimilar to HERCEPTIN^® (trastuzumab).

Cardiomyopathy

• Trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
• Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF)
• Discontinue HERCESSI treatment in patients receiving adjuvant therapy and withhold HERCESSI in patients with metastatic disease for clinically significant decrease in left ventricular function

Cardiac Monitoring

• Evaluate cardiac function prior to and during treatment. For adjuvant therapy, also evaluate cardiac function after completion of HERCESSI
• Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
• Monitor frequently for decreased LVEF during and after HERCESSI treatment
• Monitor more frequently if HERCESSI is withheld for significant left ventricular cardiac dysfunction

Infusion Reactions

• With trastuzumab products, serious and fatal infusion reactions have been reported
• Symptoms usually occur during or within 24 hours of trastuzumab product administration
• Interrupt HERCESSI infusion for dyspnea or clinically significant hypotension
• Monitor patients until symptoms completely resolve
• Discontinue HERCESSI for severe infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
• Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia

Embryo-Fetal Toxicity

• Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
• Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCESSI
• Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of HERCESSI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for HERCESSI treatment and any potential adverse effects on the breastfed child from HERCESSI or from the underlying maternal condition

Pulmonary Toxicity

• Trastuzumab products can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
• Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

• In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions

• The most common adverse reactions associated with trastuzumab products in breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
• The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Adjuvant Breast Cancer

HERCESSI^™ (trastuzumab-strf) is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR-negative or with one high-risk feature) breast cancer:

• as part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
• as part of a treatment regimen with docetaxel and carboplatin
• as a single agent following multi-modality anthracycline-based therapy

Metastatic Breast Cancer

HERCESSI is indicated in adults:

• in combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
• as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Metastatic Gastric Cancer

HERCESSI is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

HERCESSI^™ (trastuzumab-strf) for injection is available as a single-dose vial for the 150 mg/vial strength and as a multiple-dose vial for the 420 mg/vial strength.

Click here for full Prescribing Information, including Boxed Warnings.

Reference: 1. HERCESSI (trastuzumab-strf) Prescribing Information. Accord BioPharma, Inc.; December 2025.

HERCEPTIN^® (trastuzumab) is a registered trademark of Genentech USA, Inc.