These highlights do not include all the information needed to use KANJINTI safely and effectively. See full prescribing information for KANJINTI. KANJINTI® (trastuzumab-anns) for injection, for intravenous use Initial U.S. Approval: 2019 KANJINTI (trastuzumab-anns) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of KANJINTI has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to HERCEPTIN® (trastuzumab).

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These highlights do not include all the information needed to use KANJINTI safely and effectively. See full prescribing information for KANJINTI. KANJINTI® (trastuzumab-anns) for injection, for intravenous use Initial U.S. Approval: 2019 KANJINTI (trastuzumab-anns) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of KANJINTI has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to HERCEPTIN® (trastuzumab).

Medication label

Why this: Advisory · dailymed-prescription

KANJINTI is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer as part of a treatment regimen consisting of 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. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2)]. KANJINTI is indicated in adults: In combination with paclitaxel for 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. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2)] KANJINTI 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. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2)].

generic_name: trastuzumab-anns
product_names: trastuzumab-anns
ndc: 55513-132, 55513-132-01, 55513-132-21, 55513-141, 55513-141-01, 55513-141-21
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en