Herceptin® Biosimilar | KANJINTI™ (trastuzumab-anns) for HCPs_Education & Science

Indications Adjuvant Breast Cancer KANJINTI® is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*)…Read more breast cancer: KANJINTI® is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer…Read more: As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel As part of treatment 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 trastuzumab product. *High-risk is defined as ER/PR positive with one of the following features: tumor size > 2 cm, age < 35 years, or tumor grade 2 or 3. Metastatic Breast Cancer KANJINTI® is indicated: 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 Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab product. Metastatic Gastric Cancer KANJINTI® is indicated, 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 trastuzumab product. Indications Dosing Storage and Handling Prescribing Information Visit AmgenOncologyBiosimilars.com Totality of Evidence Amgen Expertise Support & Services For Patients Getting to Know KANJINTI® What is KANJINTI® Why amgen biosimilars Support About her2+ Cancer Connect with a Rep Indications Dosing Storage and Handling Prescribing Information Visit AmgenOncologyBiosimilars.com For Patients Getting to Know KANJINTI® Connect with a Rep Behind KANJINTI®THE AMGEN Experience you can trust Behind KANJINTI® THE AMGEN EXPERIENCE YOU CAN TRUST Kanjinti® The first and only Herceptin® Biosimilar with SINGLE-TRANSITION study data in the early breast cancer (eBC) setting1-8 KANJINTI® is indicated for the treatment of:1 HER2-overexpressing breast cancer HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma trastuzumab-anns (KANJINTI®) is a recommended treatment option IN THE NCCN GUIDELINES®9,* KANJINTI® The first and only Herceptin® biosimilar with SINGLE-TRANSITION study data in the early breast cancer (eBC) seTting1-8 trastuzumab-anns (KANJINTI®) is a recommended treatment option IN THE NCCN GUIDELINES®9,* KANJINTI® sets a rigorous standard for Herceptin® biosimilarity The first and onlyHerceptin® biosimilar with single-transition study data in theeBCSETTING1-8totality of evidence Identical Dosingto Herceptin® IVAvailable in a Multi-dose‡ 420 mg vial1dosing The same support you’ve come to expect from AMGENEstablished Q-code: Q5117support Backed by Amgen Expertise40+Yearsexperience in biologicsbiosimilar expertise Get the story behind Amgen's commitment to biosimilars.Amgen Biosimilars *NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recognize FDA-approved trastuzumab biosimilars for use in place of trastuzumab (Herceptin®). NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. †Current as of April 2021. ‡Multi-dose when reconstituted with Bacteriostatic Water for Injection. Privacy Statement Terms of Use Site Map Contact Us © 2021 Amgen Inc. All rights reserved. Important Safety InformationBoxed WARNINGS: Cardiomyopathy- Trastuzumab products administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients Important Safety Information Boxed WARNINGS: Cardiomyopathy- Trastuzumab products administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens Evaluate left ventricular function in all patients prior to and during treatment with KANJINTI®. Discontinue KANJINTI® treatment in patients receiving adjuvant therapy and withhold KANJINTI® in patients with metastatic disease for clinically significant decrease in Important Safety InformationImportant Safety InformationBoxed WARNINGS: Cardiomyopathy- Trastuzumab products administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens Evaluate left ventricular function in all patients prior to and during treatment with KANJINTI®. Discontinue KANJINTI® treatment in patients receiving adjuvant therapy and withhold KANJINTI® in patients with metastatic disease for clinically significant decrease in left ventricular function Infusion Reactions; Pulmonary Toxicity- Trastuzumab products administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt KANJINTI® infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue KANJINTI® for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndromeEmbryo-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 contraceptionAdditional Important Safety InformationCardiomyopathy Administration of 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. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy 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 KANJINTI® treatment in patients receiving adjuvant breast cancer therapy and withhold KANJINTI® 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 breast cancer therapy, also evaluate cardiac function after completion of KANJINTI® Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan Monitor frequently for decreased left ventricular function during and after KANJINTI® treatment Monitor more frequently if KANJINTI® is withheld for significant left ventricular cardiac dysfunction Infusion Reactions KANJINTI® administration can result in serious and fatal infusion reactions Symptoms usually occur during or within 24 hours of KANJINTI® administration Interrupt KANJINTI® infusion for dyspnea or clinically significant hypotension Monitor patients until symptoms completely resolve Discontinue KANJINTI® for 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 KANJINTI® Advise pregnant women and females of reproductive potential that exposure to KANJINTI® during pregnancy or within 7 months prior to conception can result in fetal harm Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of KANJINTI®. 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 KANJINTI® treatment and any potential adverse effects on the breastfed child from KANJINTI® 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, noncardiogenic 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 Discontinue KANJINTI® in patients experiencing pulmonary 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 were 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 You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.IndicationsAdjuvant Breast CancerKANJINTI® is indicated 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 treatment 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 trastuzumab product.*High-risk is defined as ER/PR positive with one of the following features: tumor size > 2 cm, age < 35 years, or tumor grade 2 or 3.Metastatic Breast CancerKANJINTI® is indicated: 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 Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab product.Metastatic Gastric CancerKANJINTI® is indicated, 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 trastuzumab product.Please see full Prescribing Information, including Boxed WARNINGS.Herceptin® (trastuzumab) is a registered trademark of Genentech USA, Inc. References: 1. KANJINTI® (trastuzumab-anns) Prescribing Information, Amgen. 2. von Minckwitz G, Colleoni M, Kolberg HC, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2018;19:987-998. 3. Nixon N, Hannouf M, Verma S. The evolution of biosimilars in oncology, with a focus on trastuzumab. Curr Oncol. 2018;25:S171-S179. 4. Pegram MD, Bondarenko I, Zorzetto MMC, et al. PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study. Br J Cancer. 2019;120:172-182. 5. Pivot X, Bondarenko I, Nowecki Z, et al. Phase III, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2-positive early breast cancer. J Clin Oncol. 2018;36:968-974. 6. Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017;18:917-928. 7. Chen X, Li C, Ewesudeo R, Yin D. Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer. Cancer Chemother Pharmacol. 2019;84:83-92. doi:10.1007/s00280-019-03850-1 [Epub ahead of print]. 8. Rugo HS, Barve A, Waller CF, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: a randomized clinical trial. JAMA. 2017;317:37–47. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed February 28, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. 10. Data on file, Amgen [#1 Trastuzumab Biosimilar]; 2021.