• Full Prescribing Information, including BOXED WARNINGS
  • Medical Information
  • Pfizer is building onto the clinical experience of trastuzumab

    Dosing & Product Information

    TRAZIMERA has the same dosing and administration schedule as Herceptin® (trastuzumab)1

    • Do not administer as an intravenous push or bolus. Do not mix TRAZIMERA with other drugs

    • Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine

    Please see the full Prescribing Information for Important Dosing Considerations.​​​​​​​

    Product Information1

    ** This is an optional area where footnotes can live.

    Single- and multiple-dose options for your individual practice needs

    Efficiency in preparation and reduced waste

    Flexible storage (can be stored in or out of the refrigerator)§

    Diluent included for multiple-dose vial

    Enhanced electronic record keeping with 2-D barcode vial label

     ​​​​​​​  *NCCN Guidelines® recommend the use of an FDA-approved biosimilar as an appropriate substitute for trastuzumab. 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.

       †For multiple-dose vial, unused product can be stored for future use. Store reconstituted TRAZIMERA MDV in the refrigerator at 2°C to 8°C (36°F to 46°F); discard unused TRAZIMERA after 28 days. If TRAZIMERA is reconstituted with Sterile Water for Injection without preservative, use immediately and discard any unused portion. Do not freeze.1

       Multiple-dose feature of vials may support efficiency and reduce waste, as it allows fewer vials to be used and disposed of.

       §Store TRAZIMERA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. If needed, unopened TRAZIMERA vials may be removed from the refrigerator and stored at room temperature up to 30°C (86°F) for a single period of up to 3 months in the original carton to protect from light. Once removed from the refrigerator, do not return to the refrigerator and discard after 3 months or by the expiration date stamped on the vial, whichever occurs first. Write the revised expiration date in the space provided on the carton labeling.
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    Ordering Information

    MDV=multiple-dose vial.
    SDV=single-dose vial.

    Coding Information4

    OPPS=Outpatient Prospective Payment System.
    ​​​​​​​


    References:
    1. TRAZIMERA [prescribing information]. New York, NY: Pfizer Inc.; November 2020.
    2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2020. © 2020 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.
    3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2020. © 2020 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.
    4. Centers for Medicare & Medicaid Services. July 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS). Updated July 1, 2020.

    FDA-approved biosimilars such as trastuzumab-qyyp (TRAZIMERA™) are recommended as treatment options in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)​​​​​​​2,3*

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    Card CTA

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    Learn more about the TRAZIMERA clinical data in support of biosimilarity

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    Download the Product Monograph

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    IndicationS

    Adjuvant Breast Cancer

    TRAZIMERA 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 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.

    *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

    TRAZIMERA 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 a trastuzumab product.

    Metastatic Gastric Cancer

    TRAZIMERA 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 a trastuzumab product.

    BOXED WARNINGS AND ADDITIONAL IMPORTANT SAFETY INFORMATION

    Cardiomyopathy

    • 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
    • Evaluate left ventricular function in all patients prior to and during treatment with TRAZIMERA. Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERA in patients with metastatic disease for clinically significant decrease in left ventricular function

    Infusion Reactions; Pulmonary Toxicity

    • Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt TRAZIMERA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

    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

    Cardiomyopathy

    • 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 LVEF
    • Discontinue TRAZIMERA treatment in patients receiving adjuvant breast cancer therapy and withhold TRAZIMERA 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 TRAZIMERA
    • 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 TRAZIMERA treatment
    • Monitor more frequently if TRAZIMERA is withheld for significant left ventricular cardiac dysfunction

    Infusion Reactions

    • Administration of trastuzumab products can result in serious and fatal infusion reactions
    • Symptoms usually occur during or within 24 hours of administration of trastuzumab products
    • Interrupt TRAZIMERA infusion for dyspnea or clinically significant hypotension
    • Monitor patients until symptoms completely resolve
    • Discontinue TRAZIMERA 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 TRAZIMERA
    • Advise pregnant women and females of reproductive potential that exposure to TRAZIMERA 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 TRAZIMERA
    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for TRAZIMERA treatment and any potential adverse effects on the breastfed child from TRAZIMERA or from the underlying maternal condition

    Pulmonary Toxicity

    • Administration of 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 TRAZIMERA in patients experiencing pulmonary toxicity

    Exacerbation of Chemotherapy-Induced Neutropenia

    • In randomized, controlled clinical trials, the numbers of 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

    ​​​​​​​Adjuvant Breast Cancer

    TRAZIMERA 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 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.

    *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

    TRAZIMERA 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 a trastuzumab product.

    Metastatic Gastric Cancer

    TRAZIMERA 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 a trastuzumab product.

    Please see full Prescribing Information, including BOXED WARNINGS.

    TRAZIMERA is a trademark of Pfizer Inc.

    Herceptin is a registered trademark of Genentech, Inc.