Herzuma Kit
Product Images NDC 63459-305

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Herzuma (NDC 63459-305). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cephalon, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Herzuma 01)

A cumulative incidence plot showing the risk over time from initiation of Paclitaxel/Trastuzumab treatment, measured in years. The x-axis represents time in years, and the y-axis shows cumulative incidence. Two lines represent different treatment groups: AC→T and AC→T+H, with shaded confidence intervals around each line. Numbers at risk are indicated at various time points beneath the x-axis.*

FDA Label Image

Figure 2 (Herzuma 02)

A line graph showing cumulative incidence over time (months) from randomization up to 24 months, comparing Trastuzumab 1-Year treatment versus Observation Only. The graph includes a table indicating the number of subjects at risk at different time points along the x-axis.*

FDA Label Image

Figure 3 (Herzuma 03)

A cumulative incidence line graph comparing three chemotherapy regimens over 36 months. The x-axis represents time in months, and the y-axis shows cumulative incidence. Three lines represent regimens: AC->T (doxorubicin + cyclophosphamide -> docetaxel), AC->TH (doxorubicin + cyclophosphamide -> docetaxel + trastuzumab), and TCH (docetaxel + carboplatin + trastuzumab). A table below lists the number of patients at risk at intervals for each regimen.*

FDA Label Image

Figure 4 (Herzuma 04)

A line graph comparing disease-free survival over 3.5 years between two treatment groups: AC->TH (doxorubicin + cyclophosphamide followed by paclitaxel + trastuzumab) represented by a blue dashed line, and AC->T (doxorubicin + cyclophosphamide followed by paclitaxel) represented by a solid red line. The y-axis shows the proportion event-free, and the x-axis shows time in years. A risk table is included below the graph showing the number of patients at risk at various time points for both groups.*

FDA Label Image

Figure 5 (Herzuma 05)

A survival curve graph comparing proportion alive over years for two treatment groups: AC->T (doxorubicin + cyclophosphamide followed by paclitaxel) shown in red, and AC->T+H (same regimen plus trastuzumab) shown in blue. The x-axis represents overall survival in years up to 11 years, and the y-axis represents the proportion alive from 0 to 1. The graph includes a legend identifying the treatment groups and a table of number at risk below the x-axis at various time points.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

A Kaplan-Meier survival curve chart depicting disease-free survival over 5 years for three treatment groups. The x-axis represents disease-free survival in years, and the y-axis shows the proportion of event-free patients. Three curves compare AC->TH (doxorubicin + cyclophosphamide followed by docetaxel + trastuzumab), TCH (docetaxel + carboplatin + trastuzumab), and AC->T (doxorubicin + cyclophosphamide followed by docetaxel) regimens, with a legend and number at risk table below the graph.*

FDA Label Image

Herzuma 07

A survival curve graph titled 'Product-Limit Survival Estimates' showing survival probability over duration of survival in months. It compares two groups: one treated with Fluoropyrimidine plus Cisplatin, and the other with Fluoropyrimidine plus Cisplatin plus Trastuzumab. The graph includes number of subjects at risk over time and indicates censored data with plus symbols.*

FDA Label Image

Herzuma 08

Label for Herzuma (trastuzumab-pkrb) injection, showing strength of 420 mg per vial. It is a prescription-only, multiple-dose vial intended for intravenous infusion, requiring reconstitution and dilution. The label notes no preservative, instructs refrigeration, and displays the Teva logo.*

FDA Label Image

Herzuma 09

Label for HERZUMA (trastuzumab-pkrb) injection, 150 mg per vial, a single-dose vial for intravenous infusion. The label states "Rx only," instructs to discard unused portion, and indicates no preservative. It advises reconstitution and dilution as per the insert and to keep refrigerated. The label includes the Teva logo.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.