Ontruzant Kit
Product Images NDC 78206-148

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Ontruzant (NDC 78206-148). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Organon Llc, 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 (Ont02 0000 01)

A Kaplan-Meier curve showing cumulative incidence over time (years) from initiation of paclitaxel/trastuzumab. Two groups labeled AC->T (dashed line) and AC->T+H (solid line) are compared with shaded confidence intervals. The x-axis represents time in years, and the y-axis represents cumulative incidence. Below the x-axis, numbers at risk are displayed for each group at various time points.*

FDA Label Image

Figure 2 (Ont02 0000 02)

A line graph depicting cumulative incidence over time in months from randomization, comparing two groups: Observation Only and Trastuzumab 1-Year. The horizontal axis shows time in months up to 24 months with numbers at risk below, and the vertical axis shows cumulative incidence up to 0.50. The graph includes shaded confidence intervals around each line, with Trastuzumab 1-Year indicated by a solid line and Observation Only by a dashed line.*

FDA Label Image

Figure 3 (Ont02 0000 03)

A line graph depicting cumulative incidence over time (months) for three treatment regimens labeled AC->T (doxorubicin and cyclophosphamide followed by docetaxel), AC->TH (doxorubicin and cyclophosphamide followed by docetaxel plus trastuzumab), and TCH (docetaxel plus carboplatin plus trastuzumab). The X-axis represents time in months up to 36, and the Y-axis represents cumulative incidence. A risk table below the graph shows the number of subjects at risk at various time points for each treatment group.*

FDA Label Image

Figure 4 (Ont02 0000 04)

A line graph depicting disease-free survival over time (up to 3.5 years) with proportion event-free on the vertical axis. Two survival curves compare treatment regimens: a dashed line for AC followed by TH (doxorubicin + cyclophosphamide followed by paclitaxel + trastuzumab) and a solid line for AC followed by T (doxorubicin + cyclophosphamide followed by paclitaxel). Numbers at risk are shown below the graph for both groups.*

FDA Label Image

Figure 5 (Ont02 0000 05)

A survival curve graph depicting overall survival over 11 years for two treatment groups: AC->T (doxorubicin + cyclophosphamide followed by paclitaxel) shown as a solid line, and AC->T + H (same chemotherapy with added trastuzumab) shown as a dashed line. The y-axis represents the proportion alive, and the x-axis represents overall survival in years. Below the graph, a table displays the number of patients at risk for both groups at various time points.*

FDA Label Image

Figure 6 (Ont02 0000 06)

A Kaplan-Meier plot showing disease-free survival over years for three treatment groups in breast cancer therapy, comparing AC->TH (doxorubicin and cyclophosphamide followed by docetaxel plus trastuzumab), TCH (docetaxel, carboplatin, and trastuzumab), and AC->T (doxorubicin and cyclophosphamide followed by docetaxel). The y-axis represents proportion event-free, and the x-axis represents disease-free survival in years, with number at risk data included at the bottom.*

FDA Label Image

Figure 7 (Ont02 0000 07)

A Product-Limit Survival Estimates graph depicting survival probability over duration of survival in months for two treatment groups: Fluoropyrimidine + Cisplatin versus Fluoropyrimidine + Cisplatin + Trastuzumab. The graph includes censored data points and the number of subjects at risk over time.*

FDA Label Image

Samsung Bioepis Logo (Ont02 0000 08)

FDA Label Image

Merck Logo (Ont02 0000 09)

FDA Label Image

Principal Display Panel (Ontruzant Carton Label)

Label for Ontruzant (trastuzumab-dttb) 150 mg/vial, an intravenous injection kit. The label indicates it is a single-dose vial for intravenous infusion only, distributed by Organon LLC and manufactured by Samsung Bioepis. Storage instructions advise refrigeration between 2°C to 8°C and not freezing. The label includes reconstitution directions and a barcode.*

FDA Label Image

Principal Display Panel – Kit Label (Ont02 0000 11)

Ontruzant 420 mg vial kit packaging label for injection with trastuzumab-dttb, marketed by Organon LLC and Samsung Bioepis. The label states it is for intravenous infusion only, contains 420 mg trastuzumab-dttb per vial, includes instructions on storage at 2°C to 8°C, and warns not to freeze the reconstituted solution. The package includes one 420 mg vial and one vial of Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol).*

* 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.