Ogivri Kit
Product Images NDC 67457-847

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Ogivri (NDC 67457-847). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Institutional 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.

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Figure 1 Studies 1 And 2: Cumulative Incidence Of Time To First Lvef (Image 01)

The text describes a graph (Figure 1) which displays the cumulative incidence of time to first LVEF decline from baseline and to below 50% with death as a competing risk event, for studies 1 and 2. The graph shows the time in years from the initiation of Pacitaxel/Trastuzumab, and the number of risks on the y-axis. The x-axis displays the years from 0 to 8. There are also some numbers (900, 1959, 1670, etc.) on the top and bottom of the graph.*

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Figure 2 Study 3: Cumulative Incidence Of Time To First Lvef Decline Of ≥ 10 Percentage Points From Baseline And To Below 50% With Death As A Competing Risk Event (Image 02)

The given text seems to be a figure showing two different studies with different groups of participants and the cumulative incidence of time to first LVEF decline of more than 10 percentage points from baseline with death as a competing risk event. The figure has a graph with numbers on the X-axis indicating time from randomization in months and numbers on the Y-axis indicating the number of participants at risk. The figure has two lines, one representing the cumulative incidence in participants who received trastuzumab for one year and the other representing the group who received observation only. No further information is available.*

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Figure 3 Study 4: Cumulative Incidence Of Time To First Lvef Decline Of ≥ 10 Percentage Points From Baseline And To Below 50% With Death As A Competing Risk Event (Image 03)

This is a figure showing the cumulative incidence of time to first LVEF decline of >10 percentage points from baseline and to below 50% with death as a competing risk event. The study compares three different treatments: the first treatment is a combination of doxorubicin and cyclophosphamide followed by docetaxel, the second treatment is the same as the first but also includes trastuzumab, and the third treatment is a combination of docetaxel, carboplatin, and trastuzumab. The graph shows the number at risk for each treatment at different time intervals.*

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Figure 4 Duration Of Disease-free Survival In Patients With Adjuvant Treatment Of Breast Cancer (studies 1 And 2) (Image 04)

The text provided is a figure labeled as "Figure 4" which shows two studies' results for the duration of disease-free survival of breast cancer patients who received adjuvant treatment. The x-axis shows the years of disease-free survival, while the y-axis shows the number at risk for each treatment group. The two studies being compared are "AC-T" and "AC-T+H", with the latter involving additional treatment with trastuzumab. There are also numerical values and symbols present but they do not provide additional information on the content of the figure.*

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Figure 5 Duration Of Overall Survival In Patients With Adjuvant Treatment Of Breast Cancer (studies 1 And 2) (Image 05)

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Figure 6 Duration Of Disease-free Survival In Patients With Adjuvant Treatment Of Breast Cancer (study 4) (Image 06)

The figure shows the duration of disease-free survival in patients with adjuvant breast cancer treatment in Study 4. Different treatment methods such as AC->T, AC->TH, TCH, and AC->T are represented with the help of Kaplan-Meier estimates. The graph shows the comparison of the treatments in terms of Disease-Free Survival in years. The number at risk is also shown on the graph. A legend is provided to explain the abbreviations used for different treatments.*

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Figure 7 Updated Overall Survival In Patients With Metastatic Gastric Cancer (study 7) (Image 07)

This is a figure showing updated overall survival in patients with metastatic gastric cancer in Study 7. The graph displays the number of subjects at risk by duration of survival in months, with product-limit survival estimates. The two treatment options depicted are fluoropyrimidine + cisplatin and fluoropyrimidine + cisplatin + trastuzumab.*

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Ogivri For Injection 420 mg/vial Carton Label (Image 08)

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Ogivri For Injection 420 mg/vial Carton Label (Image 09)

'Ogivri (trastuzumab-dkst) For Injection is a sterile, white to pale yellow lyophilized powder available in a multiple-dose vial with no preservatives. Each vial contains 420 mg of trastuzumab-dkst. It is a monoclonal antibody used for intravenous infusion after reconstitution. The drug requires refrigeration and must not be frozen or shaken after reconstitution. The text also includes information on how to reconstitute and administer the drug. It is manufactured by Mylan Pharmaceuticals and distributed by Mylan Institutional LLC. The text further includes details about batch coding, serialization, and variable data information.*

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Ogivri For Injection 150 mg/vial Carton Label (Image 10)

'Ogivri is a medication used for intravenous infusion after reconstitution, containing 180 mg trastuzumab-ghs and other substances. It has no preservatives and requires refrigeration, immediate reconstitution before use, and storage below 2° to 8° Celsius. Dosage information is included in the package, and further instructions may be necessary before use. The product should not be frozen or shaken. The text includes information on the manufacturer, lot number, and expiration date.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.